News & Analysis as of

Manufacturers Food and Drug Administration Safety and Innovation Act

King & Spalding

FDA Warns Drug & Device Firms Against Delaying & Limiting Facility Inspections in New Draft Guidance

King & Spalding on

On December 16, 2022, the U.S. Food & Drug Administration (“FDA” or “Agency”) published an important and noteworthy draft guidance document entitled “Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a...more

Butler Snow LLP

Pro Te: Solutio Vol. 11 No. 1 – A Reflection on the First Ten Years

Butler Snow LLP on

It’s hard to believe a decade has passed since we delivered our first edition of Pro Te: Solutio to your door. Those years have brought enormous changes in the world and in our industry. Innovation has driven everything we...more

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FDA Issues Draft Guidance on 510(k) Third Party Review Program

The Center for Devices and Radiological Health (CDRH) recently issued a draft guidance on the 510(k) Third Party (TP) Review Program.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10 Key Takeaways from FDA’s Draft Guidance on 510(k) Modifications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The Draft Guidance may not significantly increase the number of 510(k)s filed, but likely would increase manufacturers’ procedural and documentation burdens.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

Morgan Lewis

Medical Device Update: FDA Issues Draft Guidance on Streamlined De Novo Classification Process

Morgan Lewis on

On August 14, the Food and Drug Administration (FDA) issued a draft guidance titled “De Novo Classification Process (Evaluation of Automatic Class III Designation).” The draft provides guidance on a streamlined process for...more

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