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Contingency Planning: Guidance Doc Details Handling Clinical Trials During Emergencies

The agency urges sponsors to keep patient safety “first and foremost” in determining how to continue a clinical trial during a natural disaster, public health emergency, or other crisis.

Policy FDA

Postmarket Surveillance Continues To Challenge AI/ML Device Regulators

Postmarket surveillance of AI/ML is a continuing issue for regulation, DHCoE acting assistant director MiRa Jacobs says.

Artificial Intelligence Regulation

New FDA Documents On Weight-Loss Devices, Software And International Harmonization As End Of Fiscal Year Nears

With the end of fiscal 2023 just over a week away, the US Food and Drug Administration has been publishing promised guidance documents, action plans and white papers.  Medtech Insight’s round-up of four device-specific documents is below.

Guidance Documents FDA

FDA Updates Breakthrough Devices Guidance To Improve Health Equity

The US FDA has updated its final guidance to clarify use of the Breakthrough Devices Program in advancing health equity. The voluntary program was created to speed up the process of getting innovative medical devices to patients that treat life-threatening or debilitating diseases.

FDA Policy

CMS Promises Actions To Support TCET Pathway

CMS has released a list of actions and guidance documents it plans to take to support the TCET pathway.

Medicare Medicaid

FDA Issues Guidance On Biocompatibility Testing For Devices That Make Contact With The Human Body

The US FDA has issued final guidance to assist developers in preparing various applications for medical devices that come in contact with the human body. The guidance also seeks to clarify the use of international standards in assessing device biocompatibility.

FDA Guidance Documents

Q&A Guidance Clarifies Human Factors Testing For Combination Products

A highly anticipated final guidance from the FDA on Human Factor Studies answers frequently asked questions about human factor studies when designing combination products. 

Guidance Documents Regulation

FDA Issues Three Draft Guidance Documents In Ongoing Effort To Improve 510(k) Submissions

As part of its ongoing effort to modernize its premarket notification 510(k) program, the US FDA has issued three draft guidance documents it says will improve the safety of critical medical devices and strengthen the submission process.

FDA Policy

Global Medtech Guidance Tracker: August 2023

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

Guidance Documents Regulation

OTS Software Guidance Update Underscores Industry Advancements

The Off-the-Shelf Software Guidance updates highlight industry advancements.

Regulation FDA

‘Significant Changes’ To Research Ethics Review Rules In Australia Include New Risk Model

Researchers, research offices and ethics committees are being encouraged to familiarize themselves with the new National Statement on Ethical Conduct in Human Research before it becomes applicable on 1 January 2024.

Australia Clinical Trials

Canada Updates 18-Year-Old Guide On What Constitutes Advertising

Keeping press releases about a product on the manufacturer's website landing page for more than a year may be considered to be promotional, according to Health Canada's update guidance that includes myriad revisions, including a new section on using social media.

Canada Advertising, Marketing & Sales

FDA Updates Guidance On Informed Consent In Drug And Device Trials

The revision adds additional discussion of coercion and patient compensation, as well as a new FAQ discussing special situations.  It was coauthored by the Office of Clinical Policy, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, and the Center for Devices and Radiological Health.

Clinical Trials Policy

NIST Cybersecurity Framework 2.0 Expands Guidance’s Scope, Introduces ‘Govern’ Function

NIST released the second version of its Cybersecurity Framework, emphasizing the importance of cybersecurity across sectors.

Cybersecurity Guidance Documents

Global Medtech Guidance Tracker: July 2023

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

Guidance Documents Regulation

FDA Seeks To Spur Innovation In Devices Designed To Treat Opioid Abuse

Draft guidance from the US Food and Drug Administration provides recommendations for the development of medical devices to treat opioid use disorder and considerations for sponsors of clinical studies to evaluate them.

FDA Policy
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