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FDA publishes fees for fiscal year 2020

  • Posted by: inetika
  • Category: GLOBAL NEWS

The US Food and Drug Administration has released details of the fees that will apply to medical device manufacturers seeking market clearance of new products for the US market for the Agency’s fiscal year 2020, which starts on 1 October 2019.

A general 6% increase has been introduced, but a reduced increase is noted for PMA, PDP and BLA submissions, where the increase is closer to 3%.

The new fees are indicated in the following table.

The FDA guidance for small businesses does not yet appear to be available, but will undoubtedly be available shortly.

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