Guidance
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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.

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.

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.

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.

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.

FDA Issues Three Draft Guidance Documents In Ongoing Effort To Improve 510(k) Submissions
As part of its ongoing effort to modernize its premarket notification 510(k) program, the US FDA has issued three draft guidance documents it says will improve the safety of critical medical devices and strengthen the submission process.

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.

OTS Software Guidance Update Underscores Industry Advancements
The Off-the-Shelf Software Guidance updates highlight industry advancements.

‘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.

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.

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.

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.

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.

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.

WHO Lists Scientific & Ethical Features That All Good Clinical Trials Should Include
In response to a World Health Assembly resolution on strengthening the global clinical trial ecosystem, the World Health Organization has drawn up a new draft guideline on best practices for clinical trials updating and adapting its previous work on research capacity.

CDS Final Guidance Infringes On Free Speech, Professor Says
A citizen petition filed by a University of Florida Law Professor posits that the FDA’s CDS Guidance violates the first amendment.
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