Medical Devices; Medical Device Reporting; Manufacturer Reporting; Importer Reporting, User Facility Reporting, Distributor Reporting

Forms and Documents

Document	Type	Status	Availability
Form 3419 User Facility Annual Reporting FDA Form 3419	Form and Instruction	Modified	Available
eMDR--ICR SS--07-28-15.doc	Supporting Statement A	Uploaded 2015-07-31	Repair queued

IC Document Collections

IC ID	Collection	Type	Status	Form
6116	Manufacturer Reporting		Modified
202637	Importer Reporting, Death and Serious Injury		Modified
202636	MDR Files		Modified
202635	MDR Procedures		Modified
202634	Supplemental Reports		Modified
202633	Importer Reporting, Death and Serious Injury		Modified
202632	User Facility Annual Reporting FDA Form 3419	Form and Instruction	Modified
202631	User Facility Reporting		Modified
202630	Exemptions		Modified

ICR Details

OMB Control No: 0910-0437	ICR Reference No: 201507-0910-011
Status: Historical Active	Previous ICR Reference No: 201206-0910-003
Agency/Subagency: HHS/FDA	Agency Tracking No: CDRH
Title: Medical Devices; Medical Device Reporting; Manufacturer Reporting; Importer Reporting, User Facility Reporting, Distributor Reporting
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 08/27/2015
	Date Received in OIRA: 08/03/2015
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2018	36 Months From Approved	08/31/2015
Responses	361,185	0	374,090
Time Burden (Hours)	46,446	0	391,526
Cost Burden (Dollars)	0	0	0

---

Abstract: This ICR collects information from medical device manufacturers, importers, and user facilities that are required to submit electronic and paper medical device reports (MDRs) to the Food and Drug Administration (FDA) and to maintain records, and who may also seek exemption from these requirements. The information that is obtained from these reports will be used to evaluate risks associated with medical devices and enable FDA to take appropriate regulatory measures to protect the public health. Complete, accurate, and timely adverse event information is necessary for the identification of emerging device problems so the Agency can protect the public health under the FD&C Act.

---

Authorizing Statute(s): US Code: 21 USC 360i(a)(b)(c) Name of Law: FFDCA
  

Citations for New Statutory Requirements: None

---

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0910-AF86	Final or interim final rulemaking	79 FR 8832	02/14/2015

---

Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? No

---

Number of Information Collection (IC) in this ICR: 9

IC Title	Form No.	Form Name
Manufacturer Reporting
Exemptions
User Facility Reporting
User Facility Annual Reporting FDA Form 3419	3419	User Facility Annual Report Form
Importer Reporting, Death and Serious Injury
Supplemental Reports
MDR Procedures
MDR Files
Importer Reporting, Death and Serious Injury

---

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	361,185	374,090	0	-12,905	0	0
Annual Time Burden (Hours)	46,446	391,526	0	-345,080	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Changing Regulations

Burden decreases because of Program Change due to Agency Discretion: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: This is a new information collection.

---

Annual Cost to Federal Government: $5,660,064

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Uncollected

---

Common Form ICR:  No

---

On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 08/03/2015

---