Clinical Data from OUS Studies Get Guidance From FDA
Today the FDA released a draft guidance that could give manufacturers more direction on how they can use clinical data from studies conducted outside of the United States to support device submissions.
It is worth noting that this is not a new FDA policy. The agency is simply proving more insight on the issue.
Once final, the guidance will offer the following:
- FDA’s policy of accepting scientifically valid clinical data from foreign clinical studies in support of premarket submissions for medical devices
- The special considerations that apply when using OUS data, including applicability of the data to intended patient populations within the United States and study design issues,
- Recommendations to assist sponsors in developing data that meet FDA standards to support approval of clearance of the device in the U.S.
The comment period for the draft, Acceptance of Medical Device Clinical Data from Studies Conducted Outside the United States (OUS), is open for the next 90 days.
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Maria Fontanazza
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Maria Fontanazza has more than 15 years of experience in journalism, marketing and communications. She was previously marketing communications manager and market research manager at Secant Medical, Inc., a manufacturer of biomedical textiles and advanced biomaterials. Fontanazza also served as an editor at MD+DI and has authored articles that have appeared in domestic and international industry publications. Fontanazza has a B.A. in Journalism and Mass Communications with a concentration in New Media and Visual Design, and a Minor in Fine Arts, from St. Michael’s College in Colchester, VT. Follow her industry insights on Twitter at @MariaFontanazza. Contact Maria