Recently, it was reported that the U.S. Food and Drug Administration (FDA) is launching two cross-agency artificial intelligence (AI) councils. One AI council will be tasked with addressing how the agency uses AI internally...more
On December 30, 2024, FDA unveiled an Idea Lab as part of its Home as a Health Care Hub initiative to reimagine how new and existing medical devices can be incorporated in a home environment. As previously discussed here, FDA...more
Today FDA issued final guidance to provide recommendations for predetermined change control plans (PCCPs) tailored to artificial intelligence (AI) enabled device software functions. FDA recognizes that development of...more
Researchers from the National Institutes of Health (NIH) have developed an algorithm that harnesses AI to help accelerate the process of matching potential volunteers for relevant clinical research trials. The algorithm,...more
AdvaMed, the world’s largest medical technology association representing device, diagnostics and digital technology companies, released a white paper that reviews the current landscape of artificial intelligence (AI)-based...more
On September 26, 2024, FDA published a compilation of commonly used terms in the digital health, artificial intelligence (AI), and machine learning space and their definitions, available here. FDA intends the glossary to be...more
Multiple policy documents relating to software and digital health have been issued by the U.S. Food and Drug Administration (FDA). The documents offer: a framework for the use of digital health tools in the context of drug...more
In recent days, the U.S. Food and Drug Administration (FDA) has issued multiple policy documents relating to software and digital health. Two of them relate to software-based medical devices: draft guidance for predetermined...more
In a break with past precedent, last year’s Food and Drug Administration (FDA) user fee reauthorization legislation did not contain significant FDA policy changes. Although the Senate Health, Education, Labor and Pensions...more
FDA Also Issues Report on Software Pre-Cert Pilot, Leaving Unanswered Questions on Future of Software Regulation -
Key Points -
The Final Guidance does not address the FDA’s risk-based enforcement discretion policy...more
On May 17 the Senate Health, Education, Labor and Pensions (HELP) Committee released a bipartisan legislative discussion draft of the Food and Drug Administration (FDA) Safety and Landmark Advancements Act (FDASLA), which...more
In vitro diagnostics (IVD) reform re-entered the legislative fray this week. The Verifying Accurate Leading-edge IVCT Development Act of 2021 (the “VALID Act of 2021,” the “VALID Act” or the “Act”) was introduced in both the...more
• The FDA recently issued six guidance documents that further clarify the agency’s interpretation of the 21st Century Cures Act’s software exemptions.
• The revised draft guidance on CDS further elaborates on how to make CDS...more
10/8/2019
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International Medical Device Regulators Forum (IMDRF) ,
Medical Devices ,
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Popular ,
Public Comment ,
Regulatory Requirements ,
Software Developers
• On July 29, 2019, CMS released its proposed 2020 Physician Fee Schedule rule, which includes the much anticipated proposed regulatory changes to the Sunshine Act/Open Payments program (“Open Payments”). The proposed...more
8/5/2019
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Comment Period ,
Disclosure Requirements ,
Health Care Providers ,
Manufacturers ,
Medical Devices ,
Nurse Practitioners ,
Nurses ,
Open Payments ,
Pharmaceutical Industry ,
Physicians ,
Proposed Rules ,
Public Comment ,
Reporting Requirements ,
Sunshine Act
• In a recent warning letter, the Food and Drug Administration (FDA) advised a laboratory to seek marketing authorization for its genetic tests that qualified as laboratory developed tests (LDTs)—which have largely benefited...more
5/14/2019
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Enforcement Actions ,
FDA Warning Letters ,
Food and Drug Administration (FDA) ,
Genetic Testing ,
Health Care Providers ,
Labeling ,
Laboratory Developed Tests ,
Life Sciences ,
Marketing ,
Medical Devices
• FDA has released a white paper outlining a potential regulatory framework for software as a medical device (SaMD) that leverages artificial intelligence (AI) or machine learning (ML).
• The white paper distinguishes three...more
Among the flurry of policies the Food and Drug Administration (FDA) released in the waning days of the Obama administration are several documents that seek to clarify the agency’s positions on communications about medical...more
Key Points -
- Although the Cures medical software provisions largely align with FDA's current policies, certain of the Cures exemptions may be broader than those under current agency policy.
- Many clinical...more
Key Points -
- The 21st Century Cures Act (“Cures” or the “Act”) significantly impacts FDA’s review and approval of medical devices, and how medical devices are covered and paid for.
- These new authorities...more
If you read one thing...
- FDA released Draft Guidance outlining steps for medical device manufacturers to ensure cybersecurity of medical devices already on the market; comments are due by April 21, 2016.
-...more