The 8th EAAR Annual Conference on New Medical Device Regulations (RMD2024) will take place in Brussels, Belgium, on 26-27 February 2024, featuring speakers from across the MedTech industry, including regulators and notified bodies. Organized by the European Association of Authorised Representatives (EAAR), the conference serves as an inclusive platform for all stakeholders across the both medical…

The US Food and Drug Administration (FDA) has issued two guidance documents relating to the use of the eSTAR (electronic Submission Template And Resource) submission process, which became the mandatory route for 510(k) submissions on 1 October 2023. The two guidances are: Electronic Submission Template for Medical Device 510(k) Submissions: Guidance for Industry and Food…

Donawa Lifescience VP Operations and Clinical Affairs, Daniela Karrer, and Director, Clinical Affairs, are both scheduled to deliver papers at The American Conference on Clinical Trials and Regulation of Medical Devices, taking place in Orlando, Florida, USA, from 20 to 21 November 2023. The conference is intended to be of special interest to regulatory affairs,…

The US Food and Drug Administration (FDA) has announced the finalization of guidance to help institutional review boards (IRBs), clinical investigators, and sponsors comply with informed consent regulations for clinical investigations. The 61-page guidance revises a draft guidance issued in July 2014 and supersedes a guidance issued in September 1998. The document provides general guidance…

The industrry association for medical device notified bodies, TEAM-NB, explains that while extending the deadline for transition to EU Medical Device Regulation (MDR) compliance has been a positive move, there is more regulators and industry can do to ensure manufacturers can recertify their products on time to meet the new deadlines. In its recently issude…

The US Food and Drug Administration (FDA) has announced the user fees that will be payable by medical device manufacturers for interactions with the Agency’s Center for Devices and Radiological Health (CDRH) during Fiscal Year 2024, starting on 1 October 2023. The new fees, which include an increase of around 7.6% over the previous year,…