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GUIDANCE DOCUMENT

The Review and Inspection of Premarket Approval Application Manufacturing Information and Operations Guidance for Industry and FDA Staff January 2008

Final

The Review and Inspection of Premarket Approval Application Manufacturing Information and Operations

Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

The Medical Device User Fee and Modernization Act of 2002 (MDUFMA) amended the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 321 et seq.) to allow for the collection of user fees for the review of certain marketing applications. A portion of the fee collected for premarket approval applications (PMAs) will help cover the costs associated with the review of the PMA manufacturing section information and the inspection of the manufacturing facilities. In a letter to Congress that accompanied the user fee legislation, the Secretary of Health and Human Services committed to “improve the scheduling and timeliness of preapproval inspections.”

This guidance explains for applicants the process involved with the review of a PMA manufacturing section and inspection of the manufacturing operations described in the manufacturing section. This guidance is also generally applicable to the process involved with the review of manufacturing information in certain PMA supplements. This guidance does not address premarket notification (510(k)) submissions because a premarket inspection is not ordinarily conducted for this type of premarket submission. FDA believes that the procedural information outlined in this document should help applicants and FDA schedule and complete their work in a timely manner.


Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.