Beck 2024 510 K

Beck 2024 510 K. The document, entitled “submission and review of sterility information in premarket notification (510 (k)) submissions for devices labeled as sterile,” provides. A comprehensive guide to samd 510 (k) submissions, featuring an unredacted 510 (k) as a practical example to illustrate fda submission requirements.

A 510 (k) is a premarket submission made to fda to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a. Redirecting the regulatory strategy from the special 510 (k) to the traditional 510 (k).