FDA update August 17th, 2011

Draft Guidance Post market Surveillance Under Section 522 of the Federal Food, Drug and Cosmetic Act

FDA has announced the availability of the draft guidance entitled "Procedures for Handling Section 522 Postmarket Surveillance Studies." This guidance document is intended to assist device manufacturers subject to a section 522   post market surveillance order imposed by FDA by providing an overview   of section 522 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), procedural information on how to fulfill section 522 obligations,   and recommendations on the format, content, and review of postmarket surveillance study submissions. This draft guidance is not final nor is   it in effect at this time.

When final, this document will supersede "Guidance for Industry and FDA Staff; Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act"issued on April 27, 2006

Postmarket surveillance under section 522 of the Federal Food, Drug, and Cosmetic Act (the act) is one means by which the Food and Drug Administration (FDA) can obtain additional safety and/or effectiveness data for a device after it has been cleared through the premarket notification (510(k)) process or approved through the premarket approval application (PMA), humanitarian device exemption (HDE), or product development plan (PDP) process, when it is necessary to protect the public health. Postmarket surveillance is not a substitute for obtaining the necessary premarket information to support 510(k) clearance or PMA, HDE, or PDP approval. FDA) amended section 522 of the act by adding class II and class III devices expected to have significant use in pediatric populations as a category of devices potentially subject to a postmarket surveillance order, authorizing the agency to order postmarket surveillance for durations longer than 36 months and as a condition of clearance or approval for devices within this category, and adding a dispute resolution provision.

This guidance document is intended to assist those subject to section 522 postmarket surveillance imposed by FDA by providing:

  • an overview of section 522 of the act,
  • procedural information on how to fulfill 522 obligations
  • Recommendations on the format, content, and review of postmarket surveillance study submissions.

Substantive additions to the 2006 version of this guidance document include: (1) guidance regarding the pediatric criterion added by section 307 of FDA; (2) recommendations for the content of postmarket surveillance study submissions, consistent with previous FDA requests; (3) descriptions of study status categories that more precisely indicate study progress and the adequacy of the data; and (4) updated procedures based on the transfer of the program area to Division of Epidemiology (DEPI), Office of Surveillance and Biometrics (OSB).

PLEASE BE AWARE THAT THIS IS YOUR CHANCE TO MAKE YOUR THOUGHTS TO BE KNOWN: Written comments and suggestions may be submitted at any time for FDA consideration to the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD, 20852. When submitting comments, refer to Docket No. FDA-2011-D-0514.

Or you can send your comments within 90 days at info@mdiconsultants.com and REF: Draft Guidance Post market Surveillance For more information on this guidance you can go to the following linkhttp://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM268141.pdf