In 2011, regulatory consultant Blix Winston replaced Dr. Neal Dunning, who retired from consulting work. Mr. Winston has a strong background in the medical device field, having worked as an official at FDA in the branch office of Devices and Radiological Health for more than 20 years. He contributes a number of articles for the newsletter and has worked on hundreds of 510(k) product submissions. As with Dr. Dunning, Mr. Winston acts as an advisor to DTA and the DTA Regulatory Affairs Committee. Also, he will work as a consultant on behalf of DTA members for 510(k) submissions and other issues. The first consultation is always free. Additional consultations are fee based and DTA members enjoy substantial discounts.
In addition to Mr. Winston, DTA members can also consult with Claude Berthoin, a long-time DTA member. Claude has a law degree and a MBA in International Business. Involved in the international dental trade since 1990, he filed a 510(k) for the Audioprat Endoscope and is recognized as a pioneer in dental imaging. Today, Claude owns Denterprise International, Inc, a dental manufacturer, and 510kFDA.com, a regulatory consultancy with affiliates in North America, Europe, Brazil, Mexico and Asia. He is also a member of the DTA Regulatory Committee.
DTA has additional product submission experts available who can assist members as they navigate the FDA maze of required paperwork and product safety testing filings. Our knowledgeable staff can also assist you with a number of other inquiries including:
- Changes to FDA Rulings
- FDA Audits
- Counterfeit and Gray Market Goods
- Product Recall Information
- Health Canada
- Importing/Exporting into Canada and Mexico
- How to get CE Marks for the EU
- Chinese and Indian Regulatory Affairs
- Finding an authorized distributor in another country that can assist with getting regulatory approval to sell in that country
- Providing additional regulatory consultant information.
Note: Regulatory assistance and consultation is an exclusive benefit for DTA members. If you are interested in taking advantage of this benefit or learning more about how DTA can help you grow your business, please inquire about membership.