Skip to main content
search
Tag

FDA

FDA updates Regulatory Affairs NewsletterFDA Updates Regulatory Affairs Newsletter Archive

U.S. FDA weekly update (WC 18 Dec)

FDA publishes a draft guidance on Real World evidence FDA is issuing this draft guidance to clarify how FDA evaluates real-world data (RWD) to determine whether they are of sufficient quality for generating real-world evidence (RWE) that can be used in FDA regulatory decision-making for medical devices. This draft guidance also proposes expanded recommendations to the 2017 guidance, Use of Real-World…
admin
December 20, 2023
Other Updates Regulatory Affairs NewsletterOther Updates Regulatory Affairs Newsletter Archive

Swissmedic weekly update (WC 06 Nov)

Please note this is an extract of the original bulletin. New information on submitting vigilance reports for medical devices Swissmedic has revised the information on submitting vigilance reports (incidents, trend reports and FSCA reports) for products according to the Medical Devices Ordinance (SR 812.213) and the Ordinance on In Vitro Diagnostic Medical Devices (SR 812.219)
admin
November 10, 2023
Other Updates Regulatory Affairs NewsletterOther Updates Regulatory Affairs Newsletter Archive

Swissmedic weekly update (WC 30 Oct)

Obligations for authorised representatives, importers and distributors The Medical Devices Ordinance (MedDO; SR 812.213) and the Ordinance on In Vitro Diagnostic Medical Devices (IvDO; SR 812.219) set out requirements and responsibilities for operators in the medical devices supply chain. The following Information sheet outlines the roles and obligations of the Swiss authorised representative, the importer and the distributor. It also…
admin
November 3, 2023
FDA updates Regulatory Affairs NewsletterFDA Updates Regulatory Affairs Newsletter Archive

U.S. FDA weekly update (WC 30 Oct)

FDA Establishes New Advisory Committee on Digital Health Technologies The US FDA have formed a new Advisory Committee on Digital Health Technologies (DHTs) to help address different issues related to DHTs such as artificial intelligence/machine learning (AI/ML), augmented reality, virtual reality, digital therapeutics, wearables, remote patient monitoring and software. The committee will also advise the FDA on these issues, providing…
admin
November 3, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA and international partners publish guiding principles for machine learning-enabled medical devices

MHRA, U.S. Food and Drug Administration (FDA) and Health Canada have jointly released 'Predetermined Change Control Plans for Machine Learning-Enabled Medical Devices: Guiding Principles' In this document, MHRA, FDA and Health Canada have jointly identified 5 guiding principles for predetermined change control plans (PCCP). These principles draw upon the Good Machine Learning Practice (GMLP) guiding principles. PCCPs provide a new…
admin
October 27, 2023
FDA updates Regulatory Affairs NewsletterFDA Updates Regulatory Affairs Newsletter Archive

U.S. FDA weekly update (WC 23 Oct)

Webinar - Proposed Rule: Medical Devices; Laboratory Developed Tests On September 29, the U.S. Food and Drug Administration (FDA) announced a proposed rule which aims to end enforcement discretion on Laboratory Device Tests (LDTs). This means, under this proposed rule, that LDTs will be regulated a medical device and it will be covered under the requirements of Food, Drug and…
admin
October 27, 2023
FDA updates Regulatory Affairs NewsletterFDA Updates Regulatory Affairs Newsletter Archive

U.S. FDA weekly update (WC 25 Sept)

FDA Proposes Rule Aimed at Helping to Ensure Safety and Effectiveness of Laboratory Developed Tests | FDA On September 29, the U.S. Food and Drug Administration (FDA) announced a proposed rule which aims to end enforcement discretion on Laboratory Device Tests (LDTs). This means, under this proposed rule, that LDTs will be regulated a medical device and it will be…
admin
October 6, 2023
FDA updates Regulatory Affairs NewsletterFDA Updates Regulatory Affairs Newsletter Archive

U.S. FDA weekly update (WC 18 Sept)

Please note this is an extract of the original bulletin. CDRH Issues Updated Final Guidance on the Breakthrough Devices Program The U.S. Food and Drug Administration (FDA) issued an update to the final guidance: Breakthrough Devices Program. The updates align with the actions outlined in the FDA’s Center for Devices and Radiological Health (CDRH) Strategic Priorities to Advance Health Equity…
admin
September 29, 2023
FDA updates Regulatory Affairs NewsletterFDA Updates Regulatory Affairs Newsletter Archive

U.S. FDA weekly update (WC 04 Sept)

Please note this is an extract of the original bulletin. FDA Issues Guidance and Requests Comments as a Part of Ongoing Efforts to Modernize the Premarket Notification Program To modernize the 510(k) Program to improve the safety of medical devices, the U.S. Food and Drug Administration (FDA) issued the following three draft guidance intended to support efforts to continue to…
admin
September 15, 2023
Other Updates Regulatory Affairs NewsletterOther Updates Regulatory Affairs Newsletter Archive

Swissmedic weekly update (WC 04 Sept)

Please note this is an extract of the original bulletin. SwissGMDP database Swissmedic is bringing a SwissGMDP database into operation, similar to the European Medicine Agency's (EMA) EudraGMDP database. The SwissGMDP is expected to be launched on the Swissmedic website in the last first quarter of 2024, with the exact date to be announced in the coming months.
admin
September 15, 2023
Close Menu