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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.
News
12 April 2023
On March 30, the U.S. Food and Drug Administration (FDA) published draft guidance that proposes recommendations on the types of information that should be included in a Predetermined Change ...
News
14 June 2022
Hogan Lovells partners Kelliann H. Payne and John J. Smith, M.D., J.D. recently joined Richard Frank, MD, PhD, Chief Medical Officer, Siemens Healthineers, and other industry leaders in...
News
22 January 2021
On January 15, the U.S. Department of Health and Human Services (HHS) published a notice and request for information (RFI) proposing to exempt 91 medical devices – for which the...
News
15 January 2021
On January 12, the U.S. Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) Digital Health Center of Excellence released its new five-part...
Insights and Analysis
09 March 2020
Recent data from the U.S. Food and Drug Administration (FDA or the agency) on the percentage of De Novo classification requests that are declined or withdrawn raises questions about the...
Insights and Analysis
27 January 2020
On 22 January 2020 the U.S. Food and Drug Administration (FDA or the agency) published three regulations formally classifying certain radiological image analyzers and related software,...
News
18 October 2019
On September 28, 2018, the U.S. Food and Drug Administration (FDA or the Agency) issued a draft guidance document, entitled "The Special 510(k) Program," which, when finalized,...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
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."
News
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.
