- FDA Clarifies Types of Evidence Relevant to Determining the ...🔍
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- FDA Seeks to Clarify Evidence for Intended Use Determinations🔍
- FDA issues final rule clarifying its “intended use” regulations for ...🔍
- FDA's Final Rule on Intended Use🔍
- Regulations Regarding “Intended Uses”🔍
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- Intended Uses 🔍
FDA Seeks to Clarify Evidence for Intended Use Determinations
FDA Clarifies Types of Evidence Relevant to Determining the ...
The proposed revisions to the intended use regulations do not reflect a change in the FDA's policies and practices, but rather seek to clarify ...
FDA Issues Proposed Rule Seeking to Clarify Evidence Relevant to ...
FDA Issues Proposed Rule Seeking to Clarify Evidence Relevant to Its Intended Use Determinations of FDA-Regulated Products ... Footnotes for this ...
FDA Seeks to Clarify Evidence for Intended Use Determinations
A new proposed rule FDA will help to provide better clarity on the types of evidence used to determine intended use of products regulated by ...
FDA Clarifies Types of Evidence Relevant to Determining the ...
The FDA is proposing updates to its regulations in order to clarify the types of evidence that it considers when determining the "intended use" of a product ...
FDA issues final rule clarifying its “intended use” regulations for ...
Second, the FDA provides clarification that “intended use” is determined by looking to “any relevant source” of evidence, including direct and ...
FDA's Final Rule on Intended Use: 'Getting Right Back to Where We ...
On August 2, 2021, the US Food and Drug Administration (FDA) issued its final rule amending the intended use regulations codified at 21 CFR 801.4 and 21 CFR ...
Regulations Regarding “Intended Uses” - Federal Register
The Food and Drug Administration (FDA, the Agency, or we) is proposing to amend its medical product "intended use" regulations.
Proposed Rule Outlines Evidence Relevant to FDA's Determination ...
§201.128 — follows a series of regulatory initiatives through which the FDA has sought to have the regulations reflect its current policies on intended uses, ...
Regulations Regarding “Intended Uses” - Federal Register
The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to amend its medical product "intended use" regulations.
However, because this rule would merely clarify, but not change, the types of evidence relevant to determining manufacturers' intended use of products, any ...
FDA seeks to clarify use of real-world evidence to support regulatory ...
“In general, FDA considers the use of RWD to be fit-for-purpose to support generation of clinical evidence for regulatory decision-making for ...
After a long and winding road, FDA finalizes much-debated ...
Any relevant source of evidence may be considered to establish “intended use” ... The recently published final rule aims to address key industry concerns while ...
FDA Guidance Confirms That Multiple Roads Lead to Substantial ...
Substantial evidence, the evidentiary standard for effectiveness established in 1962 by the US Federal Food, Drug, and Cosmetic Act (FD&C ...
General/Specific Intended Use - Guidance for Industry - FDA
Helps manufacturers understand principles used by FDA to determine whether the addition of an indication for use could trigger the need for ...
FDA Proposes Modified “Intended Use” Regulations
Conforming to FDA's longstanding practice, the rule remains very broad, allowing “any relevant source of evidence” to be considered. This ...
1 FDA originally sought to clarify the role of manufacturer ... scope of evidence for this determination to solely statements in ...
FDA clarifies evidence and knowledge requirements in intended use ...
Overall, these changes bring the rules more in line with FDA's current practices for intended use determinations and clarify some off-label and ...
Try, Try Again: FDA Issues Draft Guidance on Communication of ...
Given that FDA asserts broad authority to consider “any relevant source” of evidence when determining intended use and has not clarified when ...
FDA Amends Its "Intended Use" Regulations | News & Insights
The agency clarified that the intended use regulation for medical devices (21 C.F.R. 801.4) applies to devices that are exempt from pre-market ...
FDA Proposes Clarifying Intended Use Regulations
Earlier this year, the United States Food and Drug Administration (FDA) published a proposed rule that would amend its “intended use” regulations for ...