Regulations Regarding “Intended Uses”

FDA's Regulations on “Intended Use”: One More Try

The words intended uses or words of similar import … refer to the objective intent of the persons legally responsible for the labeling of drugs.

We write on behalf of the Medical Information Working Group (MIWG) with respect to. FDA's proposed rule, “Regulations Regarding 'Intended Uses,' ...

“The Long and Winding Road that Leads”… Back to Where We ...

... regulations at 21 C.F.R. § 201.128 and 21 C.F.R. ... intended uses for marketed products based on incomplete or otherwise flawed data.

Four Ways FDA's New Intended Use Regulations Affect Drug and ...

... regarding the types of evidence relevant to determining a product's intended uses.12 In reality, the final rule purports to transform the ...

The FDA's “Intended Use” Regulations Should Not Restrict Actions ...

See 21 C.F.R. §§ 201.128, 801.4; Regulations Regarding “Intended Uses,” Final Rule, 86 Fed. Reg. 41,383, n.3 (Aug. 2 ...

FDA Seeks to Clarify Evidence for Intended Use Determinations

The proposed rule, “Amendments to Regulations Regarding 'Intended Uses,'” will help to fulfill the FDA's public health mission to provide ...

Final FDA “Intended Use” Rule Goes Into Effect September 1, 2021

According to the FDA, this “should reduce manufacturer and stakeholder uncertainty regarding ... intended uses.” However, the FDA can look to “any ...

FDA Proposes New Rule Modifying its "Intended Use" Regulations

Amendments to Regulations Regarding “Intended Uses,” 82 Fed. Reg. 2,193 (Jan. 9, 2017). 5 2020 Proposed Rule, 85 Fed. Reg. at 59,719-20.

Proposed Rule Outlines Evidence Relevant to FDA's Determination ...

Reg. 2193, Jan. 9, 2017). Under that version of 21 C.F.R. §801.4, the intended uses of devices were to be determined by “the ...

FDA Issues Intended Use Proposed Rule, Repealing and Replacing ...

On September 23, 2020, the US Food and Drug Administration (FDA) published its Regulations Regarding "Intended Uses" Proposed Rule to amend ...

Federal Rules: CLARIFICATION OF WHEN PRODUCTS MADE OR ...

... REGULATIONS REGARDING \"INTENDED USES\"; PARTIAL DELAY OF EFFECTIVE DATE. Bid Protests & Appropriations Law · Bid Protests · Appropriations Law · Federal ...

Clarification of When Products Made or Derived From Tobacco Are ...

Combination Products; Amendments to Regulations. Regarding “Intended Uses”. Docket No. FDA-_____. Regulatory Impact Analysis. Regulatory Flexibility Analysis.

FDA amendments to intended use regulations - CEPK

FDA, Medical Communications, and Intended Use—A New ...

... Regulations Regarding “Intended Uses,” 82 Fed. Reg. 2,193, 2,206 (Jan. 9, 2017) (withdrawn final rule). 313. See Regulations Regarding “Intended Uses,” 85 Fed.

Five Ways FDA's New Final Rule on Intended Use Could Affect ...

Under the amended regulations, the words “intended uses” refer to ... Contacts. If you have any questions regarding this Sidley Update ...

Five Ways FDA's New Final Rule on Intended Use Could ... - Lexology

Under the amended regulations, the words “intended uses” refer to ... News, analysis and research tools covering the regulation and use of data, ...

FDA Clarifies “Intended Use” Regulations - Hogan Lovells

Amendments to Regulations Regarding “Intended Uses” (Final Rule, 82 Fed. Reg. 2193; Proposed Rule, 80 Fed. Reg. 57756). Page 2. 2.

FDA Delays Final Rule on Intended Uses | RAPS

... rule would alter the agency's definition of intended uses for drugs and medical devices. ... related to its interpretation of intended use.

Premarket Notification: A Key Element of US Medical Device ... - NCBI

when it can be determined, based upon valid scientific evidence, that the probable benefits to health from use of the device for its intended uses and ...

Understanding FDA's New Intended Use Rule and its Implications

FDA finalizes long-awaited intended use rule · FDA Delays Implementing Parts of 'Intended Use' Rule · Federal Register's Regulations Regarding “Intended Uses”.