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Medical Devices › Regulatory Agencies

Ropes & Gray LLP

FDA Commissioner Makary Promises “Real Time” Release of Complete Response Letters: Can FDA Really Do That?

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On July 10, 2025, in the name of embracing “radical transparency,” the U.S. Food and Drug Administration (“FDA”) announced that it was publishing more than 200 complete response letters (“CRLs”) issued in response to drug and...more

Hogan Lovells

FDA finalizes RRA manufacturing inspection guidance as US focuses on supply chain security

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The U.S. Food and Drug Administration (FDA) recently issued final guidance entitled “Conducting Remote Regulatory Assessments,” which explains the agency's plans to continue utilizing its records request authority and virtual...more

Mintz - Health Care Viewpoints

Health Law Diagnosed – Best Practices for Communicating with the FDA

Mintz - Health Care Viewpoints on

In the latest episode of Health Law Diagnosed , Of Counsel Bridgette Keller hosts a discussion of best practices for interacting and communicating with the FDA....more

Venable LLP

Venable FDA Pulse: FDA at the 100-Day Mark of Trump Administration 2.0

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Since returning to office for a second term, President Trump has taken steps to reshape federal agencies. Here, we discuss the significant changes that have occurred at the Food and Drug Administration (FDA or Agency) during...more

King & Spalding

FDA's LDT Rule Struck Down by Court: FDA Has Lost the Battle, But Is the War Over?

King & Spalding on

A court has struck down the Food and Drug Administration’s attempt to extend its regulatory authority to clinical laboratory testing services. On March 31, 2025, in the consolidated cases American Clinical Laboratory...more

McDermott Will & Schulte

UK Medical Device Regulator Proposes a 12 Month Delay for UKCA Requirements and the New Medical Device Regulations

McDermott Will & Schulte on

On Friday 21st October 2022, the Medicines and Healthcare Products Regulatory Agency (MHRA) wrote to the medical device industry to explain its intention: - To extend the current standstill period by twelve months from...more

Hogan Lovells

CRO Engagement: A compliance checklist to identify red flags and prevent bribery compliance risks

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The engagement of Clinical Research Organizations (CROs) by pharmaceutical and medical device companies to manage some or all of their clinical trial-related duties and functions is becoming more and more relevant as the...more

Mintz - ML Strategies

What You Need to Know: State and Federal Updates Related to COVID-19

Mintz - ML Strategies on

...On Monday, House Speaker Nancy Pelosi, Majority Whip James Clyburn, Transportation & Infrastructure Committee Chairman Peter DeFazio, and Energy & Commerce Committee Chairman Frank Pallone held a press conference on a...more

McDermott Will & Schulte

US Office of Management and Budget Issues a Memorandum Calling for Agency Plans From Federal Government Agencies

McDermott Will & Schulte on

On January 7, 2020, the Director of the US Office of Management and Budget (OMB) issued a Draft Memorandum (the Memorandum) to all federal “implementing agencies” regarding the development of regulatory and non-regulatory...more

Hogan Lovells

[Webinar] Health Care and the Internet of Things: New Regulatory Developments - July 25th, 2:00pm EDT

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Please join the Hogan Lovells Communications and FDA practices on Thursday, July 25th for our webinar, Health Care and the Internet of Things: New Regulatory Developments. We will explore new policy initiatives and...more

Hogan Lovells

UK MHRA consults on no-deal Brexit legislation

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The UK Medicines and Healthcare products Regulatory Agency (MHRA) has initiated a consultation on the legislation and regulatory processes for medicines, medical devices and related clinical trials that would need to be...more

Hogan Lovells

UK publishes paper on Brexit and medicines regulation

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On the same day as the European Council voted to move the European Medicines Agency (EMA) from London to Amsterdam, the UK Parliament issued a briefing paper on Brexit and medicines regulation. ...more

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