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 document will become effective 6 months after publication (10 September 2023). The written procedure for incident reporting was inadequate.

FDA 40

FDA Licensing Governance Compliance 40

SQA

DECEMBER 16, 2022

This guidance will help applicants interpret how to implement Essential Principles of Medical Device Safety and Performance using information that was issued in March 2020. It will also facilitate cross-border circulation of these critical health therapies as well as cross-border cooperation between public health authorities.

FDA 40

FDA Compliance COVID-19 Licensing 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.

FDA 52

FDA Compliance COVID-19 Public Health 52