Certification Requirements, Food and Drug Administration (FDA), Medical Devices

US Emerging as Top Global Medtech Destination

Goodwin on 3/11/2025

For years, medtech firms around the globe (and certainly European companies) introduced their products in Europe, which requires obtaining a CE mark certifying compliance with relevant EU health and safety standards, prior to...more

Appealing a denial of a drug/medical device export certificate: FDA final guidance

Hogan Lovells on 11/19/2019

Drug and medical device manufacturers seeking to export a product from the United States may need to obtain from the U.S. Food and Drug Administration (FDA) a Certificate to Foreign Government (CFG) in order to satisfy the...more

FDA Testing New Approaches for Review of Digital Health Device Applications

Dorsey & Whitney LLP on 1/14/2019

On January 7, 2019, FDA Commissioner Scott Gottlieb announced significant updates to the FDA’s pilot Software Pre-Certification Program, sometimes referred to more broadly as a Digital Health Pre-Certification Program...more

Navigating the U.S. FDA regulatory clearance for digital medical devices: the 510(k) and Pre-Cert program

Hogan Lovells on 9/11/2018

Consumer demand for digital health care devices has soared, and it shows no signs of slowing down. But when bringing these devices to market, companies in the digital health space are confronted with numerous challenges. ...more

To certify or not to certify? FDA has answered the question

Hogan Lovells on 6/14/2017

On June 7, 2017, FDA issued a revised guidance document, Form FDA 3674 – Certifications To Accompany Drug, Biological Product, and Device Applications/Submissions, to clarify when sponsors should submit Form FDA 3674...more

Certification Requirements › Food and Drug Administration (FDA) › Medical Devices

US Emerging as Top Global Medtech Destination

Appealing a denial of a drug/medical device export certificate: FDA final guidance

FDA Testing New Approaches for Review of Digital Health Device Applications

Navigating the U.S. FDA regulatory clearance for digital medical devices: the 510(k) and Pre-Cert program

To certify or not to certify? FDA has answered the question

"My best business intelligence, in one easy email…"