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Medical Devices › Third-Party › Manufacturers

Knobbe Martens

FDA Accuses Third Party Testing Labs of Falsifying Data

Knobbe Martens on

The Food and Drug Administration (FDA) recently issued General Correspondence Letters to two third-party nonclinical testing laboratories. The FDA cited the laboratories “after discovering data that was falsified or otherwise...more

Alston & Bird

Addressing Data Integrity Challenges in Medical Device Submissions

Alston & Bird on

The Food and Drug Administration’s (FDA) recent rejection of all study data from Mid-Link Testing highlights the importance of using reliable, valid data for medical device premarket submissions. Our FDA/Food, Drug & Device...more

Jenner & Block

Client Alert: FTC Challenges Medical Device Coating Transaction

Jenner & Block on

On March 7, 2025, the FTC filed a complaint in federal court seeking to block GTCR BC Holdings, LLC, a Chicago private equity firm, from acquiring Surmodics, Inc. The FTC alleges that Surmodics is the leading provider of a...more

McDermott Will & Schulte

The Tale of Two CE Programs: OIG Compares Healthcare Provider and Third-Party Continuing Education in Recent Advisory Opinion

McDermott Will & Schulte on

The Office of Inspector General of the US Department of Health and Human Services (OIG) issued Advisory Opinion 22-14 (AO 22-14) on June 29, 2022, concerning continuing education (CE) programs to be offered by an...more

Thomas Fox - Compliance Evangelist

Four Things Compliance Practitioner Should Know About the Eurasian Economic Union

Thomas Fox - Compliance Evangelist on

Four Things Compliance Practitioner Should Know About the Eurasian Economic Union - An effective Compliance risk management at emerging markets for any business significantly depends on timeous observation of changes in...more

Arnall Golden Gregory LLP

FDA Issues Draft Guidance on 510(k) Third Party Review Program

Arnall Golden Gregory LLP on

The Center for Devices and Radiological Health (CDRH) recently issued a draft guidance on the 510(k) Third Party (TP) Review Program.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

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