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de novo medical device

MDUFA IV: US FDA Sets Performance Goals for De Novo Medical Device Reviews

EMERGO SUMMARY OF KEY POINTS:

  • US FDA has published performance goals for handling de novo medical device submissions.
  • De novo user fees and performance goals were established under the Medical Device User Fee Amendments of 2017 (MDUFA IV).
  • FDA has set a 150-day timeframe for review of de novo applications.

New US FDA FAQ Clarifies De Novo Medical Device User Fee Requirements

EMERGO SUMMARY OF KEY POINTS:

  • The US FDA has a new guidance out that includes a FAQ on MDUFA IV user fees and refund policies for de novo medical device premarket submissions.
  • Only de novo devices intended for pediatric applications and those submitted by government entities and not intended for commercialization will be exempt from user fees.
  • Because new user fees are substantial, de novo device applicants should carefully consider FDA policies described in the guidance.