Regulatory Focus™ > News Articles > FDA Releases PMA Summaries for Q4 2011

FDA Releases PMA Summaries for Q4 2011

Posted 15 March 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) is updating its list of available safety and effectiveness summaries of Premarket Approvals (PMAs) to include all decisions made in the fourth quarter of 2011.

The updated list includes the PMA docket number, applicant, trade name of the product and the product's approval date, as well as the complete safety and effectiveness summary by FDA.

All 15 products added to the list during the 4th quarter of 2011 were approved.

Under section 515(g) of the Federal Food, Drug and Cosmetic Act, manufacturers have a 30-day period in which to request reconsideration of an FDA decision once the list is published.

The in-depth list is scheduled to be posted in full on 16 March on the Center for Devices and Radiological Health's website.


Read more:

Federal Register - Medical Devices: Availability of Safety and Effectiveness Summaries for Premarket Approval Applications

FDA - Device Approvals and Clearances


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