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US FDA issues Draft Guidance on Premarket Approval (PMA) Acceptability

bio_subbu

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Dear All

The US Food and Drug Administration (USFDA) has issued a draft guidance document on 31st July 2012 titled “Draft Guidance for Industry and Food and Drug Administration Staff: Acceptance and Filing Review for Premarket Approval Applications (PMAs)”. The document focuses on the regulatory and scientific criteria for making an ‘Accept’ or ‘Refuse to Accept’ decision and a ‘File’ or ‘Not File’ decision for medical device premarket applications (PMAs). The draft is intended to clarify the criteria for accepting and filing PMAs and applies to original PMAs and PMA panel-track supplements reviewed by the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER). For more details please refer here..
 

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