News & Analysis as of

Intended Use

Epstein Becker & Green

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

When I was working on my Masters in data science, one of the projects I did was to create an algorithm that would take an intended use statement for a medical device and predict whether FDA would require a clinical trial.  It...more

Fox Rothschild LLP

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

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On September 1, 2021, the Food and Drug Administration’s final “intended use” rule will go into effect. The update is meant to clarify the “intended use” regulations for pharmaceutical products and medical devices...more

Skadden, Arps, Slate, Meagher & Flom LLP

FDA’s Final Rule on Intended Use: ‘Getting Right Back to Where We Started From’

On August 2, 2021, the U.S. Food and Drug Administration (FDA) issued its final rule amending the intended use regulations codified at 21 CFR 801.4 and 21 CFR 201.128, marking the end of an effort FDA began in 2015. While the...more

Arnall Golden Gregory LLP

If FDA Can Read Your Mind ... What a Tale Your Product Might Tell: FDA Amends Its "Intended Use" Regulations

In 1970, Gordon Lightfoot released the classic song “If You Could Read My Mind,” where he sings, “If you could read my mind, love, what a tale your thoughts could tell.” Fifty-one years later, the Food and Drug Administration...more

Faegre Drinker Biddle & Reath LLP

FDA issues final rule clarifying its “intended use” regulations for pharmaceuticals and medical devices

The FDA issued a final rule (RIN 0910-A147) on August 2, 2021, to clarify its “intended use” regulations for pharmaceutical products and medical devices — 21 CFR §201.128 (drugs) and 21 CFR §801.4 (devices). The final rule...more

Stinson LLP

FDA Finally Finalizes the Intended Use Rule

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Last week, FDA published its new final rule amending the “intended use” regulations for drugs and medical devices, which it hopes will “put to rest any dispute” about the agency’s interpretation of evidence relevant to...more

King & Spalding

FDA Finalizes “Intended Use” Regulations

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On August 2, 2021, the U.S. Food & Drug Administration (“FDA” or “the Agency”) published a final rule amending its medical product “intended use” regulations in an effort to provide direction and clarity to regulated industry...more

Foley Hoag LLP

New Intended Use Rule Finalized

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On August 2, 2021, the Food and Drug Administration (FDA) published its final intended use rule (the “Final Rule”). The Final Rule amends FDA’s regulations describing the types of evidence relevant to determining a product’s...more

Hogan Lovells

After a long and winding road, FDA finalizes much-debated “intended use” rule

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On August 2, 2021, the U.S. Food and Drug Administration (FDA) published a final rule to amend its “intended use” regulations, codified at 21 CFR § 801.4 for medical devices and 21 CFR § 201.128 for drugs. This updated final...more

MoFo Life Sciences

Software As A Medical Device In Europe – New Regulatory Regime About To Enter Into Force – (Part 2 Of 6)

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In Part 2 of our series of consecutive articles on the reformed regulatory framework under the EU Medical Device Regulation 2017/745 (“MDR”), which will soon govern medical devices software (“MDSW”) in the EU, we will shed...more

Wilson Sonsini Goodrich & Rosati

FDA Issues Proposed Rule Clarifying the Types of Evidence It Considers When Determining the Intended Use of a Product

Recently, the U.S. Food and Drug Administration (FDA) issued a statement and proposed rule clarifying the types of evidence that the FDA considers when determining the "intended use" of a product. Intended use is important...more

Mintz - Health Care Viewpoints

FDA’s Prescription Drug Advertising Enforcers Issue COVID-19-Related Warning Letter

The U.S. Food and Drug Administration (FDA) recently announced what appears to be the first public warning made by the agency to a company promoting an approved prescription drug product for the unapproved use of treating...more

Sheppard Mullin Richter & Hampton LLP

FDA’s Proposed Rule on “Intended Use” Confirms Agency Will Rely on “Any Relevant Source” of Evidence

On September 23, the U.S. Food and Drug Administration (FDA) published a proposed rule to modify its intended use regulations. In its current form, the regulations have created long-standing confusion as to whether mere...more

Troutman Pepper

FDA Proposes Modified “Intended Use” Regulations

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In its latest effort to provide direction and clarity to regulated industry and stakeholders, on September 23, the U.S. Food and Drug Administration (FDA) published a proposed rule and preamble amending its medical product...more

Arnall Golden Gregory LLP

FDA Issues Proposed Rule Seeking to Clarify Evidence Relevant to Its Intended Use Determinations of FDA-Regulated Products

On September 23, 2020, the U.S. Food and Drug Administration (FDA) published in the Federal Register a proposed rule titled, “Regulations Regarding ‘Intended Uses.’”...more

Hogan Lovells

COVID-19 Report for Life Sciences and Health Care Companies (UPDATED)

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The COVID-19 Report is a compilation of coronavirus news, analysis, and insights from around the world to help life sciences and health care companies stay current in this challenging time. ...more

ArentFox Schiff

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

ArentFox Schiff on

Last week FDA published a proposed rule that would revise the agency’s “intended use” regulations to clarify that a manufacturer’s knowledge of off-label use of its drug or device is, by itself, not sufficient to establish a...more

McDermott Will & Emery

FDA Issues Intended Use Proposed Rule, Repealing and Replacing January 2017 Final Rule

McDermott Will & Emery on

On September 23, 2020, the US Food and Drug Administration (FDA) published its Regulations Regarding “Intended Uses” proposed rule (Proposed Rule) to amend its “intended use” regulations at 21 C.F.R. §§ 201.128 and 801.4. The...more

Hogan Lovells

FDA proposes clarification in long-running tussle over “intended use” rules for drugs and devices

Hogan Lovells on

On September 23, the U.S. Food and Drug Administration (FDA) published a proposed rule to modify its intended use regulations to clarify the types of evidence FDA will consider when determining the “intended use” of a medical...more

Stinson LLP

FDA Proposes (Again) to Amend the "Intended Use" Regulation

Stinson LLP on

This week, FDA published a proposed rule that would amend its medical product "intended use" regulations, 21 CFR §§ 201.128 and 801.4 and replace the 2017 Final Rule about the same issue that never became effective....more

King & Spalding

FDA Proposes New Rule Modifying its “Intended Use” Regulations

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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.” If finalized, the rule would amend...more

McDermott Will & Emery

Intended Use Preamble Not Limiting; Diligence Must Only Be Reasonably Continuous

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In an opinion addressing claim construction and priority dates, the US Court of Appeals for the Federal Circuit explained that preamble language is not limiting when it merely recites an intended use, and that diligence need...more

Fox Rothschild LLP

The Ex Post Facto Effect: The U.S. Supreme Court’s DeVries Decision And Asbestos Litigation In The United States

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Colleagues and clients frequently pose the question whether after more than forty years the asbestos litigation juggernaut has finally neared its inevitable conclusion. The United States Supreme Court’s recent decision in...more

Blank Rome LLP

The Supreme Court Adopts a Middle of the Road Approach When Deciding a Manufacturer’s Duty to Warn in the Context of Maritime Tort...

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On March 19, 2019, the U.S. Supreme Court in Air & Liquid Systems Corp. v. Devries held that, under maritime law, a product manufacturer has a duty to warn of asbestos or other hazardous parts when its own product, although...more

Beveridge & Diamond PC

Too Much to “Bare”: US Supreme Court Rejects Bare Metal Defense Under Federal Maritime Law

In an eagerly anticipated decision by the asbestos bar, the United States Supreme Court in Air & Liquid Systems et al. v. DeVries et at., Dkt. No. 17-1104, 2019 WL 1245520 (March 19, 2019) rejected the “bare metal defense” as...more

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