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Akin Gump Strauss Hauer & Feld LLP

FDA Proposes Additional Flexibility for Mobile Health Products

Akin Gump Strauss Hauer & Feld LLP on

Draft Guidances Address General Wellness Products and Device Accessories - The U.S. Food and Drug Administration (FDA or “the Agency”) has announced two more key parameters of its regulatory approach to mobile health...more

Mintz - Health Care Viewpoints

FDA Proposes to Apply Risk-Based Framework to Accessory Devices

Mintz - Health Care Viewpoints on

In another effort to bring some clarity to its regulation of devices, the FDA has released draft guidance on how its risk-based framework applies to accessory devices ( the “Draft Guidance”). This development is welcome...more

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