The U.S. Food and Drug Administration (FDA) has published final guidance on “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products” (SIUU...more
On January 7, 2024, the U.S. Food and Drug Administration (FDA) published the draft guidance “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations,” which...more
1/15/2025
/ Artificial Intelligence ,
Cybersecurity ,
Data Management ,
Draft Guidance ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Machine Learning ,
Medical Devices ,
Regulatory Requirements ,
Risk Assessment ,
Risk Management ,
Software
Amid continued rapid development of novel software products that present new opportunities in the health care space, FDA has yet to grant marketing authorization to a medical device incorporating artificial intelligence (AI)...more
Last week, the U.S. Food and Drug Administration (FDA) finalized guidance on the types of information that should be included in a Predetermined Change Control Plan (PCCP) as part of a marketing submission for an artificial...more
The U.S. Food and Drug Administration (FDA) has published new draft guidance on “Predetermined Change Control Plans for Medical Devices,” which describes the process by which device sponsors may seek FDA approval for...more
The U.S. Food and Drug Administration (FDA) issued the revised draft guidance, “Addressing Misinformation About Medical Devices and Prescription Drugs,” which clarifies how firms can address misinformation about their...more
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
Products incorporating artificial intelligence/machine learning (AI/ML) algorithms have enormous potential for health care. The power of AI can enhance the capabilities of software that has the potential to benefit more...more
On March 30, the U.S. Food and Drug Administration (FDA) published draft guidance that proposes recommendations on the types of information that should be included in a Predetermined Change Control Plan (PCCP) in a marketing...more
In the waning days of FDA’s fiscal year, the U.S. Food and Drug Administration (FDA) issued the greatly anticipated final guidance “Clinical Decision Support Software,” which aims to clarify the scope of the FDA’s oversight...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
On August 2, 2021, the U.S. Food and Drug Administration (FDA) published a final rule to amend its “intended use” regulations, codified at 21 CFR § 801.4 for medical devices and 21 CFR § 201.128 for drugs. This updated final...more
8/5/2021
/ Federal Food Drug and Cosmetic Act (FFDCA) ,
Final Rules ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Intended Use ,
Life Sciences ,
Manufacturers ,
Medical Devices ,
Off-Label Use ,
Physicians ,
Product Labels
On April 16, the U.S. Department of Health and Human Services (HHS) and Food and Drug Administration (FDA) published a notice of withdrawal of their January 15 proposal to exempt 84 medical device types ...more
On September 23, the U.S. Food and Drug Administration (FDA) published a proposed rule to modify its intended use regulations to clarify the types of evidence FDA will consider when determining the “intended use” of a medical...more
On September 9, the U.S. Food and Drug Administration (FDA) updated its online FAQs, entitled “Adverse Event Reporting for Medical Devices Under Emergency Use Authorization (EUA) or Discussed in COVID-19-Related Guidance...more
9/11/2020
/ Adverse Events ,
Coronavirus/COVID-19 ,
Emergency Use Authorization (EUA) ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Infectious Diseases ,
Manufacturers ,
Medical Devices ,
Medical Supplies ,
Pharmaceutical Industry ,
Regulatory Requirements ,
Reporting Requirements ,
Suppliers ,
Supply Chain
On Monday, the FDA published the draft guidance, “Type V DMFs for CDER-Led Combination Products Using Device Constituent Parts With Electronics or Software,” which could facilitate drug manufacturers’ ability to integrate...more
From analysis of medical imaging such as echocardiograms, computed tomography (CT), endoscopy, and skin photographs, to tissue histology and physiological data such as electrocardiograms (ECG), these technologies have...more
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
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
On June 12, FDA finalized two guidance documents regarding the types of information that drug and device manufacturers may communicate to payors and that the agency regards as “consistent with" FDA-required labeling. FDA...more
Last week, FDA released updates to its Software Precertification (Pre-Cert) Pilot Program, including release of a working model reflecting the Agency's vision of the pilot and outlining its most critical components. The...more
With the continued explosion of software and software-controlled medical devices, including the growing use of machine learning and artificial intelligence, the FDA (the Agency) Medical Device Safety Action Plan (the Plan)...more
4/26/2018
/ Connected Items ,
Cybersecurity ,
Data Breach ,
Food and Drug Administration (FDA) ,
Medical Devices ,
Patient Safety ,
Personal Data ,
Pharmaceutical Industry ,
Popular ,
Regulatory Standards ,
Risk Management
On January 17, 2018, the U.S. Food and Drug Administration (FDA or the Agency) issued a proposed rule to update the framework for requesting internal agency supervisory review of certain decisions related to devices regulated...more
Six years after its first attempt to update its now 20-year-old guidelines for when modifications to a 510(k)-cleared device require the submission of a new 510(k) notice, the U.S. Food and Drug Administration (FDA or the...more
Recognizing both the opportunities and the potential regulatory challenges presented by such rapid development, the FDA – under the leadership of recently confirmed Commissioner Dr. Scott Gottlieb – is spearheading a new...more