At a recent DTA Regulatory and Standards meeting with the FDA at their Silver Spring campus, FDA Center for Devices and Radiological Health and the Center for Disease Control officials requested that DTA ask for input from industry to develop a better description for a syringe when not used for sterile injection. The term syringe (as used by the dental community) has become very broad. It encompasses hundreds of devices that dispense a variety of non-sterile pharmaceuticals and medical device products. One U.S. dental distributor shows more than 500 syringe listings in their current catalog. FDA and the Center for Disease Control believe it would be in the best interest of practitioners and patients to avoid any possible confusion and develop a more descriptive term than just using the term syringe for a wide range of dispensers.
In March, DTA participated in a meeting of the 2014 ADA Standards Committee on Dental Products (SCDP) in Charlotte, N.C. The SCDP looks at standards for all types of dental products and equipment from basic toothbrushes and sealants to complex devices, including digital radiography and CAD/CAM. The SCDP ensures practitioner and patient safety by determining fundamental design and manufacturing standards that can be easily adhered to in the U.S. by domestic manufacturers and their global counterparts.
All U.S. devices are required to have a unique device identification bar code on the device or the packaging starting in September 2014 for Class III devices, Class II devices by September 2016 and Class I devices by September 2018, but you should be preparing for these changes today. That’s the message DTA members received during the March 5 UDI (Unique Device Identification) Implementation Workshop in Silver Spring, Md., featuring keynote speaker Jay Crowley, former head of the UDI initiative for FDA.
In an effort to address many of the issues affecting the dental industry, the Dental Trade Alliance sat down with members of the U.S. Food and Drug Administration's (FDA) Dental Branch staff. The discussions, which I would characterize as fruitful, ranged from 510(k) marketing clearance submissions, gray-market products and radiological concerns to fluoride and amalgam. We also covered new regulatory rules and changes. While it may seem that these topics won't impact your daily life as a sales representative, knowing more about what's happening at the federal and industry levels can help build and strengthen your relationships with clinicians.
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At the end of January, the Dental Trade Alliance and several representatives from its member companies met with FDA Dental Branch staff. This was the second year that FDA had agreed to meet with DTA and industry representatives. These meetings are part of ongoing communications between the two groups about regulatory changes. As always, there was much to discuss including: 510(k) submissions, electronic 510(k) submissions, gray market products, radiological concerns about pediatric patients, fluoride, dental amalgam, and new regulatory rules or changes.
As a sales representative, you may have fielded questions from dental teams about the impact of health care reform’s Sunshine Act, which requires medical device and/or supply manufacturers to report to the Centers for Medicare and Medicaid Services (CMS), a division of the U.S. Department of Health and Human Services, payments or transfers of value to dentists and dental educators. To help you better answer these inquiries, the Dental Trade Alliance (DTA) has created this seven-point guide.
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To better advocate for you, the DTA has arranged a face-to-face meeting with the FDA Dental Branch Division later this month (December 2012) to discuss a variety of hot topics including 510(k) submissions, gray market products, the Unique Device Identification (UDI) system for the medical device industry, pedigree, pediatric X–ray and other important industry topics. UDI is scheduled to begin implementation in 2013.
Member Alert! The FDA is recommending that manufacturers design new X-ray imaging devices with protocols and instructions that address use on pediatric patients. It also proposes that manufacturers who do not adequately demonstrate that their new X-ray imaging devices are safe and effective in pediatric patients should include a label on their device that cautions against use in pediatric populations. Click here to see the FDA's press release.
In response to regulators’ emphasis on transparency within the health care industry, the American Dental Education Association (ADEA) released guidelines for ethical academic and dental industry interactions.