The US Food and Drug Administration (FDA) has published its long-awaited Quality Management System Regulation (QMSR) final rule that harmonizes its requirements with the International Organization for Standardization (ISO) standard ISO 13485. The agency said the rule will ensure consistency in regulatory expectations for device makers across regulatory regimes, while saving industry hundreds of millions…
The European Commission has proposed to accelerate the timeline for complying with EUDAMED requirements by making the use of finalized modules mandatory on a gradual basis. Under the current regulations, EUDAMED will not become mandatory until all six of its modules are in place; however, under the proposed revisions, EUDAMED compliance would be rolled out…
Donawa Lifescience VP Operations and Clinical Affairs, Daniela Karrer, and Director, Clinical Affairs, both delivered papers at The American Conference on Clinical Trials and Regulation of Medical Devices, which took place in Orlando, Florida, USA, from 20 to 21 November 2023. The conference was intended to be of special interest to regulatory affairs, clinical trials,…
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…
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 The 61-page guidance revises a draft guidance issued in July 2014 and supersedes a guidance issued in September 1998.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,…
The announcement by the UK Government Department for Business and Trade (DBT) on 1 August 2023, that a broad acceptance of CE marks instead of the UKCA mark for the forseeable future, briefly caused confusion among the medical device community, considering that only weeks before had the transition deadlines for legacy medical devices been extended…
The latest news from the European Commission is that a fully functional EUDAMED is now not likely to be available until late 2026. Originally scheduled to be completed in May 2020, the much delayed roll-out is now taking place in phases, rather than all modules at one time. While some modules are already available, European…
The US Food and Drug Administration (FDA) has updated and expanded its list of premarket medical device consensus standards that include important topics such as medical device cybersecurity, sterilizing products using radiation and using certain materials and alloys. FDA published tables on 1 August listing voluntary consensus standards that are either withdrawn, replaced, corrected or…
