Premarket Approval of Medical Devices - 21 CFR Part 814

Forms and Documents

Document Name	Status
0231 ss 3-19-2020.docx Supporting Statement A	2020-03-20

IC Document Collections

IC ID	Document Title	Status
5826	Premarket Approval of Medical Devices Reporting Requirements	Modified
209459	Premarket Approval of Medical Devices Maintenance of Records	Modified

ICR Details

OMB Control No: 0910-0231	ICR Reference No: 202001-0910-010
Status: Active	Previous ICR Reference No: 201912-0910-005
Agency/Subagency: HHS/FDA	Agency Tracking No: CDRH
Title: Premarket Approval of Medical Devices - 21 CFR Part 814
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 03/25/2020
	Date Received in OIRA: 03/20/2020
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2023	36 Months From Approved	03/31/2020
Responses	5,542	0	5,268
Time Burden (Hours)	392,518	0	357,736
Cost Burden (Dollars)	0	0	0

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Abstract: This ICR collects information from persons filing a PMA application or a PMA supplement with FDA for approval of certain class III medical devices. The PMA regulation establishes procedures that FDA utilizes in approving, denying, or withdrawing approval of any PMA. It provides specific, clear, and flexible instructions to applicants so those respondents know what information is required in a PMA. PMA supplements are also used by FDA to determine any additional action the agency must take to protect the public health. The data reported to FDA and the records that are maintained allow FDA and industry to make decisions and take actions to protect the public health from defective medical devices.

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Authorizing Statute(s): US Code: 21 USC 360(e) Name of Law: FFDCA
   US Code: 21 USC 351(f) 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

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 57030	10/24/2019
30-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 7311	02/07/2020
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 2

IC Title	Form No.	Form Name
Premarket Approval of Medical Devices Reporting Requirements
Premarket Approval of Medical Devices Maintenance of Records

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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	5,542	5,268	0	0	274	0
Annual Time Burden (Hours)	392,518	357,736	0	0	34,782	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: The following changes resulted in an adjustment in an overall total burden increase of 34,782 hours. -Added the burden estimate for “Information on clinical investigations conducted outside the United States (§ 814.20(b)(6)(ii)(C)),” which is associated with the “Human Subject Protection; Acceptance of Data from Clinical Investigations for Medical Devices” final rule as described previously in this document. -Revised the burden description and table to reflect that the Expedited Access Pathway and Priority Review have been superseded by the Breakthrough Devices Program.

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Annual Cost to Federal Government: $31,895,990

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.     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

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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: 03/20/2020

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