Medical Device Reporting

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability

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

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
6116	Manufacturer Reporting		Modified
231473	Voluntary Malfunction Summary Reporting Program		New
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		Modified
202631	User Facility Reporting		Modified
202630	Exemptions		Modified

ICR Details

OMB Control No: 0910-0437	ICR Reference No: 201805-0910-006
Status: Active	Previous ICR Reference No: 201508-0910-002
Agency/Subagency: HHS/FDA	Agency Tracking No: CDRH
Title: Medical Device Reporting
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 08/08/2018
	Date Received in OIRA: 06/21/2018
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2021	36 Months From Approved	12/31/2018
Responses	563,827	0	361,185
Time Burden (Hours)	67,978	0	46,446
Cost Burden (Dollars)	0	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:
	82 FR 60922	12/26/2017
30-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 26694	06/08/2018
Did the Agency receive public comments on this ICR? Yes

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

table that charts list of burden

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

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ICR Summary of Burden

table that charts list 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	563,827	361,185	0	0	202,642	0
Annual Time Burden (Hours)	67,978	46,446	0	0	21,532	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: We request revision of this ICR to add the reporting burden for the proposed Voluntary Malfunction Summary Report Program and to make the resulting revisions to the estimated burdens for Manufacturer Reporting and Supplemental Reporting, respectively. The adjustments to update the estimates based on CY 2016 data and the proposed revisions to OMB control number 0910-0437 together would increase the total estimated reporting burden by 21,532 hours.

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Annual Cost to Federal Government: $7,894,341

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? Uncollected

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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: 06/21/2018

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