FDA 510 K Clearance & Premarket Approval

  • September 8, 2021 8:55 am
  • Mumbai, India, Asia
  • 486 views

Description

FDA 510k is a premarket approval process made by FDA to signify that the device to be marketed is at least as safe and effective, substantially equivalent, to a lawfully marketed device (21 CFR 807.92) that is not subject to premarket approval.
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