FDA launches transparency website for radiation-emitting devices

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The FDA launched the Center for Devices and Radiological Health (CDRH) Transparency website Monday, as part of the agency’s transparency initiative to provide information about medical device and radiation-emitting product regulatory processes and decisions, and summaries of data that provide the rationale for agency actions.

CDRH’s previous site provided information about approved products, industry guidance, medical device safety and adverse event reports. On the new website, this and additional information are displayed in a user-friendly format, according to the FDA.

The agency said the site includes information related to the following topics:

  • Premarket submissions for approved and cleared products: Summaries of FDA’s review of the documents and data that companies submit to FDA when requesting clearance or approval to market a new or improved device, and the systems FDA uses to evaluate these submissions.
  • Postmarket performance and safety: Documents and data describing how well devices perform after they are on the market, and information about how FDA monitors medical device safety.
  • Compliance and enforcement: Official actions that FDA has taken in response to problems with devices or device companies.
  • Science and research: Research programs at CDRH or sponsored by CDRH.
  • Educational resources: Information to help industry and others understand CDRH requirements and processes.
  • CDRH performance data: Metrics about CDRH programs.

The website also features a searchable Total Product Life Cycle database, which integrates premarket and post-market medical device information from multiple data sources into a single snapshot, according to the FDA. The website also includes a feedback feature that will allow FDA to collect input and suggestions from the public about the information provided.

“The Center for Devices and Radiological Health Transparency website gives the public a window into our work,” said CDRH’s Director Jeffrey Shuren, MD.

In the coming months, the FDA will expand the CDRH Transparency website to include premarket approval and clearance reviews.