FDA QSR UPDATE – ISO 13485 Alligned QMSR Final Rule Getting Closer

By Eric Thorn, Esq Beginning back in the spring of 2018, FDA announced its intent to adopt rules to replace the current quality system regulations (QSR) found in 21 CFR Part 820 with rules more aligned with International Organization for Standardization (“ISO”) standard ISO 13485:2016 (ISO 13485). This year, on February 23, 2022, FDA published…

Digital Workflows: Provide Benefits to Accuracy, Consistency, and Efficiency

Over the last decade, the implementation and optimization of digital workflows have played a vital role in our business. Although we still have several traditional, “analog” components to our workflow, digital integration has delivered a remarkable level of accuracy, consistency, and efficiency across thousands of projects. As a lab that strives for continuous innovation, we…

FDA 510(k) Clearance – An Overview

By Eric Thorn, Esq. Well to start off with, no a 510(k) is not some type of retirement plan, that’s a 401(k).  Section 510(k) is a section of the Food, Drug and Cosmetic Act (FD&C Act) that requires device manufacturers to provide the Food and Drug Administration (FDA) with at least 90-day advance notice of…

UDI & Surgical Guides

With the focus on Covid related business impacts and the delayed implementation, that some of the FDA’s Unique Device Identifier(UDI) program’s labeling requirements have become effective in the latter part of 2020 has not received as much attention as it otherwise may have. One question that has recently arisen relates to the application of UDI…

FDA and Dental Products

For dentists and dental laboratories, the raw materials and equipment/technology used in the delivery of dental services is regulated in some manner by the U.S. Food and Drug Administration (FDA). To help dentists, dental laboratories and patients understand elements of how FDA is involved, this blog is a primer on key questions that many people…