Medical Device Reporting

Forms and Documents

Document Name	Status

No forms / supporting documents in this ICR. Check IC Document Collections.

IC Document Collections

IC ID	Document Title	Status
6116	Manufacturer Reporting Other-Agency Guidance	Modified
231473	Voluntary Malfunction Summary Reporting Program	Modified
202637	Importer Reporting, Death and Serious Injury - Third-Party	Modified
202636	MDR Files	Modified
202635	MDR Procedures	Modified
202634	Supplemental Reports	Modified
202633	Importer Reporting, Death and Serious Injury - Reporting	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: 202107-0910-003
Status: Received in OIRA	Previous ICR Reference No: 201805-0910-006
Agency/Subagency: HHS/FDA	Agency Tracking No: CDRH
Title: Medical Device Reporting
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 07/29/2021

	Requested	Previously Approved
Expiration Date	36 Months From Approved	08/31/2021
Responses	2,130,285	563,827
Time Burden (Hours)	223,338	67,978
Cost Burden (Dollars)	0	0

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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.

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

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking
	Other Documents for OIRA Review

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	86 FR 22671	04/29/2021
30-day Notice:	Federal Register Citation:	Citation Date:
	86 FR 40593	07/28/2021
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 10

IC Title	Form No.	Form Name
Exemptions
Importer Reporting, Death and Serious Injury - Reporting
Importer Reporting, Death and Serious Injury - Third-Party
MDR Files
MDR Procedures
Manufacturer Reporting
Supplemental Reports
User Facility Annual Reporting FDA Form 3419	Form FDA 3419	User Facility Annual Report Form
User Facility Reporting
Voluntary Malfunction Summary Reporting Program

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ICR Summary of Burden

	Total Request	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	2,130,285	563,827	0	0	1,566,458	0
Annual Time Burden (Hours)	223,338	67,978	0	0	155,360	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: This information collection has been adjusted. There has been an increase of 155,360 total burden hours and a corresponding increase of 1,566,458 total annual responses. This increase corresponds with data obtained from our database. In June 2019, the FDA formally ended the Alternative Summary Reporting (ASR) Program and revoked all such exemptions. As a result, manufacturers for which ASR's exemptions were revoked were then required to start submitting individual reports for each device associated event. This has resulted in an increase of the number of submissions.

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Annual Cost to Federal Government: $7,109,802

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

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     Yes

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     Yes

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? No

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Common Form ICR:  No

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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: 07/29/2021

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