JD Supra

FDA Proposes to Revise “Intended Use” Regulations (Again) to Clarify that Knowledge Alone Is Not Sufficient to Establish Intent

“Intended use” is perhaps one of the most important concepts in FDA law. It is significant in two ways. First, a product’s intended use can dictate whether it is even subject to regulation by FDA, and ...
JD Supra

FDA Proposes New Rule Modifying its “Intended Use” Regulations

Yesterday, FDA published a proposed rule amending its medical product “intended use” regulations in an effort to “provide direction and clarity to regulated industry and other stakeholders.”[i] If ...
RAPS

FDA finalizes long-awaited intended use rule

After multiple delays, the US Food and Drug Administration (FDA) has finalized a rule clarifying its position on the types of evidence it will consider when determining a medical product’s intended ...
The National Law Review

Unpacking Averages: Intended Use Words Most Common to Devices That Require Clinical Trials

We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation and ...
GEN

Adroit Crafting of “Intended Use” Critical

Regulatory Fate of a New IVD May Well Depend on a Few Dozen Words In vitro diagnostic (IVD) devices are comprehensively regulated by the FDA. The FDA, however, does not regulate just the physical ...
RAPS

FDA Delays Implementing Parts of 'Intended Use' Rule

Confusion and concerns over portions of a tobacco-related final rule have pushed the US Food and Drug Administration (FDA) to delay indefinitely the implementation of the sections dealing with the ...
The National Law Review

FDA Proposes Amending the Definition of “Intended Use”

We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation and ...
BioWorld

FDA sustains ‘any relevant source of evidence’ standard in final intended use rule

The FDA has posted a final rule for its intended use policy for devices, drugs and biologics, which formalizes the elimination of the totality-of-the-evidence approach to determining the ...
IPWatchdog

IP Practice Vlogs: Examining When Statements of Intended Use can Limit the Scope of a Patent Claim

Did you know that your claim preamble is more likely to be limiting when you’re dealing with a method claim versus an apparatus claim? In Cochlear Bone Anchored v. Oticon Medical AB, Cochlear’s claim ...