If your medical device requires FDA 510k clearance but you put it on the market without a 510k, what happens?
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If your medical device requires FDA 510k clearance but you put it on the market without a 510k, what happens?

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? [...]

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How are home health kits regulated under FDA and state law?
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In FDA & FTC Law, Healthcare Law
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How are home health kits regulated under FDA and state law?

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 [...]

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Dietary Supplements – Strategies to Reduce FDA Risk
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In Dietary Supplements (Claims and Labeling), FDA & FTC Law
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Dietary Supplements – Strategies to Reduce FDA Risk

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

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What healthcare compliance program policies and procedures should be included in healthcare compliance program?
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In Healthcare Law
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What healthcare compliance program policies and procedures should be included in healthcare compliance program?

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

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