The U.S. Food and Drug Administration (FDA) proposed a draft guidance document that provides recommendations to applicants, and submitters of 510(k) submissions for non-resorbable bone plates, screws, and washer devices on the information to include.
The scope covers devices that are indicated for orthopaedic bone fixation but do not include devices indicated for spinal, mandibular, maxillofacial, cranial, and orbital fracture fixation.
Electronic or written comments on the draft guidance should be submitted by 30 May 2023, to ensure that the Agency considers the comments before it begins to work on the final version.
Need to know more about Medical Devices regulation changes? Get in touch with RegASK’s experts.