Process to Request a Review of FDA's Decision Not to Issue Certain Export Certificates for Devices

USA – Process to Request a Review of FDA’s Decision Not to Issue Certain...

The FDA is issuing this guidance document to comply with section 704 of the FDA Reauthorization Act of 2017 (FDARA) (Public Law 115-52), which amended section...
FDA updates safety recommendations on biotin interference in lab tests

USA – FDA updates safety recommendations on biotin interference in lab tests

The U.S. Food and Drug Administration (FDA) is updating our 2017 safety communication to remind the public, health care providers, lab personnel, and lab...
CRADA report from UL and US VA: Procurement as driver of medical device cybersecurity

USA – CRADA report from UL and US VA: Procurement as driver of medical...

A new report issued by the US Department of Veterans Affairs and UL suggests that along with regulation, procurement policies at healthcare purchasing organizations...
Trump Nominates Hahn to be FDA Commissioner

USA – Trump Nominates Hahn to be FDA Commissioner

President Donald Trump on Friday nominated Stephen Hahn, chief medical executive of the MD Anderson Cancer Center in Houston, to be the next US...
Developing the Tools to Evaluate Complex Drug Products: Peptides

USA – FDA Proposes Additional Class II Devices to be Exempt From 510(k) Requirements

Thanks to the 21st Century Cures Act, the US Food and Drug Administration (FDA) on Thursday proposed to exempt additional class II medical devices under...
Breast Implants - Certain Labeling Recommendations to Improve Patient Communication

USA – Breast Implants – Certain Labeling Recommendations to Improve Patient Communication

I. Introduction This draft guidance contains recommendations concerning the content and format for certain labeling information for saline and silicone gel-filled breast implants. FDA is...
Brazil’s ANVISA proposes updates to medical device, IVD registration requirements

Brazil – Brazil’s ANVISA proposes updates to medical device, IVD registration requirements

Brazilian medical device market regulator ANVISA has issued two new consultations proposing changes to longstanding regulations of medical devices and IVD products. The regulator will...
Determining the Clinical Benefit of Treatment Beyond Progression with Immune Checkpoint Inhibitors

USA – Newly Added Guidance Documents

Below is a sortable list of the most recently added Guidance Documents. You can sort alphabetically by: Category/Subject Area; Guidance Title; Guidance Type (Draft or...
AAMI TIR102:2019

USA – AAMI TIR102:2019

U.S. FDA 21 CFR mapping to the applicable regulatory requirement references in ISO 13485:2016 Quality Management Systems This document provides a mapping of the US...
Metals Used in Medical Devices

USA – Metals Used in Medical Devices

Metals and metal alloys are commonly used in implanted medical devices and in inserts like amalgam dental fillings, and these materials are sometimes in...

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