Blake Wilson on Regulatory Requirements

FDA updates medical device user fee guidance for small businesses, tightening some rules for reductions and waivers

On July 31, 2025, the U.S. Food and Drug Administration (FDA) issued its final guidance document “Medical Device User Fee Small Business Qualification and Determination,” which supersedes its previous guidance document dated...more

8/18/2025 / Final Guidance , Food and Drug Administration (FDA) , Medical Devices , Regulatory Requirements , Small Business

Federal court vacates FDA Laboratory Developed Test rule

Yesterday, the U.S. District Court for the Eastern District of Texas vacated the U.S. Food and Drug Administration’s 2024 rule that aimed to regulate laboratory-developed tests (LDTs) as medical devices, deciding it is...more

4/2/2025 / Food and Drug Administration (FDA) , Laboratory Developed Tests , Medical Devices , Regulatory Authority , Regulatory Requirements

FDA warns of “important” clinical trial protocol deviations

The U.S. Food and Drug Administration (FDA) published the draft guidance “Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices,” which provides advice for sponsors, investigators, and...more

1/14/2025 / Clinical Trials , Data Management , Food and Drug Administration (FDA) , Life Sciences , Medical Devices , Regulatory Oversight , Regulatory Requirements , Reporting Requirements , Risk Management

First company receives FDA violation notice for ClinicalTrials.gov submission omission

On April 27, 2021, the U.S. Food and Drug Administration (FDA) issued its first Notice of Noncompliance to a company for failing to submit required clinical trial summary results information to ClinicalTrials.gov. In...more

4/29/2021 / Clinical Trials , Enforcement Actions , Federal Food Drug and Cosmetic Act (FFDCA) , Filing Requirements , Food and Drug Administration (FDA) , Noncompliance , Pharmaceutical Industry , Public Health Service Act , Regulatory Requirements , Statutory Violations

New draft guidance proposes a shift in how the FDA will evaluate certain device modifications

On September 28, 2018, the U.S. Food and Drug Administration (FDA or the Agency) issued a draft guidance document, entitled "The Special 510(k) Program," which, when finalized, will supersede the currently in effect Special...more

10/10/2018 / 510(k) RTA , Draft Guidance , Food and Drug Administration (FDA) , Medical Devices , Pharmaceutical Industry , Regulatory Oversight , Regulatory Requirements

Blake Wilson

Hogan Lovells

Popular Topics by This Author

Latest Posts › Regulatory Requirements

FDA updates medical device user fee guidance for small businesses, tightening some rules for reductions and waivers

Federal court vacates FDA Laboratory Developed Test rule

FDA warns of “important” clinical trial protocol deviations

First company receives FDA violation notice for ClinicalTrials.gov submission omission

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

Blake Wilson

Hogan Lovells

Popular Topics by This Author

Latest Posts › Regulatory Requirements

FDA updates medical device user fee guidance for small businesses, tightening some rules for reductions and waivers

Federal court vacates FDA Laboratory Developed Test rule

FDA warns of “important” clinical trial protocol deviations

First company receives FDA violation notice for ClinicalTrials.gov submission omission

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

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