The agency will need to restrain evidence expectations for proving clinical validity in its planned framework for regulating laboratory-developed tests in order to make the framework more feasible, speakers at a Sept. 18 Avalere conference said.
FDA may have to moderate its data expectations for providing clinical validity of laboratory-developed tests if its newly planned framework is going to be feasible to implement, speakers at a Sept. 18 diagnostics policy conference said.
The framework would subject makers of LDTs, which are diagnostic services offered from the same lab in which...
Create an account to read this article
Already a subscriber?
European Commission is expected to have tsunami of responses, including from medtech stakeholders to its public consultation. The US is already intensely interested in developments.
The unwieldy application demands of the EU’s bunch of interconnected data regulations are creating headaches for the medtech industry.
The newly released Unified Agenda, which outlines actions the executive branch plans to take in the coming months, includes several medtech-related proposals.
The American Medical Association says years of advocacy have resulted in Medicare policy changes that are a big win for physicians and patients.
Tandem Diabetes Care initiated a recall last month of several t:slim X2 insulin pumps due to a “malfunction 16” error that can cause the pumps to shut down. The problem is triggered by wiring within the device speaker.
Emma Mittelstaedt Burnham prosecuted antitrust violations in healthcare sector in her previous work at DoJ, including leading investigation into antitrust cartels in the generic pharmaceutical industry.
The US FDA received over two dozen comments from stakeholders on the next round of the medical device user fee amendments, which will establish funding for fiscal years 2028 through 2032.
