The US Food and Drug Administration (FDA) has released a new draft guidance outlining what information should be included in premarket submissions for orthopedic non-spinal bone plates, screws, and washers.
The draft guidance is intended to clarify information in 510(k) submissions for class II orthopedic non-spinal, non-resorbable medical devices, including bone plates, screw systems, standalone bone screws, and washers for bone fixation. The agency’s goal with the draft guidance is “to facilitate consistency in information provided in submissions by addressing common deficiencies related to device description and performance testing and by identifying applicable cross-cutting guidances and consensus standards.”…
