Guidance on 510k submissions for full field digital Mammography systems
Device Regulation Alert: Safety, Compliance and Reimbursement News, June 9, 2008
New FDA guidance offers assistance in preparing pre-market notification submissions (510(k)) for display accessories of full-field digital mammography (FFDM) systems used in detecting breast cancer. The guidance applies to medical image hardcopy devices and picture archiving and communications systems—both class II devices. It does not apply to ophthalmic hardcopy image devices or ophthalmic image management systems.
The device description should include all data processing—from input of data to display, printing, and archiving of data. The guidance recommends specific details to include in the description of soft copy display systems, hardcopy display systems, picture archiving and communications systems, review work station, and image review manipulation software. Specific technical information relating to the testing performed on those items is also recommended.
Risks of inaccurate data display should be addressed in the submission and a description provided of efforts to identify any other risks. Finally, the guidance sets forth specific details to include in the 510(k) with regard to labeling information.
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