FDA Final Guidance On BPH Device Studies Suggests Swift Patient Follow-Up
A new guidance document from the US agency strongly urges makers of medical devices for treating benign prostatic hyperplasia (BPH) – a common form of age-related prostate enlargement – to quickly conduct post-treatment evaluations as part of investigational studies.
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In this FINAL EPISODE of Speaking Of Medtech: The US FDA got something it desperately wanted in its latest user-fee package with industry: a Total Product Lifecycle Advisory Program pilot, or TAP. The agency says TAP will allow for earlier and more frequent engagement with developers – but is it needed?
People with obesity now have new tools to help them lose weight, thanks to the US agency’s de novo authorization.