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Foley Hoag LLP

Fostering More Access to Medical Devices: FDA’s Efforts to Advance Health Equity

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On August 5, 2024, FDA’s Center for Devices and Radiological Health (CDRH) published a discussion paper entitled, “Discussion Paper: Health Equity For Medical Devices” (Discussion Paper), to aid in its efforts to advance...more

Jones Day

Vital Signs: Digital Health Law Update | Spring 2024

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Welcome to Vital Signs, a curated compilation of the latest legal and regulatory developments in digital health. Our lead article reports on recent developments in the U.S. Food and Drug Administration's ("FDA") regulatory...more

Epstein Becker & Green

FDA Oversight of AI Software Developed by Health Care Providers

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Introduction - Hardly a day goes by when we don’t see some media report of health care providers experimenting with machine learning, and more recently with generative AI, in the context of patient care. The allure is...more

Faegre Drinker Biddle & Reath LLP

The Omnibus Appropriations Act Grants FDA Formal Authority to Require Cybersecurity Action by Medical Device Manufacturers

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Cyberattacks affecting internet-connected medical devices like insulin pumps, intracardiac defibrillators, mobile cardiac telemetry, pacemakers and intrathecal pain pumps have increased in recent years. And such attacks show...more

Faegre Drinker Biddle & Reath LLP

Responsible AI: Managing Risk in an Evolving Regulatory and Legal Landscape

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Artificial Intelligence (“AI”) is driving innovation across industries and is playing an increasing role in everyday life. AI (and, more broadly, algorithms) is being used in diagnostics, enabled medical devices, device...more

MoFo Life Sciences

Rescinding The MCIT/R&N Final Rule, CMS Seeks New Approaches For Innovative Technology Coverage

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On November 12, 2021, the Centers for Medicare and Medicaid Services (CMS) issued a final rule rescinding the Medicare Coverage of Innovative Technology and Definition of “Reasonable and Necessary” final rule (MCIT/R&N). As...more

MoFo Life Sciences

CMS Proposes To Repeal MCIT Final Rule

MoFo Life Sciences on

Last week, the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule to repeal the Medicare Coverage of Innovative Technology (MCIT) and Definition of “Reasonable and Necessary” final rule (the “Proposed...more

Goodwin

Exactly One Year Later, CMS Reverses Course on Covering Innovative MedTech

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In September 2020, the Centers for Medicare & Medicaid Services (CMS) proposed a new rule that would expedite Medicare coverage for medical technology approved through the Food & Drug Administration’s (FDA’s) “Breakthrough...more

Hogan Lovells

CMS delays “reasonable and necessary” definition, expedited breakthrough device coverage process rule

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On March 17, 2021, the Centers for Medicare & Medicaid Services (CMS) published a notice in the Federal Register delaying the effective date of the final rule titled, “Medicare Program; Medicare Coverage of Innovative...more

Polsinelli

CMS Proposes Medicare Coverage Pathway for FDA-Designated Breakthrough Technologies

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On September 1st, the Centers for Medicare & Medicaid Services (CMS) proposed a rule offering medical device manufacturers Medicare coverage upon FDA clearance or approval when their products have been designated by the U.S....more

Skadden, Arps, Slate, Meagher & Flom LLP

Protecting Lives Without Destroying Jobs — Using Technology To Suppress COVID-19

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Many countries around the world are being forced to watch as the only tool they have to suppress COVID-19 — social distancing — causes unprecedented damage to their economies. Because suppression measures may be required...more

Sheppard Mullin Richter & Hampton LLP

New Set Of Guidance From FDA Provides Clarity On Digital Health Policies, Machine Learning

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On September 26, 2019, the US Food and Drug Administration (FDA) published six guidance documents clarifying its scope of authority and enforcement discretion policies in light of the 21st Century Cures Act (Cures Act). The...more

Hogan Lovells

FDA announces new expedited program for devices expected to significantly improve the safety of existing technologies

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On 19 September 2019 the U.S. Food and Drug Administration (FDA or the agency) released the draft guidance document entitled "Safer Technologies Program for Medical Devices" (STeP), effectively following through on the...more

Hogan Lovells

FDA announces planned modernization of 510(k) pathway and seeks a more active role in driving technological innovation

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On 26 November 2018 Food and Drug Administration (FDA) Commissioner Scott Gottlieb and Center for Devices and Radiological Health (CDRH) Director Jeffrey Shuren issued a joint statement proposing to rebrand and modernize the...more

Knobbe Martens

FDA Launches 'Quik' 510(k) Review Pilot Program

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The Food and Drug Administration (FDA) recently unveiled the Quality in 510(k) (“Quik”) Review pilot program, aimed at reducing the time it takes to review moderate-risk medical devices by one-third. The pilot, dubbed as “a...more

Knobbe Martens

FDA Expresses Priorities for Clinical Trial Efficiency, Artificial Intelligence

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The FDA has announced new goals to help modernize its procedures and respond to new technologies. In a blog post by FDA Commissioner Scott Gottlieb, M.D., the agency expressed new priorities to help modernize clinical trials...more

Knobbe Martens

FDA Announces Innovation Challenge for Devices to Prevent and Treat Opioid Use Disorder

Knobbe Martens on

The Food and Drug Administration (FDA) has announced a medical device innovation challenge to help address opioid abuse and misuse. With the FDA Innovation Challenge: Devices to Prevent and Treat Opioid Use Disorder, the FDA...more

Skadden, Arps, Slate, Meagher & Flom LLP

FDA Strives to Adapt Regulatory Approach to Rapidly Evolving Digital Health Space

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Just two months after taking office, in July 2017, Food and Drug Administration (FDA) Commissioner Scott Gottlieb announced the agency’s Digital Health Innovation Action Plan, which recognized that “digital technology has...more

Knobbe Martens

FDA Announces Plans for Alternative Clearance Pathway

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The U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb recently announced that the agency plans to publish a draft guidance outlining a voluntary alternative pathway for new, moderate-risk devices for use in...more

Knobbe Martens

FDA Provides Guidance on 3D-Printed Medical Device Products

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The U.S. Food and Drug Administration released finalized guidance regarding 3D printing in medical devices. The guidance document, which issued on December 5, 2017, is based on the FDA’s review of more than 100 devices...more

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