A recent FDA warning letter shows what separates a defensible letter to file from a thin one. The difference is the design change assessment behind it, and how well it connects to complaints and CAPA.
A New Statutory Attempt at LDT Oversight
HR 8890 would keep LDT oversight with CMS under CLIA and add a public validation database, serious harm reporting, and optional third-party review.
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.
How to Hold a Management Review
Streamline your next management review with our free agenda template. Designed to meet both FDA and ISO 13485 requirements, it helps ensure compliance, clear documentation, and efficient oversight without starting from scratch.
How to Find a Contract Manufacturer
Learn how to search the FDA Establishment Registration & Listing database to verify device manufacturers, suppliers, and contract partners. Practical tips for quality and regulatory professionals.
2025 FDA Warning Letter Trends
FDA warning letters in the first half of 2025 highlight recurring issues with Medical Device Reporting and complaint handling. From missing procedures to delayed submissions, the same preventable mistakes appear again and again putting companies at risk.
What is a Risk-Based Approach?
Risk-based thinking is more than a buzzword, it is the foundation of a smart and effective QMS. This post shows how to apply risk-based thinking practically across audits, CAPAs, supplier management, and training, so you can prioritize what matters, avoid unnecessary compliance burdens, and become a true strategic partner.
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.
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...
Warning Letters
Update: This post was written in October 2024 when FDA first announced the action. FDA has since gone further, rejecting all study data from both facilities, and we have written a fuller piece on what this means for your supplier qualification program. For the current...