FDA releases draft guidance for plate, screw and washer devices for bone fixation

Key takeaways:

The draft guidance is for class II non-resorbable, non-spinal bone plate and screw systems, stand-alone bone screws and associated washers.
Comments on the draft guidance should be submitted by May 30.

The FDA released draft guidance that provides recommendations for premarket notification submissions for non-resorbable plate, screw and washer devices for orthopedic bone fixation.

The draft guidance is limited to class II, orthopedic, non-resorbable, non-spinal bone plate and screw systems, stand-alone bone screws and associated washers for which the safety and effectiveness are well established, according to the FDA. The FDA noted that the guidance is intended 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.

FDA HQ in Washington — FDA released draft guidance of recommendations for premarket notification submissions for non-resorbable orthopedic bone fixation devices. *Image: Adobe Stock*

Comments on the draft guidance should be submitted by May 30.

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FDA releases draft guidance for plate, screw and washer devices for bone fixation

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