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New FDA Guidance for Medical Device 510(k) Submissions

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On Sept. 13 the FDA released FOUR new final guidance documents relating to 510(k) submissions - guidelines for traditional, abbreviated, special 510(k). They appear to be really harmonizing and solidifying the overall expectations for these submissions. As the names imply, these are not draft guidance documents, so expect that they will be enforced soon. Check out the official documents at the link below:
https://lnkd.in/esSgt-S
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Victoria Trafka

Victoria Trafka

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Thursday, 25 April 2024

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Consulting in: Medical Device, Orthopedic & Spinal Devices, Product Development, Design, 3D CAD,

Engineering, Finite Element Analysis, FEA, Quality Management System, QMS, ISO 13485,

ISO 9001, FDA Compliance, FDA 21 CFR 820, Design History Files & Remediation