PREMARKET APPROVAL OF MEDICAL DEVICES

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
109907	PREMARKET APPROVAL OF MEDICAL DEVICES	Migrated

ICR Details

OMB Control No: 0910-0231	ICR Reference No: 198607-0910-001
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: PREMARKET APPROVAL OF MEDICAL DEVICES
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 10/20/1986
	Date Received in OIRA: 07/23/1986
Terms of Clearance: The information collection requirements set forth in 21 cfr 814 are approved under omb #0910-0231. - Under section 814.20(b)(3)(iv), applicants would only be required to report information that is actually known to the applicant. -under section 814.20(b)(3) the summary would only be required to contain brief statements of major points and would typically be no longer than 10-15 pages in length. -under section 814.20(b)(5), manufacturers would only be required to report on voluntary standards that were specifically applicable to their device, and that were developed in accord with fda's policy statement on standard development (50 f.r. 43081). upon request, fda will provide to applicants a complete list of standards meeting these criteria that are applicable to their device. -under section 814.20(b)(10), current practice would not change for labeling, and advertising (that is not labeling) would not be required to be reviewed prior to approval of the device. -under section 814.20(e) periodic reports would be limited to studies sponsored by the applicant or to which the applicant has reasonable access. -under section 814.82(a)(4), if patient i.d. cards are required in situations when devices are sold directly to health practitioners, a (continued)

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/1989	09/30/1989
Responses	400	0	0
Time Burden (Hours)	492,840	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: THIS RU DESCRIBES THE CONTENTS OF A PREMARKET APPROVAL APPLICATION (PMA) FOR A MEDICAL DEVICE. THE FDA REQUIRES THIS INFORMATION FROM MEDICAL DEVICE MANUFACTURERS IN ORDER TO GET APPROVAL FOR MARKETING DEVICES SHOWN TO BE SAFE AND EFFECTIVE, OR DISAPPROVE DEVICES NOT SHOWN TO BE SO.

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Authorizing Statute(s): None

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:

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Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
PREMARKET APPROVAL OF MEDICAL DEVICES

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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	400	0	0	400	0	0
Annual Time Burden (Hours)	492,840	0	0	492,840	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:

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

Burden Reduction Due to:

Short Statement:

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Annual Cost to Federal Government: $0

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]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? Uncollected

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: 07/23/1986

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