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FDA launches pre-certification program for developers of healthcare-related software

  • The FDA names nine companies that will participate in its pilot program to precertify healthcare software developers with the aim of potentially reducing the amount of information the agency requires for review. The agency says the initiative will be a tailored approach toward digital health technology by virtue of looking at the software developer instead of primarily the product.
  • After reviewing software developers’ systems for design, validation and maintenance, the FDA will determine if the company meets quality standards and, if so, they will be precertified.
  • The agency expects the program to inform on key metrics and performance indicators that may lead to a lower information burden for applicants. It was launched on July 27 as part of its Digital Health Innovation Action Plan.

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