MedTech Dive September 27, 2022
Nick Paul Taylor

Dive Brief:

  • The Food and Drug Administration has concluded it’s impractical to implement the agency’s proposed software precertification program under its current statutory and regulatory authorities.
  • A pilot assessment of the program ran into challenges, including the realization that the De Novo submission-based approach outlined in the FDA’s 2019 plan was not the optimal test method.
  • The regulator concluded that the “rapidly evolving technologies in the modern medical device landscape” would benefit from “a new regulatory paradigm.” A legislative change will be needed to implement that paradigm, the FDA said in a report released Monday.

Dive Insight:

The FDA proposed the precertification program to adapt regulatory processes originally intended for hardware to the faster development and update...

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Topics: FDA, Govt Agencies, Medical Devices
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