The FDA reverses its stance on a requirement that medical device companies report minor enhancements not related to recalls or adverse events.
The deletion of a single sentence from the FDA's final guidance on distinguishing medical device recalls from product enhancements eliminated a sore bone of contention between the watchdog agency and the medtech industry.
from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/ZtfP5G
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