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Sponsors submitting a 510(k) application for certain soft contact lenses may demonstrate substantial equivalence to previous lenses instead of having to conduct a direct comparison to a prior device, the FDA said in a final guidance released yesterday.
In a pair of final guidances released Friday, the FDA laid out what it intends to do with multiple pandemic-era device policies and Emergency Use Authorizations (EUAs) when the public health emergency formally ends on May 11. Read More
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has proposed major reforms to its clinical trial regulations — including a 30-day maximum for reviewing new trial applications and a 10-day maximum for granting a decision after receiving requested follow-up information. Read More
The FDA is standing up a new program to provide a framework for regulators, researchers and the public to explore how digital health technologies (DHT) — such as mobile medical apps and wearable devices — can advance drug development. Read More
The European Medicines Agency (EMA) reported “remarkable” progress, despite the pandemic, in a mid-point assessment of its “Regulatory Science Strategy to 2025” to build a more adaptive regulatory system that will encourage innovation — including advances in clinical trial innovation and a new real-world data (RWD) network. Read More
Funding in the fiscal 2024 budget to make sure the U.S. is prepared for potential medical device shortages is one of the top concerns for the FDA’s Center for Devices and Radiological Health (CDRH), according to CDRH Director Jeff Shuren. Read More
The FDA, the American Society of Plastic Surgeons and the Plastic Surgery Foundation have added squamous cell carcinoma (SCC) in the capsule around breast implants to the PROFILE registry where healthcare providers can submit case reports of SCC and other breast cancers associated with breast implants.
The FDA has updated its device shortage list to reflect changes in the estimated shortage durations for six categories of medical devices, continuing its monitoring of the supply chain in light of the high demand and shortages resulting from the COVID-19 public health emergency.
The FDA’s Center for Diagnostic and Radiological Health (CDRH) has released a schedule of upcoming enhancements to its Electronic Medical Device Reporting (eMDR) system to provide early notice to manufacturers.