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Medical Devices › Over The Counter Derivatives (OTC)

Sheppard Mullin Richter & Hampton LLP

FDA Revisits and Updates Guidance on Addressing Misinformation – Ten Years Later

Sheppard Mullin Richter & Hampton LLP on

On July 8, the U.S. Food and Drug Administration (“FDA”) announced its updated guidance, “Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers,” which provides recommendations and...more

MoFo Life Sciences

Non-Lab Diagnostics: FDA Regulatory Considerations

MoFo Life Sciences on

The advent of the COVID-19 rapid antigen test launched at-home diagnostics to the forefront of conversation in the life sciences industry. Many believe this is only the beginning. As the share of telehealth services...more

Sheppard Mullin Richter & Hampton LLP

FDA Appointment Signals Increased Attention on Medical Device Cybersecurity

Sheppard Mullin Richter & Hampton LLP on

At the beginning of February, the US Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) appointed Professor Kevin Fu as the first ever Acting Director of Medical Device Cybersecurity. Fu’s...more

Mintz - Health Care Viewpoints

Medical Products & FDA: What to Watch for in 2019

Mintz - Health Care Viewpoints on

Major legislation impacting FDA often accompanies user fee reauthorizations every 5 years. However, Congress has acted to address public health issues between user fee cycles. FDA regulates 20¢ of every U.S. consumer dollar...more

Hogan Lovells

User Fee Reauthorization Bill Includes Legislation Proposed to Improve Medical Device Regulation

Hogan Lovells on

Last week, the Senate Committee on Health, Education, Labor and Pensions (HELP Committee) advanced the Food and Drug Administration (FDA) Reauthorization Act of 2017 (S. 934), by a vote of 21–2. ...more

Alston & Bird

A&B Healthcare Week in Review

Alston & Bird on

I. REGULATIONS, NOTICES, & GUIDANCE - On April 4, 2016, the Centers for Medicare & Medicaid Services (CMS) issued the Final Calendar Year (CY) 2017 Medicare Advantage Capitation Rates and Medicare Advantage (MA) and...more

Mintz - Consumer Product Safety Viewpoints

Does CPSC or FDA Have Jurisdiction Over Your Consumer Product?

Mintz - Consumer Product Safety Viewpoints on

As our readers know, we write about legal developments that affect companies involved in manufacturing, importing, distributing, and/or selling “consumer products.” In many cases, these products fall squarely within the...more

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