In the past decade, the FDA has increased the number of device manufacturing establishment inspections. Pre-COVID, in 2017, the FDA conducted 2,952 inspections of medical device firms, representing a 46 percent increase compared to a decade earlier. FDA also increased foreign inspections 243 percent. In 2018, FDA regional field offices launched inspections of dental laboratories…
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…
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…
By NADL Executive Director Bennett Napier, CAE This general timeline of activities, covering key moments in the last ten years, is intended to provide clarity on the classification system of occupations used by the U.S. Department of Labor (DOL), including dental laboratory technicians. For background, the O*Net system classifies occupations based on the following criteria:…
In the realm of global dentistry, health and safety processes and procedures have always been stringently regulated. Protec Dental Laboratories LTD, Vancouver, BC, Canada, places great emphasis in following internal and external regulatory guidelines that are predominantly outlined by both the Provincial Ministry of Health and College of Dental Technicians of BC. Pre COVID-19, disinfection…
By Raleigh F. “Sandy” Seay Historians tell us that plagues or pandemics or epidemics are not uncommon in the continuing narrative of the Long Debate. In the last two centuries, we have seen the Spanish Flu, the Asian Flu, the Hong Kong Flu, Severe Acute Respiratory Syndrome (SARS) and now, COVID-19.(1) COVID-19 has run rampant…
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…
Q&A with Mary Borg-Bartlett and Gary D. Morgan, CDT, ASQ CQA of SafeLink Consulting, Inc. Safety of workers and patients is not an easy task in these difficult times. Dental labs must consider not only the regulatory side of protecting workers but also the practical side of how to manufacture under constraints being placed on…
Eliminating hazards from COVID-19 remains a top priority for OSHA. As workplaces reopen, OSHA will continue to ensure safe and healthy conditions for America’s working men and women and has released the following: https://www.osha.gov/memos/2020-05-19/updatedinterim-enforcement-response-plan-coronavirus-disease-2019-covid-19. In geographic areas where community spread of COVID-19 has significantly decreased, OSHA will return to the inspection planning policy that OSHA…
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…