Representative experience

We have lawyers on the Best Lawyers of America List, The Legal 500, ranked Chambers USA top Healthcare: Pharmaceutical/Medical Products Regulatory practices, and Washington D.C. Super Lawyers list.

We have lawyers who have been the LMG Life Science’s Life Sciences Star and on International Who’s Who of Life Science Lawyers.

Hogan Lovells Publications

Final guidance provides additional clarity to the Humanitarian Device Exemption program Medical Device Alert

10 September 2019

On 6 September 2019 the U.S. Food and Drug Administration (FDA or the agency) issued its final guidance document entitled "Humanitarian Device Exemption (HDE) Program."

Hogan Lovells Publications

De Novo requests: FDA releases updated RTA checklist Medical Device Alert

09 September 2019

On 9 September 2019 the U.S. Food and Drug Administration (FDA or the agency) issued its final guidance document entitled "Acceptance Review for De Novo Classification Requests."

Hogan Lovells Publications

Uncertainty remains: FDA releases new benefit-risk decision tree for medical device PMAs and De Novos in concert with final uncertainty guidance Medical Device Alert

05 September 2019

On 30 August 2019 the U.S. Food and Drug Administration (FDA or the agency) issued a final guidance document entitled "Consideration of Uncertainty in Making Benefit-Risk Determinations in...

Hogan Lovells Publications

An intelligent approach for regulating medical device AI Medical Device Alert

05 April 2019

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...

Hogan Lovells Publications

In the midst of government shutdown, FDA pushes ahead with 510(k) modernization Medical Device Alert

24 January 2019

Thirty-two days into the longest government shutdown in U.S. history, the Food and Drug Administration (FDA or the agency) announced two developments signaling further headway toward...

Hogan Lovells Publications

FDA releases final guidance document on PMA manufacturing site change supplements Medical Device Alert

20 December 2018

On 17 December 2018 the U.S. Food and Drug Administration (FDA) issued a final guidance document intended to help manufacturers determine the appropriate premarket approval (PMA)...

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Key contacts

Janice M. Hogan

Partner
Philadelphia, Washington, D.C.

Jonathan S. Kahan

Partner
Washington, D.C.

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Premarket Review

Representative experience

Final guidance provides additional clarity to the Humanitarian Device Exemption program Medical Device Alert

De Novo requests: FDA releases updated RTA checklist Medical Device Alert

Uncertainty remains: FDA releases new benefit-risk decision tree for medical device PMAs and De Novos in concert with final uncertainty guidance Medical Device Alert

An intelligent approach for regulating medical device AI Medical Device Alert

In the midst of government shutdown, FDA pushes ahead with 510(k) modernization Medical Device Alert

FDA releases final guidance document on PMA manufacturing site change supplements Medical Device Alert

Key contacts

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