Regulations and standards create a maze that can be difficult to navigate. Information on government regulations and standards can be located here. For issues not found in this section, please contact the DTA for other sources of information. The DTA Committee on Regulations and Standards is an active resource for our members. Our regulatory consultant - Neal Dunning - is also a source of information about regulations.

DTA Forum on Dental Branch Activities

This one-day program will include:

• Dr. Harvey Rudolph, ISO Author, Former FDA Representative


• Dr. Larry Kessler, Director, Office of Science and Engineering Laboratories CDRH, FDA


• Dr. Susan Runner, FDA Branch Chief, Dental Devices, Center for Devices & Radiological Health


• Jay Crowley, FDA Senior Advisor for Patient Safety, Center for Devices and Radiological Health

Thursday, May 22^nd
7:30 am - 3:30 pm
Hilton Hotel Gaithersburg
620 Perry Parkway, Gaithersburg, MD   Tel: 301.977.8900

You'll receive ISO Risk Management Training with Dr. Harvey Rudolph, updates from the FDA on Unique Device Identification (UDI), Pedigree Drugs and Global Harmonization Task Force (GHTF). Plus, you'll have networking time with staff of the FDA Dental Branch at lunch, and an afternoon forum with the DTA Regulatory Committee.

The cost to DTA Members is $199 / person, which includes breakfast, lunch and refreshments. Special hotel rates for members requiring an overnight stay are available.

See the flyer and registration form, and register today!

California State Board of Pharmacy has voted to delay any implementation of new pedigree requirements. See an update and background information on this issue.

Plus, recently DTA distributed a summary of the FDA’s implementation plan for Drug Pedigree requirements. Over the course of the last three years, many states have begun programs to require drug pedigrees and many of the programs are more onerous than the FDA’s requirements. We are in the process of researching the state issue, but need your help. If you have specific information about state activities to require drug pedigrees, please forward that information to the DTA office. We will produce a report on state activities.

DTA Wins IAF Support to Form New IAF Working Group for ISO 13485 GeMDCAS
Grant Ramaley, Chairman, DTA Regulatory Affairs and Standards Committee, announced that the DTA had a very successful IAF Meeting last month. Read his letter for more details.

FDA Quality Systems Training Series - 10 CDs for DTA Members
FDA Quality Systems Training for Dental Manufacturers and Distributors. $445 with free shipping.

FDA Changes in Firm Registration and Device Listings: News from DTA's Regulatory consultant may be helpful to you.

Risk Classifications of your Dental Product: These documents provide the quickest and easiest way to identify the risk class of your device, including the regulations and "risk rules" from which they were derived.

• DTA's Dental Device Risk Classification Chart - a 7 page PDF document.
• Link to Health Canada's web site for a 79 page PDF document entitled Keyword Index to Assist Manufacturers in Verifying the Class of Medical Devices.

A Compilation of Worldwide Regulatory Requirements: From DTA's Export Committee, compilation of worldwide regulatory requirements for exporting dental and medical products to industrialized nations.

Neal Dunning provides guidance for industry regarding FDA Export Certificates.

Link to Health Canada's Drug and Health Products - Medical Devices to see information on Quality Systems (ISO 13488 and ISO 13485).

Link to Medical Device and Diagnostic Industry magazine article (May,1999) which is still an excellent article if you're starting to deal with electronic signatures. to see information on Quality Systems (ISO 13488 and ISO 13485).

Link to OSHA HIB 02-04-19 entitled Preventing Adverse Health Effects from Exposure to Beryllium in Dental Laboratories.

Link to A Guide to the EU Medical Device Directive, available as a PDF document or web page, within Technology Services of the National Institute of Standards and Technology (NIST) site.

EmergoGroup, Inc.

• Special Rates for DTA Members for Quality Assurance and Regulatory Affairs.

• Sign up for the EmergoGroup, Inc. Newsletter for news and information affecting medical device and IVD executives.

Neal Dunning Associates: Regulatory Consulting Services are provided at a reduced rate to DTA Members.

We've provided some links to key FDA information:

• Information for FDA-Regulated Industry: www.fda.gov/oc/industry
• Registration and Listing: for firms involved in the production and distribution of medical devices intended for marketing or leasing in the US: www.fda.gov/cdrh/reglistpage.html
• FDA's Human Factors Program - Promoting Safety in Medical Device Use: www.fda.gov/cdrh/humanfactors/resource-manufac.html
• FDA Device Advice: CDRH's self-service site for medical device and radiation emitting product information. www.fda.gov/cdrh/devadvice/index.html
• Quality System Inspections Reengineering (QSIT) - FDA's current thinking on Quality Systems Inspections: www.fda.gov/cdrh/gmp/gmp.html