Guidance

EU medtech companies are subject to many legislative requirements that ensure devices are cybersecure, but more investment in digital literacy is needed to keep Europe safe from cyber breaches, MedTech Europe says in a new policy paper.

EU guidance on clinical evidence requirements for medical device software does not yet include AI-specific information. An expert group explains how regulators can determine how much evidence is needed for AI-based devices and why common standards should be utilized.

The FDA’s long-awaited guidance on decentralized clinical trials underscores the importance of digital health tech in clinical trials.

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 30 documents have been posted on the tracker since its last update.

NICE, CADTH and ICER say they have taken a step toward greater transparency of unpublished data and a tangible outcome resulting from cooperation among global health technology assessment bodies.

The European Medicines Agency has published a keenly awaited guidance document on how to use computerized systems in clinical trials while ensuring data integrity and patient rights.

In its latest cybersecurity guidance document, the International Medical Device Regulation Forum outlines why medical device manufacturers should ensure that each component of their device is cybersecure and how this can be done.

Abbott landed a surprise US FDA approval for the FreeStyle Libre 3 glucose monitoring system. Also this week: updated guidance documents on software (UK) and angioplasty catheters (US), FDA clearances for Candesant and Moximed, new regulatory requirements for spinal spheres, and a warning on Halyard masks. 

The FDA’s highly anticipated predetermined chance control plan (PCCP) guidance document is pretty much what the industry expected, Sidley Austin partner Deeona Gaskin told Medtech Insight.

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Forty-four documents have been posted on the tracker since its last update.

The US FDA is giving sponsors a grace period of six months before it will issue “refuse to accept” decisions for premarket submissions for cyber devices that lack the information required under recent cyber amendments.

The documents describe the US agency’s preferred approach toward products cleared under EUAs or other alternate approaches during the COVID-19 public health emergency.