SQA

JULY 8, 2022

V60 and V60 Plus devices are designed for in-hospital use. Philips has no permanent solution to correct this issue, so the MHRA is issuing this alert to help hospitals manage the risk. It is not intended to provide information on the terms and procedures directly associated with regulatory requirements governing cell-based products.

Pharmaceutical Industry 40

Pharmaceutical Industry FDA Hospitals World Health 40

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. 1] E.g., Anna Edney, Kids’ Covid Hospitalizations Hit Record in U.S. Bureau 1, 2 (2014); Robert B. Omicron Surge , Bloomberg (Dec. & Fams.,

COVID-19 Vaccine 130

COVID-19 Vaccine COVID-19 Informed Consent Governance 130

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.

FDA 98

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. The following two PIC/S guidance documents have been revised: PE 005-4: PIC/S Good Practice Guidelines for Blood Establishments and Hospital Blood Banks. b) and 320.31(d)(3)).

FDA 83

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. This standard is a globally recognized standard that provides guidelines for the governance and management of AI technologies.

FDA 52

FDA Compliance COVID-19 Public Health 52

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”).

FDA 59

FDA Governance Nurses Hospitals 59

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.

Compliance 52

Compliance FDA Governance State Policy 52