Developing a 510(k) to achieve FDA Clearance
for Reprocessing of Single-Use Devices
Hi - thanks for your interest in the Developing a 510(k) to achieve FDA Clearance for Reprocessing of Single-Use Devices white paper!
To reprocess and sell a single-use medical device, a reprocessor must submit a 510(k) application to FDA and receive a clearance for that device. The submission process is highly formalized. However, leading up to the submission are months of technical development in reverse engineering and testing. This white paper describes not only the 510(k) process, but also the engineering process involved in compiling and submitting a 510(k).
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