4. “It's a medical-grade magnifying glass” – enforcement discretion or unregulated. Even though it hints at medical use, I believe FDA would decide that it is very low risk and not worthy of FDA ...

Here’s what food and drug regulation might look like under the Trump administration Leaders of the FDA have published a list of new priorities for the agency.

The Boston wearables firm says the software tool doesn't meet the definition of a medical device and shouldn't be regulated ...

When U.S. regulators aren’t in the room while global standards are written, the future of patient safety, medical innovation, ...