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Medical Devices › Notification Requirements

Arnall Golden Gregory LLP

Tell Me, I’ve Got to Know: FDA Issues Draft Guidance on 506J Notifications for Medical Devices

Arnall Golden Gregory LLP on

Bob Dylan sang, “Tell Me, I’ve Got to Know.” In January 2022, the Food and Drug Administration said the same to the medical device industry when it issued a draft guidance, “Notifying the FDA of a Permanent Discontinuance or...more

Hogan Lovells

HHS proposal to exempt medical devices from 510(k) process halted

Hogan Lovells on

On January 15, the U.S. Department of Health and Human Services (HHS) published a notice and request for information (RFI) proposing to exempt 91 medical devices – for which the normal regulatory process was temporarily...more

King & Spalding

France – Thresholds for Prior Authorization of Agreements with Healthcare Professionals and for Benefits of Low Value are Finally...

King & Spalding on

The two arrêtés [orders] setting thresholds for transfers of value from pharmaceutical and medical devices companies to healthcare professionals, institutions, and other actors of the healthcare sectors (Healthcare...more

Faegre Drinker Biddle & Reath LLP

Christmas in July for Wellness Apps and Devices

Faegre Drinker Biddle & Reath LLP on

The Food and Drug Administration (FDA) released a final guidance on July 29, 2016, saying that it does not plan to require pre-market review for low-risk "general wellness products," such as wearable fitness monitors,...more

Knobbe Martens

FDA Plan to Exempt Medical Devices

Knobbe Martens on

The US Food and Drug Administration (“FDA”) recently released updated recommendations to exempt certain unclassified, Class I, and Class II medical devices from premarket notification requirements. The devices include...more

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