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FDA Proposes Lower Risk Classification, Special Controls for External Pacemakers
Date:10/17/2011

not issue regulations requiring applications for premarket approval (PMAs).

In 2009, CDRH began the process for the review of the remaining Class III preamendment device types subject to 510(k) review to determine whether to reclassify them or require PMAs.  

External pacemaker pulse generators are one of the 22 remaining Class III preamendment devices that have been regulated through the 510(k) premarket submission program, rather than the premarket approval program required for other Class III devices.  

The proposed rule and draft special controls guidance do not significantly change the FDA's review of external pacemakers pulse generators, but they do provide manufacturers with clarity and specific guidance on what information is needed in a 510(k) for these products.

For more information:

Draft Class II Special Controls Guidance Document: External Pacemaker Pulse Generator

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm275701.htm

Proposed Rule: Reclassification of External Pacemaker Pulse Generator Devices

http://www.gpo.gov/fdsys/pkg/FR-2011-10-17/html/2011-26625.htm

515 Program Initiative

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHTransparency/ucm240310.htm

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give of
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SOURCE U.S. Food and Drug Administration
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