FDA issues guidance on designing pivotal medical-device trials

11/22/2013 | Clinica (subscription required)

New guidance outlining the principles that sponsors should follow when crafting pivotal clinical trials to back premarket-approval applications for medical devices has been issued by the FDA. The document also can serve as a guide for sponsors carrying out clinical trials to back medical-device applications under the 510(k) clearance and de novo programs, the agency said.

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