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Five Findings from the FDA’s List of AI Medical Devices

An increasing number of medical devices are incorporating artificial intelligence or machine learning (AI/ML) functionalities. The FDA updated its list of AI/ML-enabled devices on May 13, 2024, adding 191 newly approved devices, bringing the total to 882.

FDA Releases Long-awaited Device Remanufacturing Guidance

The FDA published final guidance on the remanufacturing of medical devices on May 9, 2024. It adds a new section on regulatory requirements that clarifies remanufacturers are subject to investigations and inspections by the agency.

UK Proposes Recognition of Medical Devices Approved by Australia, Canada, EU, and US! To be Effective in 2025

On May 21, the UK's Medicines and Healthcare products Regulatory Agency (MHRA) proposed allowing medical devices to enter the UK market, provided they are authorized in "comparable regulatory countries" (CRC), starting with the regulatory bodies of Australia, Canada, the EU, and the US, with Japan to be considered next. This draft is expected to take effect in 2025.

FDA Proposes Updates to Device Cybersecurity Guidance

The FDA released a draft guidance on March 13, 2024, aiming to update its existing guidance on the cybersecurity of medical devices. Public comments are open until May 13, 2024, following which the FDA will review and incorporate feedback into the final guidance document.

Former FDA Reviewers: How to Avoid Missteps in STeP, Breakthrough Device Submission

Medical device experts discussed at the 2024 RAPS Global Regulatory Strategy Conference how to submit materials for the FDA's Breakthrough Devices program and the Safety Technology Plan (STeP), as well as how to respond to deficiency letters.

Safer Technologies Program (SteP) for Medical Devices

In 2021, the FDA established the "Safer Technologies Program" (STeP) to cover medical devices that do not qualify for the Breakthrough Devices Program.

SaMD Cleared for AI Pre-Screen for Low Bone Mineral Density

Warning Letters Issued to Three Plastic Syringes Companies in China

In November 2023, the FDA informed public the potential for device failures (such as leaks, breakage, and other problems) with plastic syringes manufactured in China, that are used for injecting fluids into, or withdrawing fluids from, the body.

FDA Clears First OTC Continuous Glucose Monitor

The FDA cleared the first over-the-counter (OTC) continuous glucose monitoring system (CGM) on March 5, 2024.

95 Breakthrough Devices Approved So far to Hit U.S Market

FDA updated the Breakthrough Devices Program webpage to update the device designations data and the marketing authorizations list on March 21, 2024.

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