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Food and Drug Administration (FDA) › Medical Devices › Exemptions

Holland & Knight LLP

FDA's Final Rule on Laboratory Developed Tests Comes with Controversy and Concerns

Holland & Knight LLP on

The U.S. Food and Drug Administration's (FDA) recent announcement of a final rule extending regulatory oversight to laboratory developed tests (LDTs) has sparked controversy. As discussed in a previous Holland & Knight alert,...more

Ogletree, Deakins, Nash, Smoak & Stewart,...

Illinois Federal Judge Finds Another Eyewear Virtual Try-on Class Action Is Exempt Under BIPA’s Healthcare Exemption

Ogletree, Deakins, Nash, Smoak & Stewart,... on

A federal judge in Illinois recently ruled that online shoppers cannot sustain claims that a virtual try-on (VTO) tool that allegedly scans facial geometry to preview the look of sunglasses on their face violates the...more

King & Spalding

FDA Reverses HHS Exemption of Class I and Class II Medical Devices from Section 510(k)

King & Spalding on

Premarket Notification Again Required for Patient and Surgeon's Examination Gloves and Dozens of Class II Devices Proposed for Exemption by Former HHS Secretary - On April 16, 2021, the Food and Drug Administration (“FDA”...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

Hogan Lovells

MDR single report exemption and ASRs: Coming to an end for most reporters

Hogan Lovells on

The Medical Device Reporting (MDR) regulation provides a mechanism for the U.S. Food and Drug Administration (FDA or the Agency), as well as medical device manufacturers, to identify and monitor adverse events (deaths,...more

Knobbe Martens

Certain Medical Devices Exempted from 510(k) Requirements

Knobbe Martens on

The Food and Drug Administration (FDA) recently identified a list of Class II Medical Devices that, when finalized, will be exempt from premarket notification (510(k)) requirements. This publication was made by the FDA...more

Stinson - Benefits Notes Blog

New Law Permits Stand-Alone Health Reimbursement Arrangements (HRAs) For Small Employers

Stinson - Benefits Notes Blog on

On December 13, 2016 President Obama signed into law the 21st Century Cures Act. The law had been approved with bipartisan support in the House by a vote of 392 to 26 and in the Senate by a vote of 94 to 5. The law addresses...more

Snell & Wilmer

FDA Issues Final Guidance on Intent to Exempt Certain Medical Devices from Premarket Notification Requirements

Snell & Wilmer on

On July 1, 2015 the FDA issued its final guidance regarding the intent to exempt certain unclassified medical devices, certain Class II medical devices, and certain Class I medical devices that are subject to the reserved...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

Foley Hoag LLP

Foley Hoag and AdvaMed Collaborate on Industry Guidance on Retail Exemption in Final Device Tax Regulations

Foley Hoag LLP on

Foley Hoag and the Advanced Medical Technology Association (AdvaMed) collaborated on an important resource guiding manufacturers, importers, and producers of taxable medical devices through the newly released Internal Revenue...more

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