Guidance Medical Device ISO 13485: 2003 Voluntary Audit Report Submission Pilot Program

Forms and Documents

Document	Type	Status	Availability
0700_SS_12-12-30-14.doc	Supporting Statement A	Uploaded 2015-01-08	Available
ISO 13485 guidance--11-07-14 w-updated PRA section.doc	Supplementary Document	Uploaded 2014-12-08	Available

IC Document Collections

IC ID	Collection	Type	Status	Form
198427	Recurring	Other-Screenshots	Modified
198426	First Year (one time)	Other-Screenshots	Modified

ICR Details

OMB Control No: 0910-0700	ICR Reference No: 201412-0910-004
Status: Historical Active	Previous ICR Reference No: 201107-0910-002
Agency/Subagency: HHS/FDA	Agency Tracking No: CDRH
Title: Guidance Medical Device ISO 13485: 2003 Voluntary Audit Report Submission Pilot Program
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 05/18/2015
	Date Received in OIRA: 01/12/2015
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2018	36 Months From Approved	05/31/2015
Responses	2,267	0	2,133
Time Burden (Hours)	28,914	0	27,186
Cost Burden (Dollars)	68,010	0	63,990

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Abstract: This ICR collects information from medical device manufacturers, whose establishment has been audited under one of the regulatory systems implemented by the Global Harmonization Task Force (GHTF) founding members using ISO 13485:2003 Technical Corrigendum 1:2009 (or a national adoption of this standard, e.g., EN ISO 13485:2003/AC:2009, CAN/CAS ISO 13485 13485:2003) "Medical devices – Quality management systems – Requirements for regulatory purposes." Manufacturers may voluntarily submit the resulting audit report to FDA. If, based on that report, FDA determines there is minimal probability -- in light of the relationship between the quality system deficiencies observed and the particular device and manufacturing processes involved -- that the establishment will produce nonconforming and/or defective finished devices, then FDA intends to use the audit results as part of its risk assessment to determine whether that establishment can be removed from FDA's routine inspection work plan for one year from the last day of the ISO 13485:2003 audit. The voluntarily submitted ISO 13485:2003 audit report provides FDA some information on the conformance of the manufacturer with basic and fundamental quality management system requirements for medical devices.

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Authorizing Statute(s): US Code: 21 USC 374 (g)(7) Name of Law: Federal Food, Drug, and Cosmetic Act
  

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:
	79 FR 36318	06/26/2014
30-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 78444	12/30/2014
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
First Year (one time)
Recurring

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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	2,267	2,133	0	134	0	0
Annual Time Burden (Hours)	28,914	27,186	0	1,728	0	0
Annual Cost Burden (Dollars)	68,010	63,990	0	4,020	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: The number of respondents for "First year, electronic set-up and verification certificate" has increased from 1,600 to 1,700. The number of respondents for "Audit report submission" has increased from 1,600 to 1,700.

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Annual Cost to Federal Government: $566,974

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: 01/12/2015

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