Industry insiders can all agree that the U.S. Food & Drug Administration (FDA) regulates the use of medical devices. Most insiders agree that a medical device is any instrument, apparatus, implement, ...

8. Guidance document: Off-The-Shelf Software Use in Medical Devices FDA itself has said that section 3.2.2 of this guidance is out-of-date because it characterizes laboratory information management ...

Many of President Trump’s executive orders (EOs) and legislative measures have been designed to curtail federal regulation, reduce the size of the administrative state, and withdraw the U.S. from ...

There, he counsels medical device, drug, and combination product companies on a wide range of FDA regulatory, reimbursement, and clinical trial issues. Since the Medical Device Amendments of 1976, a ...

Research and Markets has announced the addition of the "FDA's Medical Device Software Regulation Strategy: 2-Day In-Person Seminar by Ex-FDA Official" conference to their offering. This seminar will ...

Opinion: Companies developing AI-enabled health-care technologies should treat regulatory and IP strategies as parallel, ...

DUBLIN--(BUSINESS WIRE)--The "Medical Device Software: Complying with the EU MDR, EU IVDR & FDA Regulations" conference has been added to ResearchAndMarkets.com's offering. This intensive four-day ...

Expertise from Forbes Councils members, operated under license. Opinions expressed are those of the author. In 2023, the Food and Drug Administration (FDA) took a more active approach to medical ...

When the Federal Drug Administration (FDA) updated the provisions for medical device cybersecurity, one of those required the development of a software bill of materials (SBOM). It’s now mandatory for ...

The rise of AI in health care presents new challenges related to the patentability and regulation of AI-driven medical technologies. This article examines the 2024 guidelines from the U.S. Patent and ...