The International Medical Device Regulators Forum (IMDRF) has now released the ‘Outcome Statement’ from its latest meeting, held 11-15 March 2024 in Washington DC, USA. Copies of the report are available from here, which include a note of the decisions made by the ‘regulators only’ closed session, during which eight revised guidance documents were approved…
The US Food and Drug Administration (FDA) has outlined a standardized approach for collecting and reporting on race and ethnicity data in clinical trials and studies in a new draft guidance document. “Using standardized terminology for race and ethnicity helps ensure that data are collected and reporting consistently in submission to FDA,” the agency wrote…
At the MDCG Subgroup on Standards (WG 2) held on 19 January 2024, it was confirmed that for all industrial sectors, the accepted symbol for ‘Authorised Representative’ would change from ‘EC¦REP’ to ‘EU¦REP’. It has been proposed that a two-year transition period would be allowed for product labeling to be brought into line with the…
Misuse of medical devices at home is the most pressing health technology safety hazard, nonprofit patient safety organization ECRI reports. ECRI’s list of the top 10 safety hazards related to medical technology also includes concerns about AI and data security. Since 2008, ECRI has issued its list of the top 10 safety hazards related to…
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…
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,…
