Wil Henderson on Manufacturers

Safe harbor for voluntary corrections of drug or device “misinformation” clarified in FDA guidance

The U.S. Food and Drug Administration (FDA) issued the revised draft guidance, “Addressing Misinformation About Medical Devices and Prescription Drugs,” which clarifies how firms can address misinformation about their...more

7/18/2024 / Food and Drug Administration (FDA) , Manufacturers , Medical Devices , Pharmaceutical Industry , Prescription Drugs

U.S. device makers get 2 years to comply with FDA Quality Management System Regulations final rule

The U.S. Food and Drug Administration (FDA) published its long-awaited final rule to amend the Quality System Regulation’s (QSR’s) current good manufacturing practice (CGMP) requirements for medical devices. The final rule...more

2/7/2024 / FDA Approval , Food and Drug Administration (FDA) , Life Sciences , Manufacturers , Medical Devices

“Remanufacturing” or “Servicing”? New FDA guidance clarifies distinction for medical devices

On June 18, 2021, the U.S. Food and Drug Administration (FDA) issued the draft guidance “Remanufacturing of Medical Devices,” which aims to help clarify the point when manipulation or repair of a medical device becomes...more

6/23/2021 / Comment Period , Cybersecurity , Data Security , Draft Guidance , Food and Drug Administration (FDA) , Manufacturers , Medical Devices , OEM

FDA updates VMSRP instructions for summary MDR reporting – including reasons for possible program exclusion

Last week, the U.S. Food and Drug Administration (FDA) updated the information regarding its Voluntary Malfunction Summary Reporting Program (VMSRP) on the FDA Medical Device Reporting (MDR) web page....more

10/7/2020 / Food and Drug Administration (FDA) , Healthcare Reform , Life Sciences , Manufacturers , Medical Devices , Pharmaceutical Industry , Product Defects , Regulatory Requirements , Reporting Requirements

FDA updates FAQ on COVID-19 tests and validation

Last week, on 23-25 June 2020, the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) updated the responses to six of the Frequently Asked Questions related to laboratories and...more

6/30/2020 / CDRH , Clinical Laboratories , Coronavirus/COVID-19 , Diagnostic Tests , Emergency Use Authorization (EUA) , Food and Drug Administration (FDA) , Manufacturers , Virus Testing

MDR single report exemption and ASRs: Coming to an end for most reporters

The Medical Device Reporting (MDR) regulation provides a mechanism for the U.S. Food and Drug Administration (FDA or the Agency), as well as medical device manufacturers, to identify and monitor adverse events (deaths,...more

1/15/2019 / Exemptions , Failure to Report , Food and Drug Administration (FDA) , Manufacturers , Medical Device Reports (MDRs) , Medical Devices , Regulatory Requirements

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. Although De Novo review has been available for two decades, for the past 20...more

12/13/2018 / 510(k) RTA , De Novo Standard of Review , FDA Approval , Food and Drug Administration (FDA) , Healthcare , Life Sciences , Manufacturers , Medical Devices , Pharmaceutical Industry , Standard of Review

Wil Henderson

Hogan Lovells

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