The U.S. Food and Drug Administration (FDA) has launched the Center for Devices and Radiological Health (CDRH) Transparency Web site.
The site provides information about medical device and radiation-emitting product regulatory processes and decisions and summaries of data that provide the rationale for agency actions, according to the FDA. It includes information related to premarket submissions for approved and cleared products, postmarket performance and safety, compliance and enforcement, science and research, educational resources, and CDRH performance data.
The site also features a searchable total product life cycle database, which integrates premarket and postmarket medical device information from multiple data sources into a single snapshot. In the coming months, the FDA said it will expand the CDRH Transparency Web site to include premarket approval and clearance reviews.
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