Annual Report for Custom Devices

1

Custom Device Exemption

2
3
4
5
6
7
8

Draft Guidance for Industry and
Food and Drug Administration
Staff

9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30

DRAFT GUIDANCE
This guidance document is being distributed for comment purposes only.
Document issued on: January 14, 2014
You should submit comments and suggestions regarding this draft document within 60 days
of publication in the Federal Register of the notice announcing the availability of the draft
guidance. Submit written comments to the Division of Dockets Management (HFA-305),
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit
electronic comments to http://www.regulations.gov. Identify all comments with the docket
number listed in the notice of availability that publishes in the Federal Register.
For questions regarding this document, contact either Erin Keith or Eric Horowitz at the Center
for Devices and Radiological Health (CDRH):
Erin Keith
Office of Device Evaluation (ODE)
301-796-6384
[email protected]
31
32
33
34
35
36
37

Eric Horowitz
Office of Compliance (OC)
301-796-5597
[email protected]

U.S. Department of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health
Office of Device Evaluation
Office of Compliance

Contains Nonbinding Recommendations
Draft - Not for Implementation
38

Preface

39
40
41
42
43
44
45
46
47
48

Additional Copies
Additional copies are available from the Internet. You may also send an e-mail request to
[email protected] to receive an electronic copy of the guidance or send a fax request to 301827-8149 to receive a hard copy. Please use the document number 1820 to identify the
guidance you are requesting.

Contains Nonbinding Recommendations
Draft - Not for Implementation

Table of Contents

49
50
51

I.

Introduction ................................................................................................................................................1

52

II.

Background ................................................................................................................................................1

53

III.

Definitions .................................................................................................................................................2

54

IV.

No More Than Five Units Per Year of a Device Type ...............................................................................3

55

V.

Questions and Answers/Examples of Custom Devices ..............................................................................4

56
57
58
59
60
61
62
63
64
65
66
67
68
69
70
71
72
73
74
75
76
77
78
79

A. What premarket and postmarket requirements are my custom device exempt from fulfilling? ................4
B. The custom device exemption describes two types of custom devices: one that is specific to the special
needs of the physician’s practice, and one that is specific to the patient’s unique physiological/pathology
needs. Can a single custom device be both unique to a physician’s practice and the patient’s unique needs? ..5
C. Can a device subject to an IDE be a custom device?.................................................................................5
No, a device that is currently being studied or capable of study under an IDE does not meet the definition of a
custom device. Additionally, the IDE is a broad exemption under which devices used in clinical
investigations that meet IDE requirements are exempt (not only) from sections 514 and 515, but also from
section 502, 510, 516, 519, 510(e), 520(f) and section 721 of the FD&C Act. As discussed above, the custom
device exemption is more limited; thus, there would be no reason to seek a custom device exemption for a
device capable of study under an IDE. Custom devices represent a much narrower category of devices,
limited to devices devised for the purpose of treating sufficiently rare conditions or rare physician needs,
where conducting clinical investigations would be impractical. ........................................................................5
D. What is the relationship between compassionate use and a custom device? .............................................5
E. Can modifications to an existing 510(k)-cleared device be made under the custom device exemption? ..6
How are revisions and servicing of existing valid custom devices included in the total of five units of a
F.
device type per year? ..........................................................................................................................................6
G. Are pediatric devices automatically custom devices, simply because the device is for a pediatric
population? .........................................................................................................................................................6
H. How should I label my custom device? .....................................................................................................7
Can I market my custom device to the general public? .............................................................................7
I.
What are some examples of devices that are potential custom devices? ...................................................7
J.
K. What are some examples of a device that is not a custom device?............................................................8
Annual Report ............................................................................................................................................8
VI.

80
81

1.

Annual Report – General Contents ............................................................................................................9
Cover Letter ........................................................................................................................................9

82

2.

Certification Statement.......................................................................................................................9

83

3.

Other Logistical Information .............................................................................................................9

84
85
86
87
88
89

A.

B. Annual Report -- Patient-Centric Custom Device Information ............................................................... 10
As described in Section IV of this guidance, a custom device is either patient-centric or physician/dentistcentric, but not both. In addition to the requested elements listed in Section V.A. (above) the following
elements should be provided to FDA in a Custom Device Annual Report for patient-centric devices to ensure
that the conditions listed in sections 520(b)(1) and 520(b)(2) are met. ............................................................ 10
Explanation of how the device satisfies the elements of Section 520(b) of the FD&C Act .......... 10
1.

90

2.

Summary of Custom Devices Shipped, Used, and Returned......................................................... 11

91

3.

Details on Custom Device Use .......................................................................................................... 11

92
93
94
95
96
97
98

C. Annual Report –Physician or Dentist-Centric Custom Device Information............................................ 12
As described in Section IV of this guidance, a custom device is either considered to be patient-centric or
physician/dentist-centric, but not both. In addition to the requested elements listed in Section V.A. (above)
the following elements should be provided to FDA in a Custom Device Annual Report for a physician-centric
device to ensure that the conditions listed in sections 520(b)(1) and 520(b)(2) are met. ................................. 12
Explanation of how the device satisfies the elements of Section 520(b) of the FD&C Act .......... 12
1.
2.

Accommodating a Doctor’s or Dentist’s Special Need ................................................................... 13

3.

99
100
101
102
103

Contains Nonbinding Recommendations
Draft - Not for Implementation

Details on Custom Device Use .......................................................................................................... 13

Custom device or custom device components. You should provide information on the number of
b)
custom devices or custom device components that were shipped, sold, and returned during the reporting
period. This includes the product name, brand name, product model number, product catalog number,
other product identifier information, product code, and product classification regulation. .......................... 14

104
105

D.
VII.

106
107

Please see Appendix III for a flow diagram of the decision tree needed to implement the custom device
provisions in the FD&C Act. ................................................................................................................................ 15

108

Appendix I ............................................................................................................................................................ 16

109

Appendix II ......................................................................................................................................................... 18

110

Custom Device Annual Report Truthful And Accurate Statement ............................................................... 18

111

Appendix III ......................................................................................................................................................... 19

112

Custom Device Decision Tree .............................................................................................................................. 19

113

FDA’s Review of Your Annual Report ................................................................................................... 14
Complete Text of Section 520(b) of the Food, Drug and Cosmetic Act .................................................. 14

Contains Nonbinding Recommendations
Draft - Not for Implementation

Custom Device Exemption

114
115
116

Draft Guidance for Industry and
Food and Drug Administration Staff

117
118
119
120
121
122
123
124
125
126
127

This draft guidance, when finalized, will represent the Food and Drug Administration's
(FDA's) current thinking on this topic. It does not create or confer any rights for or on
any person and does not operate to bind FDA or the public. You can use an alternative
approach if the approach satisfies the requirements of the applicable statutes and
regulations. If you want to discuss an alternative approach, contact the FDA staff
responsible for implementing this guidance. If you cannot identify the appropriate FDA
staff, call the appropriate number listed on the title page of this guidance.

128

I.

129
130
131
132
133
134
135
136
137
138
139
140
141

The Food and Drug Administration (FDA) has developed this draft document to provide
guidance to industry and FDA staff about implementation of the custom device exemption
contained in Section 520(b) the Food, Drug and Cosmetic Act (FD&C Act). The guidance
provides draft definitions of terms used in the custom device exemption, explains how FDA
proposes to interpret the “5 units per year of a particular device type” language contained in
section 520(b)(2)(B), describes what information FDA proposes should be submitted in a
Custom Device Annual Report (annual report), and provides recommendations on how to
submit an annual report for devices distributed under the custom device exemption.
FDA's guidance documents, including this guidance, do not establish legally enforceable
responsibilities. Instead, guidances describe the Agency's current thinking on a topic and
should be viewed only as recommendations, unless specific regulatory or statutory
requirements are cited. The use of the word should in Agency guidances means that
something is suggested or recommended, but not required.

142

II. Background

143
144
145
146
147
148
149
150
151
152

Introduction

Effective on July 9, 2012, section 617 of the Food and Drug Administration Safety and
Innovation Act (FDASIA) (Pub. L. 112-144) required the implementation of changes to the
custom device exemption contained in section 520(b) of the FD&C Act. The new provision
amended an existing custom device exemption and introduced new concepts and procedures
for custom devices, such as:
•
•

devices created or modified in order to comply with the order of an individual
physician or dentist;
the potential for multiple units of a device type (not to exceed 5 units per year)
qualifying for the custom device exemption; and
1

Contains Nonbinding Recommendations
Draft - Not for Implementation
153
154
155
156
157
158
159
160
161
162
163
164
165
166
167
168
169
170
171
172
173
174
175
176
177
178
179
180
181
182
183
184
185
186
187
188
189
190
191
192
193

•

annual reporting requirements by the manufacturer to FDA about devices
manufactured and distributed under section 520(b) of the FD&C Act.

Although the revisions to the custom device exemption clarify the availability of the
exemption in certain circumstances – for example, when more than one (but fewer than five)
devices are manufactured per year and when modifications are made to a marketed device –
the new statutory language does not create a broad, new exemption from sections 514 and
515 of the FD&C Act. Under the revised provision, as under the original custom device
exemption, custom devices should represent a narrow category for which, because of the
rarity of the patient’s medical condition or physician’s special need, requiring compliance
with premarket review requirements and performance standards under sections 514 and 515
of the FD&C Act is impractical.
Historically, practitioners and manufacturers have sought custom device exemptions for
devices more properly considered under a compassionate use protocol. FDA notes that
some devices deemed ineligible for custom devices status prior to FDASIA would remain
ineligible under the new provision, but may qualify for compassionate use. Although a full
discussion of compassionate use is outside the scope of this guidance, a short discussion of
compassionate use is included in the Question and Answer section of this draft guidance.

III. Definitions
Device Type
A generic device type is defined as a grouping of devices that do not differ significantly
in purpose, design, materials, energy source, function, or any other feature related to
safety and effectiveness, and for which similar regulatory controls are sufficient to
provide reasonable assurance of safety and effectiveness. (21 CFR 860.3(i)). For the
purposes of this guidance, “device type” more specifically describes devices with
common design characteristics and indication/intended use, such as those devices defined
by an FDA classification regulation or product code.
Importer
“Importer” means any person who imports a device into the United States. 1
Necessarily Deviates
“Necessarily deviates” means that a device should be sufficiently unique so that clinical
investigations would be impractical, and could not be performed to demonstrate conformance
to applicable performance standards and/or support premarket review. 2
Not Generally Available
A device that is “not generally available” is a device not generally available in finished form
and that is not advertised by the manufacturer, importer, or distributor for manufacture and/or
commercial distribution in the United States and is of a type available [for introduction into
1
2

21 CFR 806.2(f).
48 FR 248 Pages 56778, 56796, December 23, 1983.

2

Contains Nonbinding Recommendations
Draft - Not for Implementation
194
195
196
197
198
199
200
201
202
203
204
205
206
207
208
209
210
211
212
213
214
215
216
217
218
219
220
221
222
223
224
225
226
227
228
229
230
231
232
233
234
235

commercial distribution] in quantities of less than five units per year. This includes, but is
not limited to, devices without electronic or hard copy literature, promotional material, or
testimonials available. For example, a manufacturer could make a custom device in response
to an unsolicited request by a physician who specifies unique design inputs when no similar
product is commercially available in the United States and clinical investigations would be
impractical.
Order of a Physician
“Order of a physician” refers to the written request for a custom device made by a physician,
dentist, or other specially qualified person designated by FDA regulation. In the case of a
prescription device, this would include the written or electronic prescription.
Special Need
A “special need” is a need that is related to unusual anatomical features of the individual
doctor, dentist or any other specially qualified person designated under regulations
promulgated by the Secretary. 3
Sufficiently Rare Condition
A “sufficiently rare condition” is a condition in a patient population in which the incidence or
prevalence is so small that conducting clinical investigations on such device would be
impractical.
Unique Pathology
“Unique pathology” is pathological anatomy that no other device is domestically available to
treat.
Unique Physiologic Condition
A “unique physiologic condition” is one that no other device is domestically available to
treat.

IV. No More Than Five Units Per Year of a Device Type
Under FDASIA, “devices” that qualify for the custom device exemption contained in section
520(b) of the FD&C Act are “limited to no more than 5 units per year of a particular device
type” that otherwise meet all the requirements necessary to qualify for the custom device
exemption.
FDA interprets the five units in terms of five new custom device cases per year (i.e., five new
patients for the patient-focused custom device or five new physicians for the physicianfocused custom device, assuming all other required elements for the custom device
exemption are satisfied). The five unit limitation includes all devices provided by a
manufacturer to, and remaining in the possession of, the ordering physician and/or the
patient. FDA does not intend to include in the tally of five units per year any extra units that
are produced for a unique case because of sizing concerns, so long as those devices not used
3

43 FR 20726, 20747-49, May 12, 1978; 45 FR 3732 and 3740, January 18, 1980.

3

Contains Nonbinding Recommendations
Draft - Not for Implementation
236
237
238
239
240
241
242
243
244
245
246
247
248
249
250
251
252
253
254
255
256
257
258
259
260
261
262
263
264
265

for that unique case are returned to the manufacturer, and not redistributed without either
valid marketing authorization or for a subsequent valid custom device case. FDA
recommends that these extra units be destroyed and a signed record of the destruction be
maintained in the manufacturer’s device history record. For example, if four sizes of a valid
custom orthopedic implant are manufactured for a specific patient’s need and one device is
ultimately implanted into the patient, then the remaining three sizes should be returned to the
manufacturer. If these units are not returned to the manufacturer, then FDA considers four of
the five total units per year to have been used for this one patient. On the other hand, if the
three other units are returned to the manufacturer, only one of the five units per year will
have been used to treat this patient, provided the returned devices are not redistributed
without either valid marketing authorization or for use in a subsequent valid custom device
case.
The devices used in the case where a patient requires multiple devices of the same type (such
as bilateral conditions) requiring treatment of multiple anatomical locations within a given
reporting year, will be considered one unit for the purposes of tallying the five units of a
device type per year, so long as those devices not used for that unique case are returned to the
manufacturer, and not redistributed without either valid marketing authorization or for use in
a subsequent valid custom device case. For example, in the event valid bilateral custom joint
replacement devices (such as might occur in bilateral knee replacement procedures) are
required for a given patient, so long as the patient’s joint replacement procedures occur in the
same reporting year, and all unused product is returned to the manufacturer, FDA will
consider the multiple joint replacement devices needed to treat the bilateral patient as a single
unit in the tally of five units per year of a device type. If the treatment of the patient’s
multiple anatomical locations occur during different reporting years, each treatment will
contribute one unit each to the tally for the reporting year in which the treatment occurs (so
long as devices not used for that unique case are returned to the manufacturer, and not
redistributed without either a valid marketing authorization or for use in a subsequent valid
custom device case).

V.

Questions and Answers/Examples of Custom Devices

266
267

A.

What premarket and postmarket requirements are my custom device exempt
from fulfilling?

268
269
270
271
272
273

Under Section 520(b) of the FD&C Act, custom devices are exempt from Premarket
Approval (PMA) requirements, as well as conformance to mandatory performance
standards. 4 Custom Devices are not exempt from any other requirements, including,
but not limited to, the Quality System Regulation, including Design Controls (21 CFR
Part 820); Medical Device Reporting (21 CFR Part 803); Corrections and Removals
(21 CFR Part 806); and Registration and Listing (21 CFR Part 807).
4

A device not covered by an existing marketing approval would require either a PMA or a valid exemption to
the requirements to obtain PMA approval in order to introduce the device into interstate commerce. Examples
of potential valid exemptions or alternatives to the PMA requirement include: (1) establishing the substantial
equivalence of the new device to a valid predicate device, (2) approval of an Investigational Device Exemption
(IDE) or (3) meeting all the requirements for the custom device exemption.

4

Contains Nonbinding Recommendations
Draft - Not for Implementation
274
275
276
277
278

B.

The custom device exemption describes two types of custom devices: one
that is specific to the special needs of the physician’s practice, and one that
is specific to the patient’s unique physiological/pathology needs. Can a
single custom device be both unique to a physician’s practice and the
patient’s unique needs?

279
280
281
282
283
284
285

No, the custom device provision allows for two different categories of custom devices
to be developed. One is patient-centric and the other is physician/dentist-centric; a
custom device cannot be both patient and physician/dentist-centric. A custom device
made to treat a patient’s sufficiently rare condition leaves the medical/dental practice
with the patient, while a custom device made to satisfy a sufficiently unique special
need for the physician/dentist stays with that physician/dentist for use in his/her
practice.

286

C.

287
288
289
290
291
292
293
294
295
296

No, a device that is currently being studied or capable of study under an IDE does not
meet the definition of a custom device. Additionally, the IDE is a broad exemption
under which devices used in clinical investigations that meet IDE requirements are
exempt (not only) from sections 514 and 515, but also from section 502, 510, 516,
519, 510(e), 520(f) and section 721 of the FD&C Act. As discussed above, the
custom device exemption is more limited; thus, there would be no reason to seek a
custom device exemption for a device capable of study under an IDE. Custom
devices represent a much narrower category of devices, limited to devices devised for
the purpose of treating sufficiently rare conditions or rare physician needs, where
conducting clinical investigations would be impractical.

297

D.

298
299
300
301
302
303
304
305
306
307
308
309
310
311
312
313
314
315

Devices that do not meet all of the elements of the custom device definition described
in section 520(b) of the Act may still qualify for compassionate use. FDA provides
information on how to request a compassionate use of an unapproved device in the
guidance document “Guidance on IDE Policies and Procedures”
(http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocu
ments/ucm080202.htm).

Can a device subject to an IDE be a custom device?

What is the relationship between compassionate use and a custom device?

“Compassionate use” of an unapproved device may occur when a device that is being
tested in a clinical trial under IDE is the only option available for a patient faced with
a serious condition. In cases where a sponsor seeks compassionate use of a device
that does not have an approved IDE in effect, please contact the CDRH IDE Staff to
discuss potential compassionate use of the device. All compassionate uses require
prior FDA approval under 21 CFR 812.35(a) and this approval must be obtained
before the device is used. In order to obtain Agency approval, the sponsor should
submit an IDE supplement requesting approval for a protocol deviation in order to
treat the patient. Please refer to the guidance listed above for more information on the
compassionate use of unapproved devices.

5

Contains Nonbinding Recommendations
Draft - Not for Implementation
316
317

E.

Can modifications to an existing 510(k)-cleared device be made under the
custom device exemption?

318
319
320
321
322
323
324
325
326
327
328
329
330
331
332
333
334
335
336
337
338
339
340
341
342
343

Modifications to a 510(k)-cleared device that maintains the original intended use and
could be clinically studied would not be considered appropriate as a custom device
and should be handled in accordance with 21 CFR 807.81 and the guidance document
“Deciding When to Submit a 510(k) for a Change to an Existing Device (K97-1)”
(http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocument
s/ucm080235.htm) (i.e., submission of a new 510(k) application or documentation to
the design history file explaining why the change does not require a new 510(k), as
appropriate). However, if an existing 510(k)-cleared device is modified in order to
treat a unique pathology or unique physiological condition, which render it incapable
of clinical study, the device could potentially qualify as a custom device.

344
345

F.

346
347
348
349
350
351
352
353

A device that meets all of the requirements of section 520(b) of the FD&C Act when
initially distributed will not be counted against the five units of a device per year if it
has later been revised or serviced, provided that such revision or servicing is
performed in furtherance of meeting the special needs of the person, physician, or
dentist for whom the custom device was initially intended prior to such revision
and/or servicing. You should contact CDRH’s Office of Compliance to discuss the
specifics of your situation prior to undertaking the revision or servicing of such
device, as discussed herein.

354
355

G.

356
357

No. Pediatric patient populations may be studied just as with adult populations, and
to the extent that it is possible, they should be studied so that proper labeling of a

It is worth noting that FDA reviews, clears, and approves for marketing many patientspecific devices (also referred to as patient-matched devices). Patient-specific
devices are, in general, ones in which ranges of different specifications have been
approved or cleared to treat patient populations that can be studied clinically.
Premarket submissions for such devices are sometimes referred to as “envelope”
submissions because approval or clearance of the submission covers the entire range
of specifications supported by data in the submission. The final manufacturing of
these devices can be delayed until the physician provides imaging data or other
information to the manufacturer to finalize the specifications of the device within the
cleared or approved ranges. As a result, the device is specifically tailored for the
patient. While these devices have sometimes colloquially been referred to as
“customized,” these devices are not custom devices per the requirements of the
custom device exemption in the FD&C Act. Marketing applications are required for
these device types because both the device and patient population can be defined and
studied.
How are revisions and servicing of existing valid custom devices included in
the total of five units of a device type per year?

Are pediatric devices automatically custom devices, simply because the
device is for a pediatric population?

6

Contains Nonbinding Recommendations
Draft - Not for Implementation
358
359

device may be created. The proper labeling can guide users toward a better
understanding of performance characteristics of the device.

360

H.

361
362
363
364
365
366
367
368

Custom devices remain subject to all of the labeling requirements, such as the
requirement that the labeling bear adequate directions for use, may not be false or
misleading, and many other requirements related to labeling, including 21 CFR 801.1.
In addition, the labeling of a custom device should include the following information:
(1) a statement the device is a custom device; (2) the name of the ordering
physician/dentist and patient (if applicable) that the device is intended to treat; (3)
indications for use; (4) sterilization status; (5) relevant composition information
(materials, components, etc.); and (6) storage conditions. 5

369

I.

370
371
372
373
374
375

No. A custom device is made as a special order at the request of a physician/dentist
to be used on patients with a sufficiently rare condition or for a physician/dentist’s
special needs (i.e., unusual anatomical features) for no more than five units per year
of a device type. Section 520(b)(1)(C) sets forth that a custom device is not, among
other things, made generally available in finished form through labeling or
advertising.

376

J.

377
378
379
380
381
382
383
384
385
386
387
388
389
390
391
392

A possible example of a custom device might be one manufactured for a patient with
skeletal dysplasia requiring a total hip replacement procedure to treat her
osteoarthritis. The patient’s skeletal dysplasia could be characterized by
abnormalities in the growth and/or remodeling of cartilage and bone, resulting in
short stature and angular and torsional deformities of the patient’s hip. In this
particular case it is possible that the patient’s unique pathological anatomy might not
be successfully treated with the currently available total hip replacement devices
marketed in the United States. Other elements of the custom device exemption would
need to be met, such as the patient population being too small to support a clinical
study.

How should I label my custom device?

Can I market my custom device to the general public?

What are some examples of devices that are potential custom devices? 6

Another possible example of a custom device might be an artificial cervical disc
replacement for reconstruction of the cervical disc following cervical discectomy for
treatment of cervical radiculopathy in a 7’2” male patient. Under this hypothetical
scenario, the osseous dimensions of this patient's cervical spine are such that the
dimensions exceed those which would be accommodated by a cervical disc available
5

For additional information on device labeling, refer to 21 CFR Part 801 and “Guidance on Medical Device
Patient Labeling”
(http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm070782.htm).
6
This is not intended to be an exhaustive list of devices that might satisfy the custom device exemption, and it
represents only a subset of the information needed to meet the statutory requirements for a valid custom device.
If you have questions as to whether your scenario might satisfy the custom device exemption, we encourage you
to contact CDRH’s Office of Compliance to discuss.

7

Contains Nonbinding Recommendations
Draft - Not for Implementation
393
394
395
396
397
398
399
400
401
402
403
404
405
406
407

in the United States and the patient represents a population which, at this time,
appears to be too small to support a clinical study.

408

K.

409
410
411
412
413
414
415
416
417

A primary total knee replacement (TKR) patient received company X’s TKR device.
Later, the patient needs a revision of one side of the TKR joint replacement, and
could have this accomplished by utilizing company X’s off-the-shelf component for
revision surgeries. However, the hospital where the patient’s doctor practices only
uses company Y’s products. The doctor would like to request a custom company Y
component be made to replace the patient’s failing company X component. This
situation would not satisfy the requirements for a custom device exemption because a
device is available domestically that could be used to treat the patient. See Section
520(b)(1)(D) of the FD&C Act.

418
419
420
421
422
423
424
425
426
427
428
429
430
431
432
433
434
435

An additional example of a possible custom device might be one manufactured for a
toddler needing occipital condyle screws after surviving a severe car accident, leaving
her paralyzed from the neck down and in need of instrumentation that would help
hold her head up. Her physician concludes that an occiput to C2 posterior cervical
fusion would be best for the patient. In the United States, there are no cleared or
approved screws for placement in the occipital condyle available in the sizes needed
for this pediatric patient population. At this time the pediatric patient population
needing posterior occipital condyle fusion within the size range needed for the toddler
could be too small to support a clinical study. This scenario might satisfy the custom
device exemption, and the physician should request custom occipitocervical implants
for non-standard, pediatric sized screws for use in the occiput, cervical spine, and
upper thoracic spine of this specific patient.
What are some examples of a device that is not a custom device?

VI. Annual Report
The statutory amendments to the custom device exemption under FDASIA added a new
reporting requirement:
“… the manufacturer of such [custom]device notifies the Secretary on an annual basis, in a
manner to be prescribed by the Secretary, of the manufacture of such device.”
The manufacturer of the custom device must report to FDA annually, as required by section
520(b)(2)(C) of the FD&C Act, on the custom devices it supplied. The annual report should
include the number of patients who received a new device or revisions of a previous custom
device. Additionally, multiple custom devices or components used in one patient should be
accounted for in the annual report. As noted in Section III of this guidance, typically only
new custom devices will be counted toward the maximum amount of five units per year of a
particular device type. However, revisions to an existing custom device should be accounted
for in the annual report. In addition, the number of custom devices both provided to, and
returned by, physicians or dentists to accommodate unusual anatomical features of the
individual patient, physician or dentist should be accounted for in the annual report.

8

Contains Nonbinding Recommendations
Draft - Not for Implementation
436
437
438
439
440
441
442
443
444
445
446
447
448
449
450
451

The annual report should summarize the number of custom devices manufactured and
distributed in the United States during a 1-year reporting period. Each annual report should
cover a given calendar year. The first report should contain retrospective information on
custom devices provided by manufacturers from the date of enactment of FDASIA (on July
9, 2012) to the date of the first report. For all subsequent reporting periods, the report should
be submitted to FDA within the first quarter of the following calendar year (e.g., by no later
than March 31.). FDA will not enforce the new annual reporting requirement until the end of
the calendar year following publication of the final guidance; however, FDA encourages
manufacturers to submit the information required by the statute in any format in advance of
the finalized guidance being published.
A complete annual report should include all of the information as set forth below. FDA
believes it can review a complete annual report more efficiently and may be less likely to
request additional information. The following sections provide guidance on how to submit
the annual notification (e.g., the annual report) to FDA and the content of that report for both
patient-centric and physician-centric custom devices.

452

A.

Annual Report – General Contents

453
454

The following general information should be included in both patient-centric and
physician-centric annual reports.

455

1. Cover Letter

456
457
458
459
460
461
462
463
464
465

Your report should include a cover letter that clearly states that the reason for
the submission is a “Custom Device Annual Report” in the reference line.
The cover letter should contain your complete contact information (i.e., the
company name, address, URL, contact person, title, phone number, fax
number, and email address). In addition to describing the reason for the
submission in the reference line, the cover letter should also clearly identify
the name of the custom devices and include the signature of the contact person
or other responsible party within the company. The cover letter should also
specify the reporting period (i.e., the dates the reporting period begins and
ends).

466

2. Certification Statement

467
468
469
470
471
472
473

Your report should include a signed Custom Device Annual Report Truthful
and Accurate certification statement that indicates that the submitter is an
authorized representative for the manufacturer and that all the information
provided in the paper and electronic copies of the Custom Device Annual
Report is truthful and accurate to the best of your knowledge and that no
material fact has been omitted. See Appendix II for a copy of the statement
certificate.

474

3. Other Logistical Information

475
476
477
478

Your Custom Device Annual Report should be written in the English
language. Any material provided in a foreign language should be
accompanied by an accurate and complete English translation. You should
send two copies of your Custom Device Annual Report to the address below.
9

Contains Nonbinding Recommendations
Draft - Not for Implementation
We strongly encourage that one or both of your copies be an electronic copy,
which can be e-mailed to [email protected].

479
480
481
482
483
484
485
486
487
488
489

Attn: Custom Device Annual Report Submission Coordinator
Division of Analysis and Program Operations
Office of Compliance
Center for Devices and Radiological Health
U.S. Food and Drug Administration
WO66, Room 2654
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002

490

B.

Annual Report -- Patient-Centric Custom Device Information

491
492
493
494
495

As described in Section IV of this guidance, a custom device is either patient-centric
or physician/dentist-centric, but not both. In addition to the requested elements listed
in Section V.A. (above) the following elements should be provided to FDA in a
Custom Device Annual Report for patient-centric devices to ensure that the
conditions listed in sections 520(b)(1) and 520(b)(2) are met.

496
497

1. Explanation of how the device satisfies the elements of Section 520(b)
of the FD&C Act

498
499
500

In your report, you should include a justification for how or why the device
manufactured to treat an individual patient meets each of the following
conditions contained in the FD&C Act 7:

501
502
503
504
505
506
507
508
509
510
511
512
513

a) In order to explain how sections 520(b)(1)(B) and (b)(2)(A) are met,

514
515
516
517

b) In order to explain how section 520(b)(1)(A) is met, you should
indicate whether the device is a newly created device or modified from an
existing legally marketed device in order to comply with the order of an
individual physician or dentist.

518
519

c) In order to explain how section 520(b)(1)(C) is met, you should attest
that the device is not generally available in the United States in finished

you should provide an explanation of why the device necessarily deviates
from the premarket requirements including treating a sufficiently rare
condition such that conducting clinical investigations are impractical. You
may include information on the incidence or prevalence of the condition
or disease the device is intended to diagnosis, treat, mitigate, prevent, or
cure or is otherwise intended to affect the structure or any function of the
body of man. References for the data provided should also be included. If
the incidence or prevalence material referenced is not available in the
published literature, you should include a copy of the reference in the
annual report. If you believe that information on the incidence or
prevalence of the condition or disease is not available, please provide an
explanation why you believe the information is not available.

7

See Section VI of this guidance document for the complete text contained in section 520(b) of the FD&C Act.

10

Contains Nonbinding Recommendations
Draft - Not for Implementation
520
521

form through labeling or advertising by the manufacturer, importer, or
distributor for commercial distribution.

522
523
524
525
526

d) In order to explain how part of section 520(b)(1)(D) and section
520(b)(2)(B) are met, you should provide a complete description of the
device including device type (e.g., product code and classification
regulation, as applicable), as well as the patient’s unique pathology or
physiological condition the device was designed to treat.

527
528
529
530
531
532

e) In order to show that section 520(b)(1)(D) is met, you should provide a
statement that no other device is domestically available to treat the
patient’s unique pathology or physiological condition. You should
maintain records of the evaluation that you used to determine that no other
device is domestically available to treat the patient’s unique pathology or
physiological condition.

533
534
535

f) In order to explain how section 520(b)(1)(E)(ii) is met, you should
provide the name of the individual patient in the physician’s or dentist’s
order.

536
537
538
539
540
541
542

g) In order to explain how section 520(b)(1)(F) is met, you should state
whether the device is assembled from components or manufactured and
finished on a case-by-case basis to accommodate the unique needs of
individuals. Additionally, you should explain under section 520(b)(1)(G)
whether the device or device components have common, standardized
design characteristics, chemical and material compositions, and the same
manufacturing processes as commercially distributed devices.

543

2. Summary of Custom Devices Shipped, Used, and Returned

544
545
546
547
548
549
550
551
552

You should provide an annual summary of all the custom devices supplied,
used, and returned during the reporting period. This includes a name or
description of the device, the classification regulation (if applicable), and
product code (if available). This summary should also include information on
the number of each type of device that was shipped, used/remaining with the
patient (e.g., implanted) in new and revision patients, and the number of
custom devices that were returned to the manufacturer/distributor. In order to
facilitate FDA’s review of your summary report, we recommend using the
format described in Table 1 of Appendix I for reporting this information.

553

3. Details on Custom Device Use

554
555
556
557
558
559
560
561
562

You should provide the following detailed information on custom devices
manufactured during the reporting period.
a) Patient Information. You should indicate the total number of patients
receiving custom devices. This should be broken down into patients
receiving a new device, and those undergoing revisions of previously
existing custom devices. Additional information on the patients should
also be provided. This includes patient identifiers (e.g., initials/name and
age), date of the procedure or implant, and a description of the condition
11

Contains Nonbinding Recommendations
Draft - Not for Implementation
563

that necessitated use of a custom device.

564
565
566

b) Physician information. You should provide the name, address, and
other contact information for the treating physician for each patient
procedure.

567
568
569
570
571
572

c) Custom device or custom device components. For each custom device
or device component remaining with the patient, you should provide
details on each device or device component. These details should include
the product name, brand name, product model number, product catalog
number, other product identifier information, product code, and product
classification regulation.
In order to facilitate FDA’s review of your detailed custom device report,
FDA recommends the format described in Table 2 in Appendix I for
presenting patient, physician, and device information.

573
574
575
576

C.

Annual Report –Physician or Dentist-Centric Custom Device Information

577
578
579
580
581

As described in Section IV of this guidance, a custom device is either considered to
be patient-centric or physician/dentist-centric, but not both. In addition to the
requested elements listed in Section V.A. (above) the following elements should be
provided to FDA in a Custom Device Annual Report for a physician-centric device to
ensure that the conditions listed in sections 520(b)(1) and 520(b)(2) are met.

582
583

1. Explanation of how the device satisfies the elements of Section 520(b)
of the FD&C Act

584
585
586
587

In your report, you should include a justification for how or why the device
manufactured meets the special needs of a doctor or dentist in the course of
his/her professional practice and satisfies each of the following conditions
contained in the FD&C Act 8:
a) In order to explain how sections 520(b)(1)(B) and (b)(2)(A) are met,
you should provide an explanation of why the device necessarily deviates
from the premarket requirements including addressing a sufficiently rare
condition such that conducting clinical investigations are impractical. You
may include information on the incidence or prevalence of the condition
or disease the device is intended to diagnose, treat, mitigate, or prevent.
References for the data provided should be included. If the incidence or
prevalence material referenced is not available in the published literature,
you should include a copy of the reference in the annual report. In
addition, you should include an explanation of why conducting clinical
investigations on such device would be impractical. If you believe that
information on the incidence or prevalence of the condition or disease is
not available, please identify why you believe the information is not
available.

588
589
590
591
592
593
594
595
596
597
598
599
600
601

8

See Section VI of this guidance document for the complete text contained in section 520(b) of the FD&C Act.

12

Contains Nonbinding Recommendations
Draft - Not for Implementation
602
603
604
605
606

b) In order to explain how section 520(b)(1)(A) is met, you should
indicate if the device was a newly created device or modified from an
existing legally marketed device in order to comply with the order of an
individual physician or dentist, as well as the name of the individual
doctor or dentist in the order.

607
608
609
610

c) In order to explain how section 520(b)(1)(C) is met, you should attest
that the device is not generally available in the United States in finished
form through labeling or advertising by the manufacturer, importer, or
distributor for commercial distribution.

611
612
613
614
615

d) In order to explain how part of section 520(b)(1)(D) and section
520(b)(2)(B) are met, you should provide a complete description of the
device including device type (i.e., product code and classification
regulation as applicable), as well as the doctor’s or the dentist’s special
need that the device was designed to meet.

616
617
618
619
620
621

e) In order to show that sections 520(b)(1)(D) and 520(b)(1)(E)(i) are
met, you should provide a statement that no other device is domestically
available to address the doctor’s or dentist’s special need in the course of
conducting his/her practice. You should maintain records of the
evaluation that you used to determine that no other device is domestically
available to address the doctor’s or dentist’s special needs are met.

622
623
624
625
626
627
628
629

f) In order to explain how section 520(b)(1)(F) is met, you should
provide an explanation if the device was assembled from components or
manufactured and finished on a case-by-case basis to accommodate the
special needs of individuals described above. Additionally, you should
explain under section 520(b)(1)(G) whether the device or device
components have common, standardized design characteristics, chemical
and material compositions, and manufacturing processes as commercially
distributed devices.

630

2. Accommodating a Doctor’s or Dentist’s Special Need

631
632
633
634
635
636
637
638
639

You should provide an annual summary of all the custom devices both
supplied to, and returned by, a physician or dentist to accommodate a special
need. This information should include the name or description of the device,
classification regulation, and product code (if available). This summary
should also include information on the number of each type of device that was
shipped/used during the reporting period and the number of custom devices
that were returned to the manufacturer/distributor. In order to facilitate FDA’s
review of your summary custom device report, we recommend the format
described in Table 1 in Appendix I for reporting this information.

640

3. Details on Custom Device Use

641
642

You should provide the following detailed information on custom devices
distributed during the reporting period:

643
644

a) Physician information. You should provide the name, address, and
other contact information for the doctor or dentist ordering the custom
13

Contains Nonbinding Recommendations
Draft - Not for Implementation
645

device.

646
647
648
649
650
651

b) Custom device or custom device components. You should provide
information on the number of custom devices or custom device
components that were shipped, sold, and returned during the reporting
period. This includes the product name, brand name, product model
number, product catalog number, other product identifier information,
product code, and product classification regulation.

652
653
654

In order to facilitate FDA’s review of your detailed custom device report,
FDA recommends the format described in Table 3 in Appendix I for
presenting physician and device information.

655

D.

FDA’s Review of Your Annual Report

656
657
658
659
660
661
662
663

FDA's review of annual reports allow the agency to assess several important issues
related to the manufacture and distribution of custom devices. These issues include
the adequacy of report documentation and fulfillment of the requirements of section
520(b) of the FD&C Act. If we find that the information provided in your annual
report is insufficient to allow a complete review, we may request additional
information by letter, telephone, or e-mail. 9 If we only need clarification of an issue,
we may communicate on such issues via telephone or e-mail, whichever we believe
will be the most efficient.

665

VII. Complete Text of Section 520(b) of the Food, Drug
and Cosmetic Act

666
667
668
669
670
671
672
673
674
675
676
677
678
679
680
681

Section 520(b) (21 U.S.C. 360j(b)) is amended to read as follows:
(b) CUSTOM DEVICES.—
(1) IN GENERAL.—The requirements of sections 514 and 515 shall not apply to a device
that—
(A) is created or modified in order to comply with the order of an individual
physician or dentist (or any other specially qualified person designated under
regulations promulgated by the Secretary after an opportunity for an oral hearing);
(B) in order to comply with an order described in subparagraph (A), necessarily
deviates from an otherwise applicable performance standard under section 514 or
requirement under section 515;
(C) is not generally available in the United States in finished form through labeling or
advertising by the manufacturer, importer, or distributor for commercial distribution;
(D) is designed to treat a unique pathology or physiological condition that no other
device is domestically available to treat;
(E)(i) is intended to meet the special needs of such physician or dentist (or other
specially qualified person so designated) in the course of the professional practice of

664

9

The FD&C Act now requires that custom device manufacturers submit annual reports for all devices
distributed under the custom device exemption. Without submission of the required annual report to FDA, any
devices distributed as “custom devices” would not be exempted from any applicable premarket requirements.

14

Contains Nonbinding Recommendations
Draft - Not for Implementation
682
683
684
685
686
687
688
689
690
691
692
693
694
695
696
697
698
699
700

such physician or dentist (or other specially qualified person so designated); or (ii) is
intended for use by an individual patient named in such order of such physician or
dentist (or other specially qualified person so designated);
(F) is assembled from components or manufactured and finished on a case-by-case
basis to accommodate the unique needs of individuals described in clause (i) or (ii)
of subparagraph (E); and
(G) may have common, standardized design characteristics, chemical and material
compositions, and manufacturing processes as commercially distributed devices.
(2) LIMITATIONS.—Paragraph (1) shall apply to a device only if—
(A) such device is for the purpose of treating a sufficiently rare condition, such that
conducting clinical investigations on such device would be impractical;
(B) production of such device under paragraph (1) is limited to no more than 5 units
per year of a particular device type, provided that such replication otherwise complies
with this section; and
(C) the manufacturer of such device notifies the Secretary on an annual basis, in a
manner prescribed by the Secretary, of the manufacture of such device.
(3) GUIDANCE.—Not later than 2 years after the date of enactment of this section, the
Secretary shall issue final guidance on replication of multiple devices described in paragraph
(2)(B).

701
702

Please see Appendix III for a flow diagram of the decision tree needed to implement the
custom device provisions in the FD&C Act.

15

Contains Nonbinding Recommendations
Draft - Not for Implementation

Appendix I
Format for Summary Data Tables

703
704
705
706

Table 1. Summary of Custom Devices Shipped, Used and Returned
Custom Device
Name

707
708

Product Code

Number
Shipped

Number of New Cases
Patient-Centric or
Physician-Centric (as
applicable)

Number of Revision
Cases (Patient-Centric or
Physician-Centric)

Number
Returned

Table 2. Patient-Centric Devices - Summary of Patient, Physician and Device Information for Patient-Centric Devices
Patient
Identifiers

Date of
procedure/
implant

Description of the
condition that
necessitated use of
a custom device
and alternative
treatments

Name and
address of
physician

Custom device name or
custom device components

Other relevant Information

Product name,
Brand name,
Product model number,
Product catalog number
Other product identifier
information
Product code,
Product classification
regulation,
Material composition
709

16

Contains Nonbinding Recommendations
Draft - Not for Implementation

710

Table 3. Physician or Dentist-Centric Devices - Summary of Physician, Dentist and Device Information
Physician
name, degree
and address

Date(s) of
procedures

Description of special need
necessitating custom device

Custom device name or
custom device components

Other relevant information

Product name,
Brand name,
Product model number,
Product catalog number,
Other product identifier
information,
Product code,
Product classification
regulation,
Material composition

711

17

Contains Nonbinding Recommendations
Draft - Not for Implementation

Appendix II

712

713
714

Custom Device Annual Report Truthful And Accurate
Statement

715
716

I certify that, in my capacity as (the position held in company) of

717

(company name), I believe to the best of my knowledge, that all data

718

and information submitted in the custom device annual report are truthful and

719
720
721

accurate and that no material fact has been omitted.

722

_____________________________

723

(Signature)

724

______________________________

725

(Typed Name)

726

______________________________

727

(Date)

728
729
730
731
732
733
734
735

18

Contains Nonbinding Recommendations
Draft - Not for Implementation
736
737
738
739

Appendix III
Custom Device Decision Tree
Note the term physician in the decision tree stands for physician, dentist or specially
qualified person as noted in Section 520(b) of the FD&C Act.
740

19