Health Law Advisor

AUGUST 10, 2023

But the question is, to what extent do health care providers need to worry about FDA requirements as they use AI? FDA has been regulating machine learning algorithms used in a clinical context for decades. It’s important to understand that FDA regulation isn’t punitive in the sense that it’s only intended to apply to bad people.

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SQA

AUGUST 2, 2021

ISO 18082:2014, Anesthetic and respiratory equipment – Dimensions of non-interchangeable screw-threaded (NIST) low pressure connectors for medical gases. Led by the FDA and ASPR, the White House report and its recommendations ( report PDF ) have been accepted by President Biden. United States FDA – Guidances for Devices.

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SQA

JULY 8, 2022

It is not intended to provide information on the terms and procedures directly associated with regulatory requirements governing cell-based products. 536/2014 on Clinical Trials, which will replace EU Annex 13. 536/2014 on Clinical Trials replacing EU Annex 13. PIC/S Annex 13 has been revised based on EC Regulation No.

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Bill of Health

AUGUST 29, 2022

Some children may be unvaccinated by no choice of their own, but instead because of decisions made by parents, guardians, or state or local government officials. Bureau 1, 2 (2014); Robert B. In this post, I argue that young people should have the opportunity to consent to vaccines. Omicron Surge , Bloomberg (Dec. & Fams.,

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Health Law Advisor

MAY 20, 2022

Since the passage of the Medical Device Amendments of 1976, FDA has regulated in vitro diagnostic (IVD) tests as medical devices, subject to a full suite of FDA requirements. FDA’s approach changed in 2014 when it issued draft guidance describing a plan to phase out FDA enforcement discretion and regulate LDTs.

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SQA

FEBRUARY 26, 2024

The glossary was originally published in 2014 and has been used to define excipient terms and acronyms commonly found in IPEC guides. This standard is a globally recognized standard that provides guidelines for the governance and management of AI technologies.

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Bill of Health

MAY 28, 2024

Since 2014, Congress has passed spending amendments that limit the use of federal funds for enforcement against state-compliant medical marijuana programs. Notably, the recommendation was the first statement from a federal government agency that marijuana has a currently accepted medical use and a low potential for abuse.

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Kaiser Health News

JUNE 2, 2022

when the FDA approved mifepristone in 2000. Some legal and drug regulatory experts argue that because the FDA is the federal agency responsible for protecting public health by ensuring the safety, efficacy, and security of human drugs, states wouldn’t have the power to overrule its stamp of approval and outlaw the abortion pill.

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Drug & Device Law

OCTOBER 23, 2023

312 (2008), that essentially all product liability claims against manufacturers of FDA pre-market approved (“PMA”) medical devices were preempted. 273, 288 (2014); PLIVA, Inc. at 349 (“The FDCA leaves no doubt that it is the Federal Government rather than private litigants who are authorized to file suit for noncompliance”).

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Drug & Device Law

MAY 26, 2023

We are not looking do either of those, but we will weigh in on what NPP means for non-product liability cases involving FDA-regulated medical products. Both talk a fair amount about “commerce” and the respective roles of the states and federal government. Are we down to talk about NPP and its impact on reproductive rights litigation?

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Drug & Device Law

MARCH 3, 2022

have dockets heavy on administrative cases and other cases involving the functioning of the federal government and light on product liability cases. Indian Ocean, on March 8, 2014 , 352 F. With more than eight years on the federal bench, that is not many decisions. Part of that may be that the D.D.C. Even the D.C. 3d 129 (D.D.C.

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Drug & Device Law

NOVEMBER 10, 2023

These class certifications combined 428 different pharmaceutical products, produced and marketed by 28 separate defendants, with claims governed by the laws of 52 separate jurisdictions. FDA, “ Statement on the agency’s ongoing efforts to resolve safety issue with ARB medications ” (Aug. Valsartan , 2023 WL 1818922, at *24.

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Drug & Device Law

JANUARY 15, 2024

That is significant because, unlike (now) every other state in the country, since 1987 Pennsylvania precedent prohibited defendants from introducing evidence of their compliance with government and/or industry standards (“standards compliance” or “compliance” evidence, for short) in strict liability design defect cases – generally.

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Drug & Device Law

FEBRUARY 29, 2024

Not to mention, it is a powerful defense for our clients in product liability matters because it can foreclose liability and plaintiffs’ use of tort lawsuits (invariably creatures of state law origin) to impose requirements on medical devices or pharmaceuticals that the federal FDA did not. What could be better than preemption? United Bhd.

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Drug & Device Law

MARCH 29, 2022

2228 (2014), and since we do not want to suggest that POM Wonderful had any effect on preemption, we restate the distinction here. While case specific holdings on the issue vary, the general principle is that if a Lanham Act claim challenges an FDA policy choice, meaning the court has to interpret or enforce FDA regulations, it is barred.

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Drug & Device Law

FEBRUARY 24, 2022

341 (2001), stands for the proposition that only the federal government may enforce the Food, Drug, and Cosmetic Act and that any state-law claim that depends on the existence of the FDCA is impliedly preempted by 21 U.S.C. § 2014); Caplinger v. Plaintiffs’ Legal Committee , 531 U.S. Medtronic, Inc. , 3d 1026, 1034 n.22 Riley , 625 F.

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Drug & Device Law

MARCH 19, 2024

Plaintiff had surgery in 2014 in which the clips were used. Plaintiff’s primary allegation is that the clips have a migration rate higher than what was reported to the FDA. Since the clips are PMA, the first prong is met—PMA devices have specific FDA requirements. In 2021, a CT scan revealed the clips had migrated.

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Drug & Device Law

MARCH 13, 2023

That attempt disregards seven Pennsylvania Supreme Court decisions between 1948 ( Henderson ) and 2014 ( Lance ), as well as the Pennsylvania Superior Court (an intermediate appellate court in Pennsylvania) ( Creazzo ), all rejecting application of strict liability principles to prescription medical products. E.g. , Lewis v. 3d 357 (3d Cir.

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Drug & Device Law

FEBRUARY 20, 2023

But in prescription medical product liability litigation, products must receive FDA approval, clearance or other authorization (hereafter, collectively referred to as “approval” for short) before they can be marketed. Are manufacturers liable only for failing to employ an alternative design that the FDA has approved for distribution. . .

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