Premarket Approval of Medical Devices - 21 CFR Part 814

Forms and Documents

Document Name	Status
83C memo--0231-PMA--AEDs 08-27-14 (3).doc Justification for No Material/Nonsubstantive Change	2014-09-17
0231 ss 11-20-13.doc Supporting Statement A	2013-11-20

IC Document Collections

IC ID	Document Title	Status
5826	Premarket Approval of Medical Devices - 21 CFR Part 814	Modified
209459	Premarket Approval of Medical Devices: maintenance of records	Unchanged

ICR Details

OMB Control No: 0910-0231	ICR Reference No: 201409-0910-013
Status: Historical Active	Previous ICR Reference No: 201311-0910-010
Agency/Subagency: HHS/FDA	Agency Tracking No: CDRH
Title: Premarket Approval of Medical Devices - 21 CFR Part 814
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 12/15/2014
	Date Received in OIRA: 10/17/2014
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2017	01/31/2017	01/31/2017
Responses	2,684	0	2,650
Time Burden (Hours)	133,448	0	111,070
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
   US Code: 21 USC 515(d)(6) 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:
	78 FR 44128	07/23/2013
30-day Notice:	Federal Register Citation:	Citation Date:
	78 FR 64220	10/28/2013
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 - 21 CFR Part 814
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	2,684	2,650	0	34	0	0
Annual Time Burden (Hours)	133,448	111,070	0	22,378	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: Miscellaneous Actions

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

Burden Reduction Due to:

Short Statement: Automated external defibrillators systems (AEDs) (including the AED device and its accessories (i.e., pad electrodes, batteries, and adapters)) are currently in class III, however, currently respondents submit 510(k) premarket notifications for these preamendments devices (see proposed order for additional background). The Agency issued a proposed order in the Federal Register of March 25, 2013, "Effective Date of Requirement for Premarket Approval for Automated External Defibrillator System" (78 FR 17890), which calls for premarket approval applications (PMAs) for AED devices. As a result, respondents will be required to submit PMAs instead of 510(k)s for AEDs. We estimate that we will receive approximately 12 new PMAs for AED devices and 21.5 for AED accessories as a result of the order, causing an increase of approximately 22,378 hours in the PMA ICR (0910-0231).

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Annual Cost to Federal Government: $24,736,576

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

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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: 10/17/2014

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