FDA Draft Guidance Addresses Procedures For Surveillance Studies After Approval

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The Food and Drug Administration Aug. 16 announced the availability of a draft guidance to aid medical device manufacturers when the agency orders Section 522 postmarket surveillance studies.

Comments on the guidance, entitled “Procedures for Handling Section 522 Postmarket Surveillance Studies,” are due Nov. 14, according to the Federal Register notice (76 Fed. Reg. 50740).

Postmarket surveillance under Section 522 of the Federal Food, Drug, and Cosmetic Act is one means by which FDA can obtain additional safety and/or effectiveness data for a device after it has been cleared through the 510(k) premarket 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.

Such surveillance is not a substitute for getting the necessary premarket information to support 510(k) clearance or PMA, HDE, or PDP approval.

Section 522 authorizes FDA to require postmarket surveillance in any of the following instances: a class II (moderate risk) or class III (highest risk) device for which failure of the device would be reasonably likely to have a serious adverse health consequence; a class II or class III device expected to have significant use in pediatric populations; or a class II or class III device intended to be a life-sustaining or life-supporting device used outside of a user facility.

According to FDA, the guidance document is intended to assist device manufacturers subject to a Section 522 postmarket surveillance order by providing an overview of the section, procedural information on how to fulfill Section 522 obligations, and recommendations on the format, content, and review of study submissions.

The guidance updates one that was issued on the same subject in 2006. According to FDA, substantive additions to the 2006 version of this guidance document include:

• guidance regarding the pediatric criterion added by Section 307 of the FDA Amendments Act of 2007;

• recommendations for the content of postmarket surveillance study submissions, consistent with previous FDA requests;

• descriptions of study status categories that more precisely indicate study progress and the adequacy of the data; and

• updated procedures based on the transfer of the program area to Division of Epidemiology (DEPI), Office of Surveillance and Biometrics (OSB). 

The draft guidance is at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm268064.htm .

The Federal Register notice is at http://www.gpo.gov/fdsys/pkg/FR-2011-08-16/pdf/2011-20727.pdf .