Warning Letter Close-Outs – November 2017
US FDA released seven device-related close-out letters in November.
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The revised guidance document clarifies the Q-submission meeting process, alternate ways sponsors may obtain FDA feedback, and more.
MDSAP Audit Allows Emerging Firm To Expand Internationally
Blood-collection technology firm Tasso has been recommended for certification by MDSAP. The international qualification is part of a push to offer the company’s technology in countries such as Australia and Canada, CEO Ben Casavant told Medtech Insight.
FDA’s Power Morcellation Containment System Guidance Doc Finalized
The US FDA has finalized a guidance document that details performance assessment standards for power morcellation containment systems. The class II devices have been an object of special scrutiny since the agency learned that power morcellation could spread cancerous tissue throughout the body.