Accessory classification de novo request

Medical Device Accessories –
Describing Accessories and
Classification Pathways
Guidance for Industry and
Food and Drug Administration Staff
Document issued on December 20, 2017.
Document originally issued on December 30, 2016.
This document supersedes Medical Device Accessories – Describing
Accessories and Classification Pathway for New Accessory Types, issued
January 30, 2017.
An agency may not conduct or sponsor, and a person is not required to respond to, a
collection of information unless it displays a currently valid OMB control number.
The OMB control number for this information collection is 0910-0823 (expires 09-302019).
See additional PRA statement in Section VII of the guidance.
For questions about this document regarding CDRH-regulated devices, contact the Office of the
Center Director at (301) 796-6900 or by email at [email protected].
For questions about this document regarding CBER-regulated devices, contact CBER’s Office of
Communication, Outreach and Development (OCOD) at 1-800-835-4709 or 240-402-8010 or by
email at [email protected].

U.S. Department of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health
Center for Biologics Evaluation and Research

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Preface
Public Comment
You may submit electronic comments and suggestions at any time for Agency consideration to
https://www.regulations.gov. Submit written comments to the Division of Dockets Management,
Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD
20852.
Identify all comments with the docket number FDA-2015-D-0025. Comments may not be acted
upon by the Agency until the document is next revised or updated.

Additional Copies
CDRH
Additional copies are available from the Internet. You may also send an e-mail request to
to receive a copy of the guidance. Please use the document number 1770 to identify the
guidance you are requesting.
CBER
Additional copies are available from the Center for Biologics Evaluation and Research (CBER),
Office of Communication, Outreach, and Development (OCOD), 10903 New Hampshire Ave.,
WO71, Room 3128, Silver Spring, MD 20903, or by calling 1-800-835-4709 or 240-402-8010,
by email, [email protected], or from the Internet at
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guida
nces/default.htm.

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Table of Contents
I.

INTRODUCTION ........................................................................................................ 1

II.

BACKGROUND .......................................................................................................... 2

III.

SCOPE .......................................................................................................................... 4

IV.

DEFINITIONS .............................................................................................................. 5

V.

ACCESSORY CLASSIFICATION POLICY .............................................................. 6

A.

Is the article an accessory? ...........................................................................................6

B.
What are the risks of the accessory when used as intended with the parent device(s)
and what regulatory controls are necessary to provide a reasonable assurance of its safety
and effectiveness? ..................................................................................................................8
VI.

ACCESSORY CLASSIFICATION PROCESSES....................................................... 8

A.

Accessory Requests ......................................................................................................8

B.

Classification of New Accessory Types through the De Novo Process .....................11

VII.

PAPERWORK REDUCTION ACT OF 1995............................................................ 12

APPENDIX 1 – REQUEST FOR ACCESSORY DE NOVO CLASSIFICATION .............. 13

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Medical Device Accessories –
Describing Accessories and
Classification Pathways
Guidance for Industry and
Food and Drug Administration Staff
This guidance represents the current thinking of the Food and Drug Administration (FDA
or Agency) on this topic. It does not establish any rights for any person and is not binding
on FDA or the public. You can use an alternative approach if it satisfies the requirements
of the applicable statutes and regulations. To discuss an alternative approach, contact the
FDA staff or Office responsible for this guidance as listed on the title page.

I.

Introduction  

The Food and Drug Administration (FDA) developed this document to provide guidance to
industry and FDA staff about the regulation of accessories to medical devices. This guidance is
intended to describe FDA’s policy concerning the classification of accessories and to discuss the
application of this policy to devices that are commonly used as accessories to other medical
devices. In addition, this guidance explains what devices FDA generally considers an
“accessory” and describes the processes under Section 513(f)(6) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) to allow requests for risk- and regulatory control-based classification
of accessories.
The 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.
Throughout this guidance document, the terms “we,” “us” and “our” refer to FDA staff from the
Center for Devices and Radiological Health (CDRH) or the Center for Biologics Evaluation and
Research (CBER) involved in the review and decision-making aspects of the accessory
classification process. “You” and “your” refer to the submitter of an accessory request, De Novo,
and/or other related materials.

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II. Background 
FDA has jurisdiction over accessories because the definition of the term “device” provided in
Section 201(h) of the FD&C Act defines “device” to include, among other products, an
“accessory”:
The term “device” means an instrument, apparatus, implement, machine, contrivance,
implant, in vitro reagent, or other similar or related article, including any component,
part, or accessory, which is –
(1) recognized in the official National Formulary, or the United States Pharmacopeia,
or any supplement to them;
(2) intended for use in the diagnosis of disease or other conditions, or in the cure,
mitigation, treatment, or prevention of disease, in man or other animals, or
(3) intended to affect the structure or any function of the body of man or other
animals, and
which does not achieve its primary intended purposes through chemical action within or
on the body of man or other animals and which is not dependent upon being metabolized
for the achievement of its primary intended purposes.
All articles, including accessories, that meet the definition of “device” above are regulated under
the FD&C Act. Accordingly, this guidance describes the types of devices that FDA generally
considers as accessories and discusses the risk- and regulatory control-based classification
paradigm for these accessories. This information is expected to provide a greater level of
transparency with regards to the classification of accessories and will aid FDA staff and industry
in assuring that these devices are subject to the appropriate level of regulatory oversight by FDA.
FDA has traditionally determined the classification of device accessory types in one of two
ways:
·

First, by inclusion in the same classification as the parent device, which can be:
o (1) Through operation of 510(k) Premarket Notification clearance. In this case,
the name of the classification regulation identifies only the parent device.
However, FDA, through the 510(k) submission, may find accessories to the parent
device to be substantially equivalent to either a predicate parent device with the
same intended use and technological characteristics, or different technological
characteristics that do not raise different questions of safety and effectiveness, or
a predicate accessory that has previously been cleared under the parent device’s
classification regulation with the same intended use and technological
characteristics, or different technological characteristics that do not raise different
questions of safety and effectiveness. These accessories would thus be classified
within the same classification as the parent device. Similarly, when the parent
device classification regulation identifies only certain accessories, FDA may
determine additional accessories to be classified under the regulation through the

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submission of a 510(k) by the sponsor demonstrating substantial equivalence of
the parent device with new accessories to the parent device with the predicate
accessories.
o

(2) Through operation of Premarket Application (PMA) approval. Accessories
to an approved Class III device may also be approved in a PMA, in which case
they would remain in Class III along with the parent device; or

o (3) By express inclusion in the classification regulation1 or reclassification order2
for the parent device. In this case, the title of the classification regulation
specifically cites the name of the parent device type and the corresponding
accessories. These classification regulations or orders typically place accessories
in the same risk- and regulatory control-based classification (e.g., Class I, II, or
III) as the parent device but sometimes classify accessories into a different riskand regulatory control-based classification.
·

Second, by issuance of a unique, separate classification regulation for the accessory. In
this case, FDA has determined that a classification regulation for an accessory should be
separate from that of the corresponding parent device. This type of classification has
traditionally been considered for accessory types that may be used with multiple parent
devices or that have unique standalone functions. In accordance with this second way,
FDA may consider issuing a separate classification regulation for a specific category of
accessories that has been identified as having a different risk profile from that of the
parent device and thus requires a different level of regulatory controls to provide
reasonable assurance of safety and effectiveness of the accessories.

On August 18, 2017, section 513(f) of the FD&C Act was amended by the FDA Reauthorization
Act of 2017 (Pub. L. 115-52) to state that “the Secretary shall … classify an accessory under
[section 513] based on the risks of the accessory when used as intended and the level of
regulatory controls necessary to provide a reasonable assurance of safety and effectiveness of the
accessory, notwithstanding the classification of any other device with which such accessory is
intended to be used.” Accordingly, the classification of accessory devices, as for non-accessory
devices, should reflect the risks of the device when used as intended and the level of regulatory
controls necessary to provide a reasonable assurance of safety and effectiveness. Classifying an
accessory in the same class as its parent device is appropriate when the accessory, when used as
intended with the parent device, meets the criteria for placement in the class of the parent device.
However, some accessories can have a lower risk profile than that of their parent device and,
therefore, may warrant being regulated in a lower class. For example, an accessory to a class III
parent device may pose lower risk that could be mitigated through general controls or general
and special controls and thus could be regulated as class I or class II.

1

See section 513(d) of the FD&C Act, 21 U.S.C. 360c(d).
Two reclassification processes are described in sections 513(e) and 513(f)(3) of the FD&C Act, 21 U.S.C. 360c(e)
and (f)(3). Prior to the Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA), FDA
reclassified devices under section 513(e) of the FD&C Act (21 U.S.C. 360c(e)) through rulemaking; FDASIA
changed this to an order process.
2

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III. Scope 
This guidance document describes what FDA generally considers an “accessory” and how the
FD&C Act’s risk- and regulatory control-based framework for classification applies to
accessories to other medical devices. In this guidance, we describe considerations for
determining applicable risk to all articles that meet the definition of an accessory. This guidance
is only applicable to articles that meet the definition of a device under section 201(h) of the
FD&C Act.
In addition, this guidance describes use of the Accessory Classification processes under section
513(f)(6) of the FD&C Act, which provides mechanisms for requesting the appropriate
classification (or reclassification) of –
·

·

an accessory that is “included in an application for premarket approval … under section
515 or a report under section 510(k) for clearance of such device [intended to be used
with the accessory] and the Secretary has not classified such accessory distinctly from
another device,”3 and
an accessory “that [has] been granted marketing authorization as part of a submission for
another device with which the accessory involved is intended to be used, through an
application for such other device under section 515(c), a report under section 510(k), or a
request for classification under [513(f)(2)] …”4

While other mechanisms exist to request the appropriate classification of an accessory, this
guidance focuses on the Accessory Classification process described in section 513(f)(6) of the
FD&C Act. For example, for a new accessory type (i.e., an accessory of a type that has not been
previously classified under the FD&C Act, cleared for marketing under a 510(k) submission, or
approved in a PMA), the De Novo classification process under section 513(f)(2) may be used to
obtain classification of such an accessory.5 In addition, manufacturers of accessories within an
accessory type that has already been classified by regulation or order, or has received PMA
approval or 510(k) clearance, may seek reclassification6 or exemption from the requirement to
submit a 510(k) notification7 under applicable sections of the FD&C Act.
FDA intends for the risk- and regulatory control-based classification paradigm discussed in this
guidance to apply to all software products that meet the definition of an accessory, including
those that may also meet the definition of “Software as a Medical Device (SaMD).”
As part of the FDA’s efforts for international convergence, the International Medical Device
Regulators Forum (IMDRF) adopted the definition of SaMD as “software intended to be used for

3

See section 513(f)(6)(C)(i) of the FD&C Act.
See section 513(f)(6)(D) of the FD&C Act.
5
See section 513(f)(6)(E) of the FD&C Act.
6
See sections 513(e) and 513(f)(3) of the FD&C Act.
7
See section 510(m) of the FD&C Act.
4

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one or more medical purposes that perform these purposes without being part of a hardware
medical device.” 8
SaMD that meets the definition of a device under the FD&C Act is regulated by FDA. However,
SaMD that meets this device definition and uses data from a medical device does not
automatically become an accessory for purposes of this guidance. For example, a stand-alone
software program that is intended to analyze radiological images or analyzes specific data
parameters generated by a device (e.g., blood pressure data or heart rate data) is considered a
SaMD but would not be considered to support, supplement, and/or augment the performance of
the device that generated data, and therefore, would not be an accessory.
In some cases, software that meets the definition of SaMD may be used in combination (e.g., as a
module) with other devices. In these cases, the SaMD may also be considered an accessory if it
supports, supplements, and/or augments the performance of one or more parent devices, as
described in Section IV below.
Regardless of whether a SaMD uses data from other devices or is used in combination with other
devices, the FDA intends to apply the same risk- and regulatory control-based classification
paradigm discussed in this guidance to all software products that meet the definition of SaMD
and also meet the definition of an accessory.

IV. Definitions 
Accessory: A finished device that is intended to support, supplement, and/or augment the
performance of one or more parent devices.
Component (21 CFR 820.3(c)): “[A]ny raw material, substance, piece, part, software,
firmware, labeling, or assembly which is intended to be included as part of the finished,
packaged, and labeled device.”
Finished Device (21 CFR 820.3(l)): “[A]ny device or accessory to any device that is suitable for
use or capable of functioning, whether or not it is packaged, labeled, or sterilized.”9
Parent Device: A finished device whose performance is supported, supplemented, and/or
augmented by one or more accessories.

8

See IMDRF SaMD WG/N10 Final: Software as a Medical Device: Key Definitions
(http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-131209-samd-key-definitions-140901.pdf)
9
Note that the preamble to the Quality System Final Rule (61 FR 52609, October 7, 1996) states “To better clarify
its intent, FDA has amended the definition to add that all devices that are capable of functioning, including those
devices that could be used even though they are not yet in their final form, are ‘finished devices.’ For example,
devices that have been manufactured or assembled, and need only to be sterilized, polished, inspected and tested, or
packaged or labeled by a purchaser/manufacturer are clearly not components, but are now in a condition in which
they could be used, therefore meeting the definition of ‘finished device.’”

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V.

Accessory Classification Policy 

The policy governing the classification of accessories is subject to the same risk- and regulatory
control-based scheme under the FD&C Act that FDA uses to classify all medical devices. The
risks of an accessory are the risks that it presents when used with the corresponding parent
device as intended. In order to classify an accessory, FDA addresses the following two
questions:
1. Is the article an accessory?
2. What is the risk of the accessory when used as intended with the parent device(s) and
what regulatory controls are necessary to provide a reasonable assurance of its safety and
effectiveness?
The answers to these two questions inform the risk- and regulatory control-based classification
of a potential accessory pursuant to the criteria at section 513(a)(1) of the FD&C Act. Individual
accessories may either be classified pursuant to the same regulation as a corresponding parent
device, when appropriate, or be regulated independently. The following subsections provide
further details and considerations regarding the risk- and regulatory control-based classification
for accessories.

A.

Is the article an accessory?

The accessory classification process begins with the analysis of whether the article under
consideration is an accessory as described in this guidance document. We consider an
accessory as an article that:
1. Is intended for use with one or more parent devices.
FDA expects that whether an article is intended for use with a parent device
will generally be determined by the labeling and promotional materials for the
potential accessory device (rather than by the labeling and promotional
materials for the parent device). If labeling, promotional materials, or other
evidence of intended use demonstrates that an article is intended for use with a
parent device (either a particular brand or a device type), and it supports,
supplements, and/or augments that device, FDA generally considers the article
to be an accessory and, thus, a “device” as defined in section 201(h) of the
FD&C Act. This includes those articles labeled as being “optional”.
It is important to note that FDA does not generally consider articles that do
not meet the definition of an accessory as accessories simply because they
may be used in conjunction with a device. For example, FDA would
generally not consider a mobile phone that is used as a general platform for
applications that include mobile medical applications that are medical devices
or an off-the-shelf computer monitor used to display medical data as
accessories unless they are specifically intended for use with such medical
devices.
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2. Is intended to support, supplement, and/or augment the

performance of one or more parent devices.
A device supports the performance of a parent device by enabling or
facilitating that device to perform according to its intended use. For example,
a tunneling tool for a neurostimulation device that is intended to create a
conduit for the leads between the target location to the neurostimulator
supports the neurostimulator by facilitating it to provide stimulation to the
target neural tissue. In this case, the accessory is necessary to enable the
parent device to meet its intended use. An infusion pump stand also supports
the intended use of a parent device (an infusion pump) by holding medications
or liquids and other infusion accessories firmly, at an appropriate height, and
in convenient reach of the patient or caregiver. In this case, the parent device
can perform its intended use without the accessory, but the accessory
nonetheless supports the performance of the device.
A device supplements the performance of a parent device if it adds a new
function or a new way of using the parent device, without changing the
intended use of the parent device. For example, a pulse oximeter allows a
multi-parameter monitor to display oxygen saturation but does not change its
intended use, which is to record and display multiple physiological
parameters. Similarly, a new balloon catheter used to insert an already
approved transcatheter heart valve into a smaller diseased artery supplements
the parent device’s intended use. The balloon catheter supplements the
intended use of the transcatheter heart valve by expanding the population of
patients who can receive the parent device to those with smaller diameter
arteries, such as women.
A device augments the performance of a parent device by enabling the device
to perform its intended use more safely or effectively. Augments includes
improving the performance of a parent device by enabling it to perform more
quickly or improving usability or convenience for the device user. For
example, a guidewire augments the performance of a bone-cutting instrument
by increasing precision of the parent device and reducing the risk to the
patient. Similarly, a software program that adds color or contrast filters to
enhance raw images generated by an imaging device augments the
performance of a parent device by enabling it to perform more effectively.
In practice, the distinctions among devices that support, supplement, or
augment parent devices are subtle and many devices that meet the definition
of an accessory may do more than one of these things. Thus, if the device is
intended to support, supplement, and/or augment the performance of one or
more parent devices, we intend to consider the device to be an accessory
whether it is required or optional..
Some products that are not specifically intended for use, but nevertheless may

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be used, with a medical device and which do not meet the definition of an
accessory may not warrant independent classification if they are not devices
under Section 201(h) of the FD&C Act. As an example, non-device-specific
off-the-shelf replacement parts (e.g., batteries, USB cables, computer mouse,
etc.) may be used with a medical device, but FDA does not intend to consider
these products to be accessories or medical devices.

B.

What are the risks of the accessory when used as intended
with the parent device(s) and what regulatory controls
are necessary to provide a reasonable assurance of its
safety and effectiveness?

Under the policy described in this guidance, FDA intends to determine the risk of
accessories and the regulatory controls necessary to provide a reasonable assurance of
their safety and effectiveness according to their intended use in the same manner that is
used to determine such for devices that are not accessories. Because accessories are
intended to be used with and to support, supplement, and/or augment one or more parent
devices, FDA intends to determine the risks of accessories when used, as intended, with
the parent device type.
Determining the risks of accessories according to their use with parent devices does not
mean that all risks of a parent device are imputed to the accessory; the risk profile of an
accessory can differ significantly from that of the parent device, warranting differences in
regulatory classification. In determining the classification of an accessory, FDA intends
to evaluate the risks imposed by the accessory’s impact on the parent device and any
unique risks of the accessory independent of its parent device. As with the classification
of any other device, the types of regulatory controls necessary to control these risks of the
use of the accessory device with the parent device will determine the regulatory class for
accessories.

VI. Accessory Classification Processes 
A.

Accessory Requests

The appropriate classification or reclassification of a legally-marketed accessory or a new
accessory type can be requested under section 513(f)(6) of the FD&C Act through the
Accessory Request types described below. Note that FDA intends to track Accessory
Requests as Q-Submissions.
For devices regulated by CDRH, Accessory Requests should be submitted to:
U.S. Food and Drug Administration
Center for Devices and Radiological Health
Document Control Center – WO66-G609

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10903 New Hampshire Ave
Silver Spring, Maryland 20993-0002
For devices regulated by CBER, Accessory Requests should be submitted to:
U.S. Food and Drug Administration
Center for Biologics Evaluation and Research
Document Control Center
10903 New Hampshire Ave.
WO71-G112
Silver Spring, Maryland 20993-0002

1. New Accessory Type
In accordance with section 513(f)(6)(C) of the FD&C Act, you may submit an
Accessory Request for appropriate classification of an accessory that is included
in a PMA, PMA supplement, or 510(k), if the accessory has not been classified
distinctly from another device. This New Accessory Request is appropriate for an
accessory of a type that has not been previously classified under the FD&C Act,
cleared for marketing under a 510(k) submission, or approved in a PMA. This
request should be submitted together with the parent device submission and
include a cover letter that clearly identifies that the submission includes a “New
Accessory Request.” The proposed classification of the accessory (i.e., class I or
class II) should also be clearly identified in the cover letter and/or the request. In
addition, the request should provide the necessary information, based on Least
Burdensome principles, to establish the risk profile of the accessory when used as
intended with the parent device as described in section V.B. above. Note that
requests for classification of an accessory in class II must include an initial draft
proposal for special controls, if special controls would be required pursuant to
subsection 513(a)(1)(B) of the FD&C Act.10
Since a Pre-Submission is appropriate when FDA’s feedback on specific
questions is necessary to guide product development and/or application
preparation, we recommend that you submit a Pre-Submission to request feedback
on a proposed Accessory Request. For more information, see “Requests for
Feedback on Medical Device Submissions: The Pre-Submission Program and
Meetings with Food and Drug Administration Staff - Guidance for Industry and
Food and Drug Administration Staff”
(https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/
GuidanceDocuments/UCM311176.pdf).
FDA must grant or deny the New Accessory Request concurrently with the
decision on the premarket submission with which the request was submitted.11 If
the New Accessory Request is granted, we will issue you an order establishing a
new classification for such accessory for the specified intended use or uses of
10
11

See section 513(f)(6)(C)(i)(III) of the FD&C Act.
See section 513(f)(6)(C)(ii) of the FD&C Act.

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such accessory and for any accessory with the same intended use or uses as such
accessory. Effective on the date of the granting order, the requester may
immediately begin marketing the device subject to the general controls and any
identified special controls. If the New Accessory Request is denied but the
premarket submission with which it was submitted is cleared or approved, the
accessory may be legally marketed but will be considered to be in the same
classification as the parent device.

2. Existing Accessory Type
In accordance with section 513(f)(6)(D) of the FD&C Act, you may submit an
Accessory Request for appropriate classification of an accessory that has been
granted marketing authorization as part of a submission for another device with
which the accessory involved is intended to be used, through a premarket
submission or a De Novo request for such other device (referred to as an
“Existing Accessory Type”). The Accessory Request should include a cover
letter that clearly identifies that the submission is an “Existing Accessory
Request.” The proposed classification of the accessory (i.e., class I or class II), as
well as the current classification, should also be clearly identified in the cover
letter and/or the request. An Existing Accessory Request should include the
necessary information, based on Least Burdensome principles, to establish the
risk profile of the accessory when used as intended with the identified parent
device as described in section V.B. above. Note that requests for classification of
an accessory in class II must include an initial draft proposal for special controls,
if special controls would be required pursuant to subsection 513(a)(1)(B) of the
FD&C Act.12 Prior to the submission of an Existing Accessory Request, FDA
will provide an opportunity for a meeting to discuss the appropriate classification
of the accessory, upon request. 13
Since a Pre-Submission is appropriate when FDA’s feedback on specific
questions is necessary to guide product development and/or application
preparation, we recommend that you submit a Pre-Submission to request feedback
on a proposed Accessory Request. For more information, see “Requests for
Feedback on Medical Device Submissions: The Pre-Submission Program and
Meetings with Food and Drug Administration Staff - Guidance for Industry and
Food and Drug Administration Staff”
(https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/
GuidanceDocuments/UCM311176.pdf)
FDA must grant or deny the Accessory Request for an Existing Accessory Type
within 85 days of receiving the request.14 If the request is granted, we will issue
you a written order granting the Accessory Request and identifying the
classification of the device (either class I or class II). We will then publish a final
12

See section 513(f)(6)(D)(ii) of the FD&C Act.
See section 513(f)(6)(D)(ii) of the FD&C Act.
14
See section 513(f)(6)(D)(iii) of the FD&C Act.
13

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order in the Federal Register providing public notice of the decision, which will
result in codification of the device’s identification, classification, and applicable
requirements in Title 21 of the Code of Federal Regulations (device
classifications are at parts 862 – 892). If FDA does not agree with the
recommendation for classification submitted in the request, we will provide a
written response that includes a detailed description and justification for the
denial of the request.

B.

Classification of New Accessory Types through the De
Novo Process

In addition to the Accessory Requests under Section 513(f)(6), you can utilize the De
Novo classification process in Section 513(f)(2) of the FD&C Act to request risk- and
regulatory control-based classifications of new accessory types. In order to be considered
a new accessory type, the accessory under consideration should not be classified by an
existing classification regulation and should not be the subject of any approved PMAs or
cleared 510(k)s for that accessory type. This De Novo classification process provides a
pathway to class I or class II classification for accessories with low to moderate risk for
which general controls or general and special controls provide a reasonable assurance of
safety and effectiveness, but for which there are no legally marketed predicate devices.
For additional information regarding the De Novo classification process, please see “De
Novo Classification Process (Evaluation of Automatic Class III Designation); Guidance
for Industry and Food and Drug Administration Staff”
(https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddevgen/documents/document/ucm080197.pdf). Please also refer to Appendix 1 (below) for
the information FDA recommends be submitted in a De Novo request for a new
accessory type.
FDA must make a classification determination for the device that is the subject of the De
Novo request by written order within 120 days of the request.15 If the submitter
demonstrates that the criteria in section 513(a)(1)(A) or (B) of the FD&C Act are met
(i.e., accessories for which general controls or general and special controls provide a
reasonable assurance of safety and effectiveness), FDA will grant the De Novo request,
which classifies the new accessory (and accessory type) in class I or class II. The
accessory may then be marketed immediately and serve as a predicate device for future
510(k) premarket notifications, if applicable. FDA will publish a notice in the Federal
Register announcing the classification and the regulatory controls necessary to provide
reasonable assurance of safety and effectiveness of the accessory. If the request to
undertake De Novo classification is declined,16 the accessory remains in class III under
15

See section 513(f)(2)(A)(iii) of the FD&C Act.
A request to undertake the De Novo classification could be declined for reasons including if the performance data
provided in the De Novo request do not support that general controls or general and special controls can
appropriately mitigate identified risks to health for the device to provide a reasonable assurance of safety and
effectiveness.
16

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section 513(f)(1) of the FD&C Act and may not be marketed until a PMA is submitted by
the sponsor and approved by FDA.

VII. Paperwork Reduction Act of 1995 
This guidance contains information collection provisions that are subject to review by the Office
of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C.
3501-3520).
The time required to complete this information collection is estimated to average 180 hours per
response, including the time to review instructions, search existing data sources, gather the data
needed, and complete and review the information collection. Send comments regarding this
burden estimate to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
[email protected]
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB control number. The OMB control number
for this information collection is 0910-0823 (expires 09-30-2019).

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Contains Nonbinding Recommendations

Appendix 1 – Request for Accessory De Novo Classification 
Manufacturers or other interested parties may seek a decision by the FDA on the appropriate
risk- and regulatory control-based classification of a new type of accessory by filing a De Novo
request (hereafter a “De Novo”) under section 513(f)(2) of the FD&C Act. This process is also
known as the De Novo classification process.17
In order to streamline the submission and evaluation of the accessory De Novo so that only
information necessary to assess accessory safety and effectiveness is submitted and reviewed, we
recommend that the following information be provided:
·
·

·
·

·
·

·

Clear identification as a De Novo request for a new accessory device type;
Device Information and Summary:
§ A description of the relevant parent device(s);
§ A description of the ability for the accessory to be compatible with a specific
parent device, multiple parent devices, or a class of devices;
§ A description of the technical characteristics of the accessory, which ensure
compatibility with a specific parent device, multiple parent devices, or a class
of devices;
§ A description of how the accessory supports, supplements and/or augments
the performance of the parent device.
Identification of parent product(s) to which the accessory is compatible, including
model number, connector type, etc.;
Classification summary and recommendation:
§ The classification summary should include a rationale for why the accessory
device does not fit within any identified classification for the parent device(s);
An identification of the risks to health presented by the accessory device and
proposed mitigation measures;
Proposed controls:
§ For proposed class II devices, a list of general and special controls that
sufficiently mitigate the risks to health, including compatibility of the
accessory device with the parent device and a description of how the proposed
special controls will provide a reasonable assurance of safety and
effectiveness for the accessory device
§ For proposed class I devices, an identification of how the application of
general controls only would sufficiently mitigate the risks to health and would
provide a reasonable assurance of safety and effectiveness of the accessory
device;
Summary of the performance data supporting the De Novo:
§ Reference to all reasonably known relevant data and information, including
new information, about the accessory device and/or the accessory in

17

See “De Novo Classification Process (Evaluation of Automatic Class III Designation); Guidance for Industry and
Food and Drug Administration Staff” (https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddevgen/documents/document/ucm080197.pdf).

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Contains Nonbinding Recommendations

·

combination with the parent device(s), whether favorable or unfavorable to
the proposed classification; and
Labeling for the accessory with adequate instructions for use with the parent
device(s):
§ Include labeling instructions to address compatibility of the new accessory
device and the parent device(s), including any relevant performance data to
support compatibility; and
§ Include relevant technical characteristics of the accessory.

In preparing a De Novo request for an accessory of a new type, we suggest you review
publicly posted information, including decision summary documents, for recently granted
CDRH De Novo requests available on our website at
http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/
CDRHTransparency/ucm232269.htm.
In an effort to further streamline and facilitate FDA’s review of your accessory De Novo
classification request, we recommend that you provide a draft executive summary document
with the following information:
·
·
·

·
·

·

Administrative information,
Proposed identification language for a new classification regulation or order;
Summary of the accessory device, including a detailed description of the
accessory, including any necessary technical characteristics and compatibility
information with the parent device(s);
Summary of the performance data to support the proposed classification
recommendation;
Risk and Mitigation Information: for class I accessory devices, an explanation
of how general controls adequately mitigate any risks to health; for class II
accessory devices, listing of the risks and mitigation measures, including the
special controls necessary to mitigate the risks to health; and
Benefit/Risk Considerations.18

18

For information on benefit-risk determinations and factors considered, please see FDA guidance titled “Guidance
for Industry and Food and Drug Administration Staff - Factors to Consider When Making Benefit-Risk
Determinations in Medical Device Premarket Approval and De Novo Classifications,” available at
https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM517504
.pdf.

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