Blog

Regulatory FDA launches TAP Pilot to speed access to safe and innovative medical devices The FDA has launched the TAP Pilot Program (Total Product Life Cycle Advisory Program) for manufacturers [...]

Regulatory FDA finalizes guidance on how clinical decision support software is regulated FDA has published final guidance on determining whether clinical decision support software is considered a [...]

Regulatory FDA creates new category of OTC hearing aids, issues PSAP guidance FDA finalized a much-anticipated rule that allows certain air conduction hearing aids to be available [...]

The Upper Valley is home to a growing number of MedTech companies that are changing how we detect, monitor and treat a variety of diseases. Simbex was excited to join the Magnuson Center for [...]

Regulatory US FDA’s latest medical device cybersecurity guidance: Key differences from previous versions On April 8, 2022, the US Food and Drug Administration published a new draft [...]

Regulatory MDUFA V: US FDA sets performance goals for De Novo medical device reviews MDUFA V will set performance goals and procedures for medical device submissions for the fiscal years 2023 [...]

Regulatory US FDA formally proposes aligning Quality System Regulations with ISO 13485 The US Food and Drug Administration has published a highly anticipated proposed rule to harmonize its [...]

Regulatory FDA misses MDUFA V deadline after months of contentious talks FDA has failed to send the final Medical Device User Fee Amendments V agreement to Congress by the Jan. 15 deadline. The [...]

Regulatory  FDA expands eSTAR filing to de novo devices, IVDs US medical device and in vitro diagnostic sponsors who are using the Food and Drug Administration’s de novo pathway will be able to [...]