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Animal studies meant to support a medical device premarket approval application should be conducted using the device in its finished form, according to a final guidance the FDA issued yesterday.
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.
The expanded approval is for patients who are at least 13 years old who cannot be effectively treated with continuous positive airway pressure (CPAP) therapy. Read More
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