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Set Alert for Guidance

Cybersecurity Skills Shortage In EU ‘Untenable’ Warns Medtech Trade Body

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.

Medical Device Cybersecurity

Clinical Evidence Requirements For AI Must Be Based On Purpose, EU Expert Group Says

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.

Medical Device Artificial Intelligence

Decentralized Clinical Trial Guidance Fulfills Promise, Underlies Digitization Of Healthcare

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

FDA Guidance Documents

Global Medtech Guidance Tracker: April 2023

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.

Guidance Documents Regulation

English, Canadian and US HTA Bodies Team Up On Unpublished Clinical Data Transparency Drive

NICE, CADTH and ICER say they have taken a step toward greater transparency of unpublished data and a tangible outcome resulting from cooperation among global health technology assessment bodies.

Policy United Kingdom

EMA Finalizes Key Guideline On Use Of Digital Tech To Capture Electronic Trial Data

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.

Clinical Trials Digital Health

Latest Cybersecurity Guidance From IMDRF Highlights Software Bills Of Materials

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.

Europe United Kingdom

News We’re Watching: UK Software Guidance, FDA Approvals, Halyard Mask Warning

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. 

Policy Regulation

Expert: FDA’s Highly Anticipated PCCP Guidance Isn’t Anything Too ‘Surprising’

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.

Guidance Documents Policy

Global Medtech Guidance Tracker: March 2023

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.

Guidance Documents Regulation

‘Refuse to Accept’ Decisions For Cyber Devices To Begin In October

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.

Cybersecurity Regulation

FDA Finalizes Guidance Documents Aimed At Easing Post-Pandemic Regulatory Transitions

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.

FDA Guidance Documents
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