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FDA issues guidance on pre-market approval applications

Device Regulation Alert: Safety, Compliance and Reimbursement News, July 28, 2008

Four different types of action by the FDA can affect the agency’s review time for pre-market approval applications (PMA).

All four actions stop the review clock, or the period of time allowed for FDA review. In recently updated guidance, FDA and Industry Actions on Premarket Approval Applications (PMAs): Effect on FDA Review Clock and Goals, the FDA explained what the actions are and what is needed to resolve problems and restart the review. The actions include:

• Approvable orders, which require the applicant to resolve deficiencies in a PMA.
• Major deficiency letters, which require the applicant to supply significant information that is missing from the application.
• Not approvable letters, for items the FDA believes cannot be approved, which keep the application on hold while the applicant is given the opportunity to respond. The agency generally issues these only after sending a major deficiency letter and giving the applicant a chance to respond. 
• Denial letters, which the agency issues when the review is complete.

The guidance also discusses the review cycle and performance goals the FDA has for processing both expedited and non-expedited PMAs and supplements. Finally, the guidance addresses the various actions applicants can take after submitting an application, including:

• Making unsolicited major amendments that introduce substantial new data
• Making solicited major amendments in response to an FDA request in a deficiency letter or not approvable letter
• Clarifying already submitted data with minor amendments  
• Withdrawing the application

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