USA – New FDA guidance offers ethical roadmap for including children in clinical trials
The US Food and Drug Administration (FDA) has issued draft guidance outlining a series of ethical considerations for conducting clinical trials that involve children.
The guidance,...
USA – Diversity plan draft guidance on track before year end, FDA official says
The US Food and Drug Administration (FDA) is on track to publish a draft guidance on diversity plans before year’s end, which will take...
USA – FDA issues roadmap to medical device regulatory guidance topics list for 2023
The US Food and Drug Administration has released a list of guidance documents it plans to issue over its 2023 fiscal year. FDA’s Center...
USA – Evidentiary Expectations for 510(k) Implant Devices
As part of FDA’s Medical Device Safety Action Plan: Protecting Patients, Promoting Public
Health (herein referred to as the “Safety Action Plan”), FDA committed to...
USA – FDA Proposes New Ban of Electrical Stimulation Devices for Self-Injurious or Aggressive...
Today, the U.S. Food and Drug Administration (FDA) is proposing a ban of electrical stimulation devices (ESDs) intended to reduce or stop self-injurious or...
USA – Content of Premarket Submissions for Device Software Functions
This guidance document is intended to provide information regarding the recommended documentation for premarket submissions for FDA’s evaluation of the safety and effectiveness of...
USA – Existing software development lifecycle tools can help speed AI/ML products to market
Software developers creating artificial intelligence/machine learning (AI/ML) medical products should move forward with the software development lifecycle (SDLC) models they are already familiar with...
USA – FDA wants COVID test developers to shift from EUAs to traditional premarket...
The US Food and Drug Administration (FDA) has released updated guidance on COVID-19 diagnostic and serology testing, signaling its intention to review fewer emergency...
USA – FDA recognizes new medical device sterilization standards
Amid a regulatory effort by the US Environmental Protection Agency (EPA) to limit the use of ethylene oxide (EtO), the Food and Drug Administration...
USA – Advocacy groups, AdvaMed vie for next phase of TAP pilot
Medical devices that treat brain diseases and disorders should be the next products to be accepted into a US Food and Drug Administration (FDA)...
