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If your medical device requires FDA 510k clearance but you put it on the market without a 510k, what happens?Many clients have asked us: do we have a medical device? Do we need to submit a 510k? [...]

If you've designed a home health kit to test for, say, pregnancy or HIV, can you go ahead and market the product without FDA clearance or state law authorization? FDA regulates some health test [...]

Because marketing and distributing dietary supplements carries FDA risk, we offer sample strategies to reduce FDA risk when selling dietary supplements.

Health care governing boards can look to "Practical Guidance for Health Care Governing Boards on Compliance Oversight" for advice in designing a compliance program.

Arkansas has a enacted statute encouraging telemedicine use. In Arkansas, SB 133, designed to "encourage the use of telemedicine," advises all state agencies to evaluate and amend their policies [...]

Michael H Cohen will be presenting Legal Issues In Integrative Healthcare for The Leadership Program in Integrative Healthcare at Duke University.