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FDA issues guidance on PMA manufacturing information and operations

Device Regulation Alert: Safety, Compliance and Reimbursement News, February 4, 2008

Recent FDA guidance addresses how the agency reviews manufacturing information provided during premarket approval (PMA) and conducts inspections of manufacturing facilities.

The guidance applies to PMAs and some PMA supplements, discussing the timing and order of various steps in the review process. Specifically, it explains how the Office of Compliance and the Office of In Vitro Diagnostic Device Evaluation and Safety perform reviews and inspections of manufacturing processes.

It does not apply to premarket notification submissions (510ks), which generally do not involve premarket inspections.

First, the guidance explains the various types of PMAs and PMA supplements, including:

• Traditional PMAs (all elements in a PMA submitted at one time)
• Modular PMAs (sections of PMA information separately submitted)
• Expedited PMAs that warrant priority treatment
• Panel-track supplements
• 180-day supplements

The guidance lists the steps taken to review manufacturing information in the PMA and the timeframe for review. The initial review results in either a finding that manufacturing information is "acceptable" or in a deficiency letter asking the PMA applicant to submit more information. Initial reviews also determine if an inspection is required. The guidance recommends applicants be prepared for an inspection when the application is submitted.

Inspections can lead to a finding that no further action is needed, voluntary action is needed to correct deficiencies, or official action is needed because deficiencies exist that affect just the device addressed in the application or other marketed products as well.

Finally the guidance addresses the timing of various steps in the review and inspection process and provides flow charts to help explain the process. The guidance notes that delays can be caused by failure to respond to information requests, real-time questions during reviews, or the manufacturing process not being underway soon after the PMA is submitted.

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