DTA has regularly provided assistance to members om regulatory issues including 510 (k) submissions and general questions regarding FDA rules and changes to the existing regulatory maze. This includes consultants who can assist DTA members with their 510 (k)s and impending FDA inspections.
One of our leading consultants is Claude Berthoin, a long-time DTA member. Claude has a law degree and an 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.