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Regulatory

regulatory

DTA works closely with the Federal Drug Administration (FDA) and Health Canada on your behalf to educate these government agencies on ways to streamline processes to get dental products approved for the marketplace. By providing real-world solutions and resources for our member companies, members are better prepared to tackle the maze of 510(k) submissions, (European Union CE Marks) UDI, and paperwork for exports. Get answers to your domestic and international regulatory questions with the help of FDA consultants (including current DTA members) who work closely with the DTA. Keep up to date on regulatory laws and procedures with our quarterly Regulatory E-Newsletter.

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DTA/fda program & regulatory workshop

2021 Program Information Coming Soon

Manufacturers and distributors do not want to miss this exclusive access annual Regulatory Affairs Meeting with FDA’s Center for Devices and Radiological Health. This workshop provides a great chance for members to learn about new changes in the dental device world and to interact directly with the FDA and their staff reviewers. Take it a step further on Day 1 with a working lunch with FDA Device Reviewers, where participants can gather and ask questions to get answers about product applications and 510(k) submissions.

Consulting

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:

  • UDI
  • Changes to FDA Rulings
  • FDA Audits
  • Counterfeit and Gray Market Goods
  • Health Canada
  • Product Recall Information
  • 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
Consultation Form


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.

Resources

In order to quickly assist members on regulatory and export issues, the DTA has compiled a list of links to important resources. Please note that DTA does not explicitly endorse any of the information and services offered by these sites. They are listed strictly for members’ convenience. For personal recommendations and assistance, please contact us.


DTA keeps members informed about any proposed changes to current FDA regulatory policies including 510(k) submissions for medical devices. FDA is regularly revamping and streamlining the current 510(k) process. This can often involve a proposed change to electronic paperwork (and notes) filings and required software instructions. 510(k) issues are typically covered in the DTA regulatory e-newsletter. Occasionally, DTA sends out e-mail alerts when important deadlines or notifications are required.

DTA also has product submission experts available who can assist members as they navigate the FDA maze of required paperwork and product safety testing filings including Blix Winston, a past FDA officer who has worked on hundreds of 510(k) product submissions, and Claude Berthoin, who has 25 years of experience in the dental industry. Claude, a member of the DTA, is also the owner of 510k FDA Consulting, a Florida based regulatory consulting firm. The company has successfully filed numerous 510(k)s since 1990 for domestic and international clients. By consulting with these regulatory experts, member companies will shorten the 510(k) submission process and save time and money.


In September 2013, FDA (through a Congressional mandate) announced a new series of regulations designed to make it easier to track medical devices as they move through the supply channel chain. The Unique Device Identification (UDI) system requires manufacturers (and distributor’s private label products) to carry a unique bar code (similar to bar codes on grocery store products) on the package or the device itself. (In some cases, a direct mark is required on certain implantable devices).

Deadlines for UDI bar codes on the device or the packaging:

  • September 2014 for Class III devices
  • September 2016 for Class II devices
  • September 2020 for Class I devices

As you navigate the UDI guidelines and implementation requirements, DTA provides some informative articles about UDI that may answer some questions your company may have:

Permission to link to articles granted by http://www.meddeviceonline.com/.

If you have further questions about UDI, please contact us for regulatory guidance and consulting.


  • 510kfda.com: Provides consulting on FDA 510(k) submissions. It also has affiliated offices in Europe, China, and Brasil to assist with regulatory matters in those markets.
  • Emergo Group: Offers on-site consultation on international regulations and/or quality assurance.
  • Export.Gov: Brings together regulatory and export resources from various U.S. government agencies. Medical device regulatory profiles can be found here.
  • Export-Import Bank: The official export credit agency for the United States, which helps to finance and insure the export of U.S. goods and services to international markets.
  • GS!USA: For assistance with UDI barcodes and ways to upload data on to the GUDID website.
  • Infobel: International telephone directory.
  • International Accreditation Forum (IAF): World association of Conformity Assessment Accreditation Bodies and other bodies interested in conformity assessment in the fields of management systems, products, services, personnel and other similar programmes of conformity assessment.
  • PRSGroup: Provides political risk analysis for more than 100 countries.
  • Suvison: Reference resource for world dental news, events, companies, and organizations.

  • TradePort: Repository of free information and resources for businesses that seek to conduct international trade to and from China.

  • MDSS: A provider of Authorized Representative Services and a resource for regulatory information in Europe.
  • TED: Tender Electronic Daily is the online version of the “Supplement to the Official Journal of the European Union”, dedicated to European Public Procurement. Members can search public procurement notices for new business opportunities.
  • Thema: Provides regulatory consulting for medical devices in Europe. Affiliated with 510kFDA.com.

  • TradeEasy: A search engine for products from Hong Kong and China.
  • China Certification Newsletter: Offering the latest information on getting devices certified in China with updated newsletters keeping manufacturers well informed.