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 New Guidance by FDA: Interactive Review for Medical Device Submissions: 510(k)s, Original PMAs, PMA Supplements, Original BLAs, and BLA Supplements

This guidance document for outlining the interactive review process is designed to help accomplish the following:

• improve the interaction between the FDA review staff and the applicants during the review process;
• prevent unnecessary delays in the completion of the review, thus reducing the overall time to market;
• try to ensure that FDA’s concerns are clearly communicated to the applicant during the review process, as appropriate;
• minimize the number of review cycles;
• minimize the number of review questions conveyed through formal requests to applicants for additional information; and
• ensure timely responses from applicants.

The guidance document outlines the ways you can communicate with the FDA and how that communications should take place.

It is good to see the FDA trying to take a proactive approach to letting the industry know how they can communicate with the agency during their reviews since the industry is now paying for this review.

This guidance document does not include appeals, including requests for dispute resolution, and general policy discussions.

And remember: FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidance documents describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.

For more information on this guidance document you can go to the following link:
http://www.fda.gov/cdrh/ode/guidance/1655.html
or contact mdi at info@mdiconsultants.com and put interactive guidance in the subject.

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