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Category: Regulatory Affairs

September 510K Clearance Highlights

Accel Groups select ten medical devices or in vitro diagnostic reagents from the monthly 510(k) clearance list (five from Chinese manufacturers and five from foreign manufacturers) for brief introductions.

August FDA Clearance Highlights

Accel Groups select ten medical devices or in vitro diagnostic reagents from the monthly 510(k) clearance list (five from Chinese manufacturers and five from foreign manufacturers) for brief introductions. This aims to provide the latest global updates on medium and low-risk devices or reagents.

FDA Releases Highly Anticipated Draft Guidance on Device Registration Changes

FDA issued a draft guidance on August 22 detailing the types of modifications it considers suitable for inclusion in a Predetermined Change Control Plan (PCCP) and the information sponsors should include in their premarket approval (PMA), de novo, or 510(k) submissions to support their proposed PCCP.

FDA Issues Dental Curing Lights Guidance, Soliciting Feedback

FDA published the draft guidance "Dental Curing Lights - Premarket Notification (510(k)) Submissions - Draft Guidance for Industry and Food and Drug Administration Staff," on July 12, 2024, for feedback. Feedback needs to be submitted by September 10, 2024.

FDA Expands Total Product Life Cycle Advisory Program, Bringing Benefits for Cardiovascular, Neurological, Radiological, Ophthalmic, and Orthopedic Devices

In October 2022, the FDA launched the "Total Product Life Cycle Advisory Program (TAP)" pilot to accelerate the development of innovative medical devices and technologies critical to public health. TAP facilitates "early, frequent, and strategic communication" with the FDA to enhance collaboration with manufacturers and third parties, speeding up patient access to innovative medical devices.

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.

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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