Special Report: Preparing for Stage 1 of the FDA’s LDTs Final Rule
Considerations for addressing compliance with Stage 1 of the FDA’s lab-developed tests final rule
Author Information
Rachel Muenz
Rachel Muenz is the managing editor of G2 Intelligence and was previously senior digital content editor at Lab Manager, a publication dedicated to teaching lab professionals the management skills they need to run their laboratories as effectively as possible. She has over 10 years of experience as a writer, editor, and curator of both print and digital content, with the majority focused on laboratory topics. Rachel holds an honors bachelor of arts degree in English from the University of Toronto and a diploma in journalism from Centennial College.
Posts by the Author
Special Analysis: HIPAA Compliance Risks of AI in the Lab: Trends and Tips
The most common AI compliance risk areas related to data security and patient privacy, and the current regulatory landscape
LDTs Rule Update: More Support for Legal Challenges Against FDA
Key clinical laboratory organizations file amicus brief, reiterating that the FDA is overstepping its authority, and its new rule would cause “irreparable patient harm”
Are Current Regulations Keeping Labs from Benefiting from AI?
Though needed to protect data and patient privacy, some in the industry say that more flexibility is needed
Key Developments and Challenges in Laboratory Networks
The current landscape of medical laboratory networks and challenges that will need to be addressed to improve data sharing and efficiency.
New FDA LDTs Guidance Offers Useful Summary, But Questions Remain
Recently released document for small labs offers a more digestible version of the final rule requirements but still lacks key details
When Hiring Laboratory Sales Reps, Managers May Want to Consider Non-Sales Backgrounds
Clinical laboratory sales training expert Peter Francis shares qualities to look for when hiring laboratory sales reps
Expert Q&A: Full Approval for Alzheimer’s Blood Tests Not Far Off
Andreas Jeromin, PhD, chief scientific officer at ALZPath, discusses the current landscape of blood-based AD tests and their future.
Expert Q&A: A Promising Future for Alzheimer’s Blood Tests
Alison Green, PhD, head of laboratory sciences at Scottish Brain Sciences, discusses recent developments in AD blood tests
3 Thoughts on the FDA’s Final LDTs Rule
Regulatory expert Julie Ballard shares her first thoughts on the final rule for lab-developed tests and immediate steps for labs
