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

Hall Render

AUGUST 31, 2023

Food & Drug Administration (“FDA”) approval and regulation of mifepristone (brand name Mifeprex), a drug used in medically induced abortions. The panel vacated in part and affirmed in part a decision by a District Court judge in Texas that would have suspended the FDA’s approval of mifepristone. Jackson Women’s Health.

FDA 40

FDA COVID-19 40

Dot Compliance

JUNE 16, 2022

The two most relevant quality regulations for medical device manufacturers are the FDA 21 CFR Part 820 and the ISO 13485:2016. The QMS supports the manufacturers, leading to ISO confirmation and FDA compliance. The FDA 21 CFR Part 820 is the mandatory standard for medical devices distributed in the US.

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FDA Regulatory Compliance Compliance Governance 52

SQA

SEPTEMBER 2, 2022

The Regulations were first issued with immediate effect in 2002 and were later revised in 2016. Compared to the 2016 revised version, the draft of the 2022 version includes 101 more articles to conform to the pharmaceutical policy reforms in the recent years and the Drug Administration Law revised in 2019.

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FDA COVID-19 Nursing Homes Compliance 91

Healthcare IT Today

SEPTEMBER 25, 2023

The financing brings total funding to over $100 million since Ibex’s inception in 2016. The solutions are for Research Use Only (RUO) in the United States and are not cleared by the FDA. For more information, including indication for use and regulatory approval in other countries, contact Ibex Medical Analytics.

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FDA Hospitals 69

SQA

AUGUST 2, 2021

These standards include but are not limited to the following list and are available at no charge in read-only format: ISO 374-5:2016, Protective gloves against dangerous chemicals and micro-organisms – Part 5: Terminology and performance requirements for micro-organisms risk. United States FDA – Guidances for Devices. b) and 320.31(d)(3)).

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FDA COVID-19 Pharmaceutical Industry Hospitals 83

Exeed Regulatory Compliance

APRIL 6, 2020

Recently, the FDA has authorized the emergency use of the Battelle CCDS Critical Care Decontamination System , which uses vapor phase hydrogen peroxide to decontaminate N95 or N95-equivalent respirators for reuse by healthcare personnel. This is one of the criteria used by the FDA for granting the Emergency Use Authorization.

COVID-19 52

COVID-19 FDA Public Health 52