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FDA releases guidance on Interactive Review of Device Applications

Device Regulation Alert: Safety, Compliance and Reimbursement News, January 21, 2008

The FDA has issued new guidance regarding an interactive approach to premarket submissions for medical devices.

The guidance applies to review of:

• Premarket notification submissions (510ks)
• Premarket approval applications (PMA)
• PMA supplements
• Biologic license applications (BLA)
• BLA supplements

The goal of the interactive process, according to the guidance, is to speed up reviews by improving communication between the FDA and the device industry. Reviews will include more informal communication designed to avoid delays, reduce the number of review questions and review cycles, and speed industry response to FDA inquiries.

According to the guidance, the FDA and industry can communicate through:

• Regular mail
• E-mail
• Faxes
• Telephone calls
• Meetings via video or teleconferences or in person

Of these methods, the FDA said it prefers E-mail and faxes for efficiency and record keeping.

The interactive approach also favors less rigid timelines for communication, allowing for as-needed communication throughout a review. The Day 100 Meeting for PMAs will be maintained, however, according to the guidance. The guidance states the FDA may set applicant-specific deadlines on a case-by-case basis rather than adhering to rigid pre-set deadlines for communication. The guidance advises applicants to support the interactive process by submitting complete applications with full contact information and promptly responding to deficiencies the FDA highlights during review.

The guidance gives specific advice on when applicants should contact FDA lead reviewers, what the FDA's role should be in 510k reviews, BLAs and PMAs, and how the FDA should handle an applicant's failure to timely respond to deficiencies noted by the FDA.

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