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Exemptions Food and Drug Administration (FDA)

Epstein Becker & Green

FDA Guidance on DSCSA Small Dispenser Exemption and Exemptions and Waivers for Other Trading Partners

Epstein Becker & Green on

In June 2024, the U.S. Food and Drug Administration ("FDA") clarified, with respect to the Drug Supply Chain Security Act (“DSCSA”), that it will not extend the one-year stabilization period for the enhanced drug distribution...more

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

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

Fox Rothschild LLP

Federal Court Rejects Exemption Request In One Of PA’s First Mask Mandate Cases

Fox Rothschild LLP on

In one of the first cases in Pennsylvania to address the great student masking debate, a federal court has rejected several arguments made by parents seeking to exempt their children from a universal mask requirement imposed...more

Parker Poe Adams & Bernstein LLP

CDC Adds COVID-19 Vaccination Mandate for Green Card Applicants

The U.S. government recently imposed additional restrictions on foreign nationals related to the COVID-19 pandemic. Beginning October 1, 2021, foreign nationals applying for permanent residency (green cards) must provide...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 Publishes Final SUNSET Rule With New Exemptions and Timelines

Hogan Lovells on

On 19 January 2021, the U.S. Department of Health and Human Services (the Department or HHS) published in the Federal Register Final Rule entitled “Securing Updated and Necessary Statutory Evaluations Timely (SUNSET).” The...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

Arnall Golden Gregory LLP

The COVID-19 Vaccine and Healthcare Employers: To Mandate or Not to Mandate?

With COVID-19 vaccines now being distributed to healthcare facilities, including hospitals, long-term care, and other healthcare providers, employers in these industries are faced with an immediate decision: whether to...more

Akin Gump Strauss Hauer & Feld LLP

Executive Order on Essential Medicines: A Timeline and Overview of Key Provisions

On August 6, President Trump issued an Executive Order (EO) titled “Ensuring Essential Medicines, Medical Countermeasures and Critical Inputs Are Made in the United States.” The far-reaching EO seeks to ensure the domestic...more

Perkins Coie

Coffee Regulations Offer Affirmative Defense in Proposition 65 Suit

Perkins Coie on

On July 15, 2020, a California state court made an important ruling upholding the validity and application of regulations exempting coffee from Proposition 65 warnings. Better known as Proposition 65, the California’s...more

McDermott Will & Emery

TTB and FDA Relax Restrictions on the Production of Hand Sanitizers by Alcohol Manufacturers

McDermott Will & Emery on

With the increasing pace of the spread of the Coronavirus (COVID-19) and the related emergent need to increase the available supply for hand sanitizer products across the United States, the Alcohol and Tobacco Tax and Trade...more

Verrill

More Proposed Changes to CCPA Geared to Health Care and Life Sciences Industries

Verrill on

The California Consumer Privacy Act of 2018 (“CCPA”) took effect on January 1, 2020. Days later on January 8, 2020, the California Senate Health Committee unanimously approved Senate bill A.B. 713 (the “Bill”) to establish...more

Robins Kaplan LLP

Financial Daily Dose 10.1.2019 | Top Story: Credit Suisse COO Resigns in Wake of Corporate Spying Scandal

Robins Kaplan LLP on

Top Tidjane Thiam ally Pierre-Olivier Bouee, Credit Suisse’s COO, has resigned in the wake of an internal probe finding that he “ordered the surveillance of the bank’s former wealth-management chief, Iqbal Khan, without...more

Hogan Lovells

FDA Finalizes Guidance on How to Determine Whether a Company Meets the “Small Business” Definition under the FSMA Preventive...

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) recently finalized its “Guidance for Industry: Determining the Number of Employees for Purposes of the ‘Small Business’ Definition in Parts 117 and 507 (CGMP and Preventive...more

Benesch

I’m Kind of a Big Dill: Current Challenges in Transporting Food Under FSMA

Benesch on

Since the U.S. Food and Drug Administration (“FDA”)’s publication of the Final Rule regarding Sanitary Transportation of Human and Animal Food on April 6, 2016, 21 CFR 1.900, et seq. (the “STF Rule”), there has been an...more

Holland & Knight LLP

EPA's New Prescription for Pharmaceutical Waste

Holland & Knight LLP on

• The U.S. Environmental Protection Agency (EPA) has published a new rule to address the handling, storage, transportation and disposal of hazardous waste pharmaceuticals by healthcare facilities and reverse distributors. •...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

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

Manatt, Phelps & Phillips, LLP

Agreement Reached on Bipartisan Federal GMO Food Labeling Bill

Provides Practical, Mandatory Disclosure and Preempts State GMO Labeling Laws - Senate Agriculture Committee leaders reached agreement June 23, 2016, on a bill that would require food containing genetic material modified...more

Benesch

InterConnect - Summer 2016

Benesch on

On April 6, 2016, the Food and Drug Administration (FDA) published its Final Rule on the Sanitary Transportation of Human and Animal Food (the Final Rule). These long-awaited regulations were mandated by the Food Safety...more

K&L Gates LLP

Vermont Act 120 and Beyond: Genetically Engineered Foods, Where Are We Now?

K&L Gates LLP on

On July 1, 2016, Vermont’s genetically engineered food labeling law is set to become effective. Act 120 and its implementing rule (Vermont Consumer Protection Rule 121) require food manufacturers to label food products that...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

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