2019 was an interesting year for medical device companies. The EU MDR is set to come into effect in May 2021, and the industry is also facing impactful changes across the pond.

At the end of 2018, the FDA announced several upcoming changes to the way medical devices are approved in the United States. With no signs that these changes will be delayed, it’s just a matter of time before the FDA provides updated guidelines and requirements.

In this White Paper, we discuss three expected changes to the FDA medical device approval process

In particular, we will discuss:

  1. The proposed revision to the 510(k) process.
  2. The proposed new rules on the de novo pathway.
  3. The changes in the way e-health technologies will be evaluated.
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