Latest Articles
Explore our most recent posts below, and be sure to check back often for new content that can help you streamline your operations and achieve success in the competitive medical device market.
RUOs, LDTs, and FDA Enforcement
Despite the 2025 court decision vacating the FDA’s LDT Final Rule, labs and manufacturers aren’t off the hook. This article explores how the FDA is shifting enforcement to RUO labeling and IVD misuse to maintain oversight of unregulated diagnostics.
What is the difference between RA & QA?
What’s the Difference Between Quality Assurance and Regulatory Affairs? If you’re navigating compliance in a small or early-stage medical device company, chances are you’ve come across two essential terms: Quality Assurance (QA) and Regulatory Affairs (RA). These...
What Does GMP-Exempt Mean?
GMP exemption status is often overlooked but critically important in medical device classification. This post explains how it affects your quality system obligations, which are separate from product classification, and why checking that field in the FDA database can reshape your compliance and documentation strategy.
Your Data, Your Responsibility
Update, August 2026: A third lab, and a distinction worth understanding On June 25, 2025, FDA issued a Good Laboratory Practice warning letter to CCIC Huatongwei International Inspection Co., Ltd. in Suzhou, China, following a January 2025 inspection. The findings...
Risk Inputs in ISO 13485
ISO 13485 Made Simple: Using Risk to Guide Your Quality System ISO 13485 requires that medical device companies use a risk-based approach in their quality systems. That means the more risk something poses to product safety or compliance, the more carefully it needs to...
How-to: Facility Registration
How to Complete FDA Annual Facility Registration: A Step-by-Step Overview This video highlights the step-by-step process for completing the FDA annual facility registration, a mandatory requirement for medical device businesses operating under FDA jurisdiction. The...
Value of Supplier Audits
Are Supplier Audits Required? No Neither ISO 13485 nor FDA 21 CFR explicitly require supplier audits, although supplier audits are one mechanism of qualification. The requirements established in FDA and ISO rules are: • Companies must define evaluation and selection...
LDT and IVD Info Hub
!!UPDATE MAR 31, 2025 - The LDT Final Rule was overturned in court!! Get more info from ACLA ---------------------- From October 2024 ------------------------------- Summary of the issue: FDA announced new actions to strengthen the safety and effectiveness of...