Sen. Patty Murray, D-Wash., Feb. 4 introduced legislation
that would require FDA to “expeditiously” finish a draft guidance on 510(k) modifications and allow the agency to refuse or...
Following up on recommendations made in her January report on duodenoscope contamination, Senate HELP Ranking Member Patty Murray, D-Wash., introduced a bill pressing FDA to accelerate its work to clarify when 510(k)s are needed for device modifications and to solidify the agency's authority to deny submissions if the sponsor fails to provide validated reprocessing data.
Sen. Patty Murray, D-Wash., Feb. 4 introduced legislation
that would require FDA to “expeditiously” finish a draft guidance on 510(k) modifications and allow the agency to refuse or...
The US FDA needs to know who wants a seat at the MDUFA negotiations table before discussions can begin. The agency is asking stakeholders to let it know if they plan to participate in the periodic consultation meetings before July 28.
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 50 documents have been posted on the tracker since its last update.
Finland has initiated a project to improve the effectiveness of the monitoring of software intended for medical use and to ensure that software placed on its market meets the requirements set for it.