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US FDA Guidance Explains User Fees for Medical Device Reviews

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The US Food and Drug Administration has published guidance on which types of medical device premarket approvals (PMA) and 510(k) premarket notifications incur user fees for premarket review following passage of the Medical Device User Fee Amendments of 2012 (MDUFA III).

The regulator has identified the following PMA applications as subject to user fees:

  • Original and modular PMAs
  • 180-Day Supplements
  • Premarket reports
  • Real-Time Supplements
  • Licensing Agreement PMAs
  • 30-Day Notices
  • Panel-Track Supplements
  • Periodic Reports

PMA medical device applications exempt from FDA user fees include submissions intended solely for pediatric patients, first-time PMAs submitted by companies with less than $30 million in gross revenues, and PMAs submitted by state or federal government entities that do intend to commercially distribute devices under review.

Regarding 510(k) medical device clearance applications, the FDA guidance lists traditional, abbreviated and special premarket notification submissions as generally subject to user fees. The following instances, however, would exempt applicants from having to pay user fees:

  • 510(k) submission reviewed by an FDA-accredited Third Party that also provides Substantial Equivalence recommendation
  • 510(k) submissions pertaining to devices targeting only pediatric populations
  • 510(k) submissions from state or federal government entities

The FDA is currently accepting public comment on the new PMA and 510(k) user fee guidances.

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