Pre-amendments and post-amendment devices

Pre-amendments Devices

Pre-amendment devices are medical devices that were in commercial distribution before the enactment of the Medical Device Amendments Act of 1976. These devices are subject to less stringent regulations compared to devices introduced after the amendment. This is also called a “Grandfather” device which does not require 510k submission if the following criteria are achieved

  • Significantly no modifications or changes happened since May 28, 1976.
  • For which a regulation requiring PMA application has not been published by the FDA.
  • You must be the owner of the device on the market before May 28, 1976. (i.e Grandfathered)

Post-amendment Devices

Post-amendment devices, on the other hand, are those introduced after the enactment of the Medical Device Amendments Act of 1976 and are subject to the stricter regulatory requirements set forth by the U.S. Food and Drug Administration (FDA).

Post-amendment devices are medical devices that are placed on the market after the enactment of the Medical Device Amendment Act of 1976 and require any regulatory pathway for submission (i.e. 510(k) submission, PMA, Denovo etc..)

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De Novo Submission
De Novo Submission allows FDA to establish new product classifications for low to moderate-risk medical devices that meet existing device classifications, thereby significantly easing the regulatory authorization pathway.
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Non-Active Device 510k Submission Process
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