On August 22, 2024, the U.S. Food and Drug Administration (FDA or Agency) issued a draft guidance entitled, Predetermined Change Control Plans for Medical Devices. The draft guidance describes how FDA plans to implement new...more
8/26/2024
/ 510(k) RTA ,
Applications ,
Artificial Intelligence ,
Draft Guidance ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Impact Assessments ,
Machine Learning ,
Medical Devices ,
Modification ,
Pre-Market Notification ,
Software
On April 29, 2024, the Food and Drug Administration (“FDA” or “the Agency”) released a pre-publication version of the highly anticipated laboratory developed test final rule (“LDT Final Rule”). The LDT Final Rule is...more
5/1/2024
/ Compliance ,
Enforcement ,
False Statements ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Final Rules ,
Food and Drug Administration (FDA) ,
Labeling ,
Medical Devices ,
Misleading Statements ,
Premarket Approval Applications ,
Proposed Rules ,
Public Health
On March 15, 2024, FDA published a white paper titled “Artificial Intelligence & Medical Products: How CBER, CDER, CDRH, and OCP are Working Together” (the AI White Paper) on the use of artificial intelligence (AI) across the...more
3/26/2024
/ Artificial Intelligence ,
CDRH ,
Center for Biological Diversity ,
Center for Biologics Evaluation and Research (CBER) ,
Center for Drug Evaluation and Research (CDER) ,
Department of Health and Human Services (HHS) ,
Food and Drug Administration (FDA) ,
Medical Devices ,
Popular ,
Public Health ,
Shareholders ,
White Papers
On February 2, 2024, the U.S. Food and Drug Administration (FDA) published a final rule amending the device good manufacturing practice (GMP) requirements of the Quality System Regulation (QSR) and harmonizing them with...more
On September 27, 2023, FDA finalized its guidance entitled “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions” (the “2023 Final Guidance”). The Final Guidance replaces...more
10/11/2023
/ Artificial Intelligence ,
Cybersecurity ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Final Guidance ,
Food and Drug Administration (FDA) ,
Homeland Security Cybersecurity & Infrastructure Security Agency (CISA) ,
Machine Learning ,
Medical Devices ,
NTIA ,
Popular ,
Premarket Approval Applications ,
Risk Management ,
Software ,
Source Code
On June 14, 2023, FDA finalized its “Content of Premarket Submissions for Device Software Functions: Guidance for Industry and Food and Drug Administration Staff” (the “2023 Final Guidance”). The Final Guidance replaces the...more
First mentioned in a 2019 discussion paper entitled “Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD),” the idea of a defined set of...more
On December 16, 2022, the U.S. Food & Drug Administration (“FDA” or “Agency”) published an important and noteworthy draft guidance document entitled “Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a...more
12/20/2022
/ Citations ,
Draft Guidance ,
FDARA ,
FDASIA ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Inspections ,
Manufacturers ,
Medical Devices ,
OSHA ,
Pharmaceutical Industry ,
Prescription Drugs
On September 29, 2022, the United States Government Accountability Office (“GAO”) and the National Academy of Medicine (“NAM”) jointly published a detailed Report to Congressional Requesters titled Artificial Intelligence in...more
On September 13, 2022 the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) jointly released a new draft guidance document titled “Computer Software Assurance for...more
10/4/2022
/ Center for Biologics Evaluation and Research (CBER) ,
CGMP ,
CVM ,
Draft Guidance ,
Food and Drug Administration (FDA) ,
Infrastructure ,
Manufacturers ,
Medical Devices ,
New Guidance ,
Software ,
Validation and Re-Validation Requirements
On April 8, 2022, FDA issued new, long-awaited draft guidance “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions” (Draft Cybersecurity Guidance). 1 This draft guidance...more
On February 23, 2022, the U.S. Food and Drug Administration (FDA) published in the Federal Register, 87 Fed. Reg. 10119, the long-awaited proposed rule, Medical Devices; Quality System Regulation Amendments (Docket No....more
3/2/2022
/ Australia ,
Canada ,
EU ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Inspections ,
International Standards ,
Japan ,
Medical Devices ,
Proposed Regulation ,
Proposed Rules
The International Electrotechnical Commission (IEC) and the International Organization for Standards (ISO) recently published a cybersecurity standard that has received limited press but may have a significant impact on...more
On November 4, 2021, FDA released a draft guidance for public comment entitled “Content of Premarket Submissions for Device Software Functions” (the “2021 Draft Guidance”). In its final form, this guidance will replace the...more
Earlier this week, FDA’s Center for Devices and Radiological Health (CDRH) announced the appointment of Professor Kevin Fu, Associate Professor at the University of Michigan, as the Center’s first Acting Director of Medical...more