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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FDA Licensing Hospitals Medicaid 98

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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FDA COVID-19 Pharmaceutical Industry Hospitals 83

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. PCPC provided feedback to the FDA on the development of an efficient electronic submission program (Cosmetics Direct) and recognizes that the FDA’s development of Cosmetics Direct is ongoing.

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FDA Compliance COVID-19 Public Health 52

Drug & Device Law

FEBRUARY 25, 2022

We return to a theme we’ve repeated twice before, in 2011 and in 2014 – that in addition to industry-specific groups, manufacturers of prescription medical products should definitely consider joining the Product Liability Advisory Council (“PLAC”). allegations of failure to report adverse events to the FDA. The appeal remains pending.

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FDA 59

Drug & Device Law

MAY 12, 2022

We have posted on these issues many times before, like here and here ; in the prior Enborg post, we predicted that plaintiff’s own FDA expert would inevitably open the door to the sort of FDA evidence that the MDL court had suggested should be excluded in remand cases.). 2:12-CV-4301, 2014 WL 457544, at *5 (S.D.W. at *2-3. (We

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FDA 59

Drug & Device Law

MARCH 2, 2023

In the same month in 2014, the Supreme Court issued the Bauman decision on general personal jurisdiction and the Walden case on specific personal jurisdiction. But BMS and Walden both hold that a plaintiff’s actions cannot qualify as a defendant’s contacts. See here , here , and here , among many posts on the subject.

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FDA Public Health 59

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. Therefore, plaintiff’s claims could not possible “arise out of or relate to” that defendant’s contacts with Rhode Island.

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FDA Fraud Doctors Governance 52