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Regulatory Affairs and Standards Committee

Activities

The Regulatory Affairs and Standards Committee updates and educates members about industry regulations. The committee works closely with the FDA’s Center for Devices and Radiography to help shape regulations and keep DTA members abreast of new regulations.

  • Universal Accreditation: The committee works closely with the International Accreditation Forum (IAF) to pursue universal accreditation of medical and dental devices, which would allow companies to sell products in many international markets while eliminating fees and unnecessary paperwork. 
  • FDA Initiatives: The committee provides input about various FDA initiatives. DTA members have provided input about major FDA initiatives restricting amalgam, relabeling dental device packaging and providing unique device identification. Committee members are instrumental in getting some of the requirements delayed or adjusted to better meet DTA member needs. 
  • E-Newsletter: The committee publishes a quarterly e-newsletters throughout the year, updating and educating members.  Up-to-date information is provided on changes in the device regulatory community including updates from FDA, Health Canada, the European Union and other countries with robus regulatory issues for the approval of selling medical devices.
  • Meetings:  DTA hosts an annual program with the FDA's Center for Devices and Radiography staff in Silver Spring, MD in January/February.
 
Chair: Grant Ramaley (Aseptico) and Napoleon Monroe (New Directions Consulting)
Liaison: Fred Freedman