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Medical Devices 510(k) RTA Regulatory Requirements

Loeb & Loeb LLP

Illuminating the Risks: FDA Clearance Does Not Fully Shield Health & Wellness Devices from Advertising Scrutiny

Loeb & Loeb LLP on

The surge in health and wellness devices—including wearables, beauty devices and more—comes a result of consumer interest in preventive health measures. These products offer a range of benefits, from improving skin and...more

Morgan Lewis

Biden Administration Halts Proposal to Exempt Some Class II Devices Currently Subject to Enforcement Discretion from 510(k)...

Morgan Lewis on

In one of the last proposed notices from the US Department of Health and Human Services (HHS) under the Trump administration, HHS removed the 510(k) premarket notification requirement for seven types of gloves and proposed...more

Hogan Lovells

Regulatory Insights for Life Sciences and Health Care Investments: Medical Device and Technology

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Investing in the life sciences industry without an understanding of the key regulatory factors that could determine a product’s success or failure could cost you millions of dollars....more

Hogan Lovells

New draft guidance proposes a shift in how the FDA will evaluate certain device modifications

Hogan Lovells on

On September 28, 2018, the U.S. Food and Drug Administration (FDA or the Agency) issued a draft guidance document, entitled "The Special 510(k) Program," which, when finalized, will supersede the currently in effect Special...more

Knobbe Martens

FDA to Strengthen Cybersecurity Oversight

Knobbe Martens on

In a recent report, the U.S. Department of Health & Human Services (HHS) Office of the Inspector General (OIG) recommended that the U.S. Food & Drug Administration (FDA) include cybersecurity review as a greater part of the...more

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