NEW FDA Guidance on Human Factors Engineering for Combination Products!
Introduction to the Final Guidance FDA recently published a final guidance document, “Application of Human Factors Engineering Principles for Combination Products: Questions and Answers.” This question-and-answer formatted document aims to clarify and provide...
FDA’s NEW Final Guidance on Use of ISO 10993-1 “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process”
Introduction to the Final Guidance On September 8, 2023, FDA issued the new final guidance “Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process".” The aim of this...
Is Your Product a Medical Device or a Borderline Product?
The demand for medical devices in the UK has soared, prompting manufacturers to navigate complex classifications. While global acceptance is a factor, it doesn’t always align with the standards set by the MHRA. To ensure compliance, manufacturers must decode the UK’s...
FDA Updates Their CLIA Waiver Process
The FDA has updated their CLIA Waiver Process in the following ways: CLIA Waiver by Application The FDA has updated its CLIA waiver process to provide manufacturers of in vitro diagnostic (IVD) tests with clearer guidelines and requirements. Under the Clinical...
Breakthrough Devices Program Updates Device Designations Data and Marketing Authorizations List
The Breakthrough Devices Program is consistent with the FDA’s mission to protect and promote public health by helping, through a prioritized review, expedite the development, assessment, and review of a device all while considering statutory standards. The voluntary...
LDTs and Oncology Companion Diagnostics Pilot Program – One More Step into FDA Regulating LDTs!
Introduction While many common laboratory tests are commercial tests, manufactured and marketed to multiple labs, some tests are designed, manufactured, and used within a single laboratory. These tests, called “laboratory-developed tests” or “LDTs” are supposed to be...