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News about GMP/cGMP

Draft Guidance Devices (FDA)

By end of April 2010 FDA issued the draft guidance entitled  "FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act" concerning devices.

 

This draft guidance shows how to obtain information on a device and how to submit a request for information.

Outcome:

Interested persons may submit to the Division of Dockets Management written or electronic comments regarding this document.

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

Electronic Comments: http://www.regulations.gov.

Link:

FDA/ Draft Guidance

Federal Register/ Draft Guidance

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