The U.S. Food and Drug Administration (FDA) recently revised its final guidance, How to Prepare a Pre-Request for Designation (Pre-RFD). ...more
11/17/2025
/ Biologics ,
Biotechnology ,
Clinical Trials ,
Food and Drug Administration (FDA) ,
Healthcare ,
Medical Devices ,
New Guidance ,
Pharmaceutical Industry ,
Regulatory Authority ,
Regulatory Oversight ,
Regulatory Requirements ,
Research and Development
As part of the Hogan Lovells Horizons 2025 life sciences event series, our cross-practice team recently gathered in Boston to discuss shifting regulatory paradigms under the Trump administration's Food and Drug Administration...more
10/22/2025
/ Artificial Intelligence ,
Center for Drug Evaluation and Research (CDER) ,
Enforcement Actions ,
Food and Drug Administration (FDA) ,
Healthcare ,
Inspections ,
Life Sciences ,
Manufacturers ,
Medical Devices ,
Onshoring ,
Pharmaceutical Industry ,
Regulatory Oversight ,
Trump Administration
The U.S. Food and Drug Administration (FDA) recently announced a Request for Public Comment on the evaluation of devices that integrate artificial intelligence (AI), including generative AI (GenAI)-enabled technology. FDA's...more
10/9/2025
/ Artificial Intelligence ,
Comment Period ,
Digital Health ,
Food and Drug Administration (FDA) ,
Healthcare ,
Innovative Technology ,
Life Sciences ,
Machine Learning ,
Medical Devices ,
Public Comment ,
Regulatory Agenda ,
Regulatory Oversight ,
Regulatory Requirements ,
Risk Management
The U.S. Food and Drug Administration (FDA) recently issued final guidance entitled “Conducting Remote Regulatory Assessments,” which explains the agency's plans to continue utilizing its records request authority and virtual...more
The U.S. Food and Drug Administration (FDA) recently finalized its March 2024 select updates to its guidance "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions” (“Premarket...more
On May 29, 2025, the U.S. Food and Drug Administration (FDA) issued a final version of its guidance “Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program,” offering an expanded framework...more
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
Last week, the U.S. Food and Drug Administration (FDA) proposed two new rules for classification of certain, previously unclassified wound dressings and liquid wound washes containing antimicrobials, which would categorize...more
The U.S. Food and Drug Administration (FDA) has finalized its guidance on “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions,” which advises medical device manufacturers on...more
The U.S. Food and Drug Administration (FDA) published an updated final guidance on the use of International Standard ISO 10993-1, “Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk...more
The U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) has issued three new draft guidances as part of an effort to modernize its 510(k) Program for new products that can be found...more
The U.S. Food and Drug Administration (FDA) recently issued the final guidance, Content of Premarket Submissions for Device Software Functions, which provides an updated framework by which sponsors should determine the...more
The U.S. Food and Drug Administration (FDA) recently issued the draft guidance “Select Updates for the Breakthrough Devices Program Guidance: Reducing Disparities in Health and Health Care,” which proposes updates to the...more
The U.S. Food and Drug Administration (FDA) has finalized its guidance “Electronic Submission Template for Medical Device 510(k) Submissions,” which will require medical device 510(k) submissions to use FDA’s electronic...more
On July 25, 2022, the U.S. Food and Drug Administration (FDA) issued final guidance on Unique Device Identification (UDI) compliance date policies, stating that the agency will not enforce a requirement that manufacturers of...more
The COVID-19 Report is a compilation of coronavirus news, analysis, and insights from around the world to help life sciences and health care companies stay current in this challenging time. In this week's Report: Woodcock...more
On December 22, 2021, the U.S. Food and Drug Administration (FDA) published two draft guidance documents intended to help medical device manufacturers transition out of the temporary rules put in place for the duration of the...more
Yesterday, the U.S. Food and Drug Administration (FDA) shared online its list of artificial intelligence and machine learning (AI/ML)-enabled devices that are legally marketed in the U.S. (via 510(k) clearance, De Novo...more
Last week, the U.S. Food and Drug Administration (FDA) issued a safety communication to remind patients and health care providers that the safety and effectiveness of robotically-assisted surgical (RAS) devices for use in...more
On January 6, 2021, the U.S. Food and Drug Administration (FDA) published a final guidance outlining the Safer Technologies Program (STeP) for Medical Devices: a voluntary program for medical devices and device-led...more
Tuesday, 20 October 2020 -
President Trump’s executive order on essential medicines aims to encourage pharmaceutical companies to bring their manufacturing back to the U.S. But it may also have unintended consequences for...more
10/20/2020
/ CDRH ,
Coronavirus/COVID-19 ,
Dr. Anthony Fauci ,
Emergency Use Authorization (EUA) ,
Executive Orders ,
Financial Stimulus ,
Food and Drug Administration (FDA) ,
Government Lockdown ,
Infectious Diseases ,
Life Sciences ,
Medical Devices ,
Pharmaceutical Industry ,
Relief Measures ,
Supply Chain ,
Trump Administration
On October 16, the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) announced the list of priority guidance documents that CDRH intends to publish this fiscal year (FY-2021)....more
The COVID-19 Report is a compilation of coronavirus news, analysis, and insights from around the world to help life sciences and health care companies stay current in this challenging time.
...more
9/29/2020
/ CDRH ,
Centers for Disease Control and Prevention (CDC) ,
Emergency Use Authorization (EUA) ,
Food and Drug Administration (FDA) ,
Intended Use ,
Life Sciences ,
Manufacturers ,
Medical Devices ,
Pharmaceutical Industry ,
Regulatory Reform ,
Trump Administration ,
Virus Testing
In Tuesday's Report: Germany clarifies restrictions on dispensing in-vitro diagnostic kits, UK partners with Valneva on vaccine production, U.S. CDC reverts to older guidance, HHS bars health agencies from signing new rules,...more
Our Medical Device and Technology team has been at the forefront of the COVID-19 legal response since the pandemic swept across the globe. In just a few short months, our team has taken on nearly 200 matters, ranging from...more