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Community Integration: Pushing the Boundaries for a Better World

Integrated Care News by CFHA

An integrated care champion could be selected to represent the clinic in meetings with community agencies, and community representatives should be included on the Clinic Advisory Boards. Collaboration with a legal aid organization could include establishing an on-site legal clinic when feasible.

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FDA’s New Draft Guidance on 510(k) Implant Devices: What You Need to Know

FDA Law

airport security screening), or surgical procedures, as well as the potential for reoperation or revision of the implant. Non-Clinical Recommendations The draft guidance highlights non-clinical review areas that are generally relevant across 510(k) Implants and offers recommendations for performance data to include in a 510(k) submission.