SQA

FEBRUARY 22, 2021

Noteworthy changes consist of the down-classification of 15 device types (including optical endoscopes and medical microscopes) and revisions to the entries for 13 product categories (including additional classification adjustments). 26 of 2020 (link in Chinese), relating to the submission of Unique Device Identifier (UDI) information.

COVID-19 52

COVID-19 Compliance Licensing Governance 52

SQA

MAY 24, 2023

MDCG 2023-3 , Questions and Answers on Vigilance Terms and Concepts as Outlined in the Regulation (EU) 2017/745 on Medical Devices, provides additional information on key vigilance terms. The reporting period begins on the day after the awareness date of a serious incident. Although the original awareness date in Section 1.2c

FDA 40

FDA Licensing Governance Compliance 40

Health Law Advisor

AUGUST 10, 2023

In the last couple of years, each Fall, FDA has been updating a list of machine learning applications in health care that the agency has cleared or otherwise approved. [1] FDA has been regulating machine learning algorithms used in a clinical context for decades. 1] As of last Fall, the list included 521 products dating back to 1995.

FDA 98

FDA Licensing Hospitals Medicaid 98

SQA

FEBRUARY 26, 2024

The products had been improperly regularized in ANVISA as cosmetics since they are indicated for injectable use, a form that is not authorized for this category of product. After receiving complaints, ANVSA performed joint inspections with local health surveillance agencies. is a medical device or an accessory to a medical device.

FDA 52

FDA Compliance COVID-19 Public Health 52

Drug & Device Law

JULY 31, 2023

We have blogged several times about the somewhat esoteric issue of whether intangible items – chiefly computer software, website algorithms, and other electronic information – is treated as a “product” for purposes of imposing strict liability on their creators. 19, comment d. 19, comment f. See UCC §§2-103(1)(m), 2-105(1). at 1291-92.

Governance 52

Governance Payment Systems Hospitals Licensing 52

Drug & Device Law

JANUARY 9, 2023

The rulemaking process governing monographs was replaced with an administrative order process. Erroneously, ASH-ADHD chose to rely most heavily on Levine , despite OTC drugs being governed by an entirely different approval scheme. or with other agency action carrying the force of law. 2022 WL 17348351, at *4. at 1682 (Thomas, J.

FDA 59

FDA Governance Nurses 59

Drug & Device Law

JANUARY 30, 2023

280 (1995), decision that he joined in 1995 He joined a decision that found no preemption by virtue of a governmental decision not to regulate in Myrick and did not object to boilerplate description of obstacle preemption as an accepted preemption category Then in the 5-4 Geier v. Mensing , 564 U.S. Davidowitz , 312 U.S. Davidowitz , 312 U.S.

FDA 72

FDA Fraud Governance Medicare 72