News
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.
The FDA released a draft guidance on March 13, 2024, aiming to update its existing guidance on the cybersecurity of medical devices.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.
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.
In 2021, the FDA established the "Safer Technologies Program" (STeP) to cover medical devices that do not qualify for the Breakthrough Devices Program.
