On July 28, the U.S. Food and Drug Administration (FDA) issued the final guidance “Multiple Function Device Products: Policy and Considerations,” which describes FDA's regulatory approach and policy for products with multiple...more
On 6 September 2019 the U.S. Food and Drug Administration (FDA or the agency) issued its final guidance document entitled "Humanitarian Device Exemption (HDE) Program."
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On Tuesday, FDA announced the availability of a draft guidance, “Principles of Premarket Pathways for Combination Products,” with high-level information on ways to bring combination products to market....more
On May 15, 2018, the Food and Drug Administration (FDA) proposed amending its product classification rules for combination products, found in 21 CFR Part 3. Generally, the proposed rule purports to clarify language in the...more
5/31/2018
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