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DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center WO66-G609 Silver Spring, MD 20993-0002 ROCHE DIAGNOSTICS
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What is performa 510k summary statement_revised?
Performa 510k summary statement_revised is a document that summarizes key information about a medical device subject to FDA premarket notification requirements.
Who is required to file performa 510k summary statement_revised?
Manufacturers or sponsors of medical devices seeking FDA clearance through the 510k process are required to file performa 510k summary statement_revised.
How to fill out performa 510k summary statement_revised?
The performa 510k summary statement_revised can be filled out by providing information such as device description, indication for use, labeling, summary of safety and effectiveness data, and more.
What is the purpose of performa 510k summary statement_revised?
The purpose of performa 510k summary statement_revised is to provide FDA reviewers with a concise summary of the information contained in the full 510k submission.
What information must be reported on performa 510k summary statement_revised?
Information such as device description, intended use, substantial equivalence to predicate device, summary of testing data, and labeling information must be reported on performa 510k summary statement_revised.
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