category agency-information 
Health Populi
JULY 28, 2020
This week, announcements from the Consumer Technology Association (CTA) and Withings further bolster the case for the private sector bolstering public health in this pandemic…and future ones to come beyond the Age of the Coronavirus. On 27th July, CTA announced the Association’s launch of the Public Health Tech Initiative.
AIHC
JUNE 14, 2023
AI is advancing rapidly, so we encourage you to reference the new Artificial Intelligence article category for the latest articles. The question remains, how will the use of AI be regulated for health care use? This article only scratches the surface of various regulatory agencies involved in the regulation of AI.
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SQA
FEBRUARY 15, 2023
Eudralex, Volume 4: GMP Guidelines and Annexes Revision of the EU GMP Guide Annex 11 “Computerized Systems” – Presentation of Concept Paper, 18 November 2022 On 16 November 2022, the European Medicines Agency EMA published a concept paper on the planned revision of Annex 11 “Computerized Systems.”
Hall Render
NOVEMBER 30, 2023
On September 29, 2023, the Food and Drug Administration (“FDA”) announced the issuance of a Notice of Proposed Rulemaking (the “Proposed Rule”) to expand the FDA’s regulatory scope over in vitro diagnostics products (“IVDs”) to specifically address Laboratory Developed Tests (“LDTs”).
Bill of Health
OCTOBER 5, 2023
Addressing algorithmic bias at the federal level Following a promise by the Biden Administration in 2022 to conduct an “evidence-based examination of health care algorithms and racial and ethnic disparities,” the Agency for Healthcare Research and Quality (AHRQ), began a systematic review last year.
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.
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.
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