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Regulatory Reform › Deregulation › Medical Devices

Parker Poe Adams & Bernstein LLP

OSHA Proposes Eliminating Medical Evaluation Requirement for Some Respirators

Parker Poe Adams & Bernstein LLP on

As part of its deregulatory initiative on July 1, the federal Occupational Safety and Health Administration proposed deleting requirements for medical evaluations before employees are permitted to use certain classes of...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in the Third Quarter of 2025 and Beyond

Goodwin on

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

Hogan Lovells

FDA loosens restrictions on gynecologic power morcellators, recommends use only with containment

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) today released significant changes to its recommendations for the use of laparoscopic power morcellators in gynecologic procedures, including an update to safety communications...more

Wilson Sonsini Goodrich & Rosati

FDA Reduces Regulatory Burden for Certain Medical Image Analyzers

Wilson Sonsini Goodrich & Rosati on

The U.S. Food and Drug Administration (FDA) had regulated medical image analyzers for more than 20 years under the agency’s most stringent regulatory requirements. But the agency recently reclassified a subset of these device...more

Hogan Lovells

Congress passes FY 2020 funding bill with tax benefits for energy, health care, and retirement plans

Hogan Lovells on

In a rare display of bipartisanship, after intense last minute negotiations between congressional leadership and the Executive Branch, President Donald Trump signed into law legislation passed last week by Congress to...more

Polsinelli

FDA Guidance on Software as Medical Devices Represents Broader Deregulation Trend

Polsinelli on

The FDA recently published two draft guidance documents to clarify which types of medical software, based on their functionality, are no longer considered medical devices as a result of the changes imposed under section 3060...more

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