WebThe FDA issued a final rule (RIN 0910-A147) on August 2, 2024, to clarify its “intended use” regulations for pharmaceutical products and medical devices — 21 CFR §201.128 (drugs) and 21 CFR ... (Comment 28) In the NPRM, FDA proposed to amend §§ 201.128 and 801.4 to provide that a firm would not be regarded as intending an unapproved new use for an approved drug or for a device approved, cleared, granted marketing authorization, or exempted from premarket notification based … See more We received approximately 15 comment submissions on the proposed rule by the close of the comment period, each containing one or more comments on one or more issues. We describe and respond to the comments in … See more (Comment 10) One comment stated that because the rule identifies speech as potentially relevant to establishing intended use, and such speech may be truthful, the rule is … See more (Comment 1) One comment asserted that under the relevant statutes, legislative history, and case law, evidence of intended use is limited to promotional claims that have … See more (Comment 7) Several comments stated that FDA should reconsider the proposed regulatory text identifying evidence about the “design or composition” of an article as a type of evidence relevant to establishing intended use. Some … See more
EPA proposes limits on carcinogenic gas used to sterilize medical …
WebSep 23, 2024 · FDA proposes to amend its intended use regulations for medical products (§§ 201.128 and 801.4) to better reflect the Agency's current practices in evaluating … WebAug 12, 2024 · FDA published a proposed rule in 2015 to amend the regulatory definitions of intended use “to reflect how the Agency currently applies them to drugs and devices.” … brandon zavala
Compliance takeaways from FDA’s final ‘intended use’ rule
WebAug 26, 2024 · On August 2, 2024, the U.S. Food and Drug Administration (“FDA”) published a final rule amending existing regulations (21 C.F.R. § 201.128 and 21 CFR § 801.4) that describe the types of evidence relevant to determine a drug or device’s intended use under the Food, Drug and Cosmetic Act (“FDCA”).See 86 Fed. Reg. … WebThis guidance 1 document identifies the general principles that will be considered by the Food and Drug Administration (FDA) in determining when a specific indication for use is … WebAug 6, 2024 · On August 2, 2024, the Food and Drug Administration (FDA) published its final intended use rule (the "Final Rule"). 1 The Final Rule amends FDA's regulations … brandon zackey