RAPS

Custom Medical Device Definition Clarified in Final FDA Guidance

The US Food and Drug Administration (FDA) has issued a new final guidance document intended to clarify the process by which manufacturers of "custom" medical devices can comply with federal ...
RAPS

FDA clarifies definition of devices vs. counterfeit devices

The US Food and Drug Administration has published draft guidance updating its definition of a device in accordance with the 2021 Safeguarding Therapeutics Act. The document – published 10 November – ...
JD Supra

Drawing the Device Line: FDA Seeks Public Input on Patient Safety and Non-Device Health Software

On July 14, the U.S. Food and Drug Administration (FDA) announced it is seeking public input regarding the patient safety impacts of certain medical software functions excluded from the definition of ...
iLounge

The Complete Guide to High-Definition Streaming Applications Across Apple Devices in Canada

Streaming has become a normal part of entertainment for Canadian households. Instead of relying on a single television source, viewers can now use connected devices to access live television, movies, ...
MD&M East

FDA Clarifies When Software & Wellness Products Are Not Medical Devices

Medical device manufacturers developing digital health products face a recurring question: Will the U.S. Food and Drug Administration (FDA) regulate this product? Many digital health products can ...