News & Analysis as of

Centers for Medicare & Medicaid Services (CMS) Food and Drug Administration (FDA) Clinical Laboratory Testing

McDermott+

It’s Raining Regs: CMS Releases Major Laboratory-Developed Test Reg in Midst of Massive Reg Storm

McDermott+ on

Over the last several weeks, the Biden administration has released numerous final regulations in order to “beat the clock” before it ticks down to the Congressional Review Act (CRA) deadline. The CRA authorizes Congress to...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in Q2 2024 and Beyond

Goodwin on

As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more

Nelson Mullins Riley & Scarborough LLP

FDA Proposes Drastic Overhaul of Laboratory Developed Test Regulation

Of particular interest to clinical laboratories and medical device manufacturers, the U.S. Food and Drug Administration (FDA or the Agency) released a controversial proposed rule on September 29 that would dramatically alter...more

McDermott Will & Emery

[Webinar] 2021 +Dx Diagnostics Forum - April 6th, 12:00 pm - 3:30 pm EST

McDermott Will & Emery on

Celebrating its sixth program, McDermott+Consulting’s +Dx Diagnostics Forum is the premier annual program for the laboratory diagnostics community. Gain insight into how the industry addresses regulatory and business...more

Mintz - Health Care Viewpoints

An Update on FDA’s Contribution to COVID-19 Diagnostic Testing

Back in the early days of the COVID-19 pandemic, we published a post outlining the different kinds of diagnostic tests that were being marketed and the different roles of the two main federal regulators that oversee the...more

Foley & Lardner LLP

COVID-19: Ten Things to Know about Laboratory Testing

Foley & Lardner LLP on

Laboratory testing is a key factor in identifying or diagnosing COVID-19 patients, including during the asymptomatic phase, and determining appropriate treatment. With respect to COVID-19, laboratory testing is also critical...more

Morgan Lewis

Staying Within the Legal Lane: Providing Products and Services for COVID-19

Morgan Lewis on

Companies marketing products or services for coronavirus (COVID-19) should be aware of key areas of healthcare law and regulation, including Food and Drug Administration regulation, clinical laboratory testing oversight,...more

Akin Gump Strauss Hauer & Feld LLP

New CMS National Coverage Determination and FDA Regulatory Approach: the Next Generation for NGS Testing Policy?

• The new national Medicare coverage determination covers only FDA-authorized NGS tests with companion diagnostic indications, leaving NGS cancer tests without that specific indication to seek coverage from local Medicare...more

Mintz

What’s Lurking in Your Lab? Legal Risks for Hospital Laboratories

Mintz on

Most health-care lawyers are accustomed to monitoring the high profile areas of regulatory enforcement in health care. However, many hospital lawyers, whether in-house or outside counsel, are unaware of the potential...more

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