News & Analysis as of

510(k) RTA Food and Drug Administration Safety and Innovation Act

Arnall Golden Gregory LLP

FDA Issues Draft Guidance on 510(k) Third Party Review Program

The Center for Devices and Radiological Health (CDRH) recently issued a draft guidance on the 510(k) Third Party (TP) Review Program. The TP Review Program (formerly known as the Accredited Persons Program) allows FDA to...more

Morgan Lewis

10 Key Takeaways from FDA’s Draft Guidance on 510(k) Modifications

Morgan Lewis on

The Draft Guidance may not significantly increase the number of 510(k)s filed, but likely would increase manufacturers’ procedural and documentation burdens. The US Food and Drug Administration (FDA or the Agency) issued...more

Mintz - Health Care Viewpoints

FDA Releases Revised Guidance on Device Modification Policy

FDA released two new draft guidances on Monday, August 8 in an attempt to help device manufacturers determine when a modification triggers the obligation to file a new 510(k) under 21 C.F.R. § 807.81(a)(3). The first draft...more

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