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Across topics and issues, borders and industries, we have the thought leadership you need to stay ahead of changes in the law.

Across topics and issues, borders and industries, we have the thought leadership you need to stay ahead of changes in the law.

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Publications

News

In midst of COVID-19, FDA reminds industry that it plays both good and bad cop

U.S. authorities are actively policing entities making illegal promotional claims that products mitigate, prevent, treat, cure, or diagnose COVID-19. To date, seven Warning Letters...

Published Works

Applying FDA's Rules in the new World of Online Marketing and Crowdfunding Regulatory Affairs Professionals Society

Suzanne Levy Friedman authored "Applying FDA's Rules in the new World of Online Marketing and Crowdfunding" that originally appeared inRAPSRegulatory Focus.

News

FDA may accept DMFs for electronics and software components of drug-led combination products

On Monday, the FDA published the draft guidance, “Type V DMFs for CDER-Led Combination Products Using Device Constituent Parts With Electronics or Software,” which could...

News

New draft guidance proposes a shift in how the FDA will evaluate certain device modifications

On September 28, 2018, the U.S. Food and Drug Administration (FDA or the Agency) issued a draft guidance document, entitled "The Special 510(k) Program," which, when finalized,...

News

Clarifying clinical decision support: FDA overhauls guidance to focus on risk

On 27 September 2019 the U.S. Food and Drug Administration (FDA or the agency) released the draft guidance entitled "Clinical Decision Support Software" (CDS guidance), which...

Hogan Lovells Publications

Our FDA Medical Device and Technology compliance team receives ISO 13485 auditor certification Medical Device and Technology Alert

Our team of compliance lawyers and regulatory science professionals has over 100 years combined experience working with medical device companies. To complement our extensive real-world,...

Hogan Lovells Publications

An intelligent approach for regulating medical device AI Medical Device Alert

Hogan Lovells has been at the forefront of advising our clients on the clearance or approval of an increasing number of software as a medical device (SaMD) products and other medical...

News

FDA proposes new regulations to govern De Novo requests – will the process live up to its promise?

Last week the Food and Drug Administration (FDA) issued a proposed set of new regulations to further define and update the De Novo review process[1]. Although De Novo review has been...

Published Works

Medical device crowdfunding and preapproval promotion: Where does FDA draw the line? Food and Drug Law Institute

The medical device industry has long sought more comprehensive guidance from the Food and Drug Administration (FDA or the agency) regarding the line between appropriate and inappropriate...

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