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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Draft guidance from the US FDA updates the agency’s recommendations around research to support new devices for the treatment of prostate enlargement.
On this week’s podcast: From Hawaii to Missouri to Florida, the medtech industry and third-party servicers are duking it out in state legislatures over who has the right to repair and service medical devices.
Manufacturers keen on fostering a culture of quality throughout their organizations should first make sure they have a robust quality strategy in place. Here, BD’s VP of quality management & supplier quality answers a handful of questions on the topic.