MEDIcept Insights
Understanding FDA’s NEW Draft Guidance on the De Novo eSTAR Program
While the FDA has issued extensive guidance to outline premarket submission requirements and relevant acceptance criteria, manufacturer discretion in the implementation of these requirements often results in a lack of uniformity in the way submissions are prepared and...
FDA’s NEW Final Guidance on the Breakthrough Devices Program
On September 15th, 2023, the FDA issued an updated final guidance on the Breakthrough Devices Program. As established by section 515B of the Federal Food, Drug, and Cosmetic Act, the Breakthrough Devices Program is intended to expedite the development and review of...
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...