New FDA Guidelines for Informal Medical Device Application Review - Did You Know?


FDA has new guidelines for informal review processes for medical device applications. A new guidance is aimed at accelerating review times and suggests when and how applicants should contact the agency during a review cycle.


Since more resolute performance goals have been set forth by the agency after the 2007 FDA Amendment Act, increased interaction during the review process between the FDA and life science industries has become an issue of note. According to the guidance, interactive reviews will facilitate increased informal interaction between the FDA and applicants and enable the exchange of vital scientific and regulatory information. To view the guidance, follow the link below.

Read more about recent technological advances that are helping medical device companies maintain compliance and accelerate time to market.

FDA Links:

  • Interactive Review for Medical Device Submissions: 510(k)s, Original PMAs, PMA Supplements, Original BLAs, and BLA Supplements Full Article

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