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 Regulatory Issues is an active resource for our members. Our regulatory consultant, Blix Winston, is also a source of information about regulations.

DTA Regulatory E-Newsletter: July

See the entire July Regulatory Newsletter PDF.

DTA to Comment on New FDA Guidance

At the June FDA Reprocessing Reusable Medical Devices Conference, FDA staff presented new draft guidance that affects most DTA members. Several important take-away points for the dental device industry were raised at the conference.
Learn more...

May 5, 2011
2011 DTA Forum On Dental Branch Activities
Regulatory Forum with FDA Dental Division Executives

Please check back for re-scheduled date.

Medical Device User Fees for FY 2011 Announcement

September 14, 2010

The U.S. Food and Drug Administration (USFDA), Center for Devices and Radiological Health (CDRH) would like to inform you that a letter announcing the Medical Device User Fees for FY 2011 was issued and sent worldwide to over 21,000 registered device establishments. Here's a direct link to the PDF of the letter on the FDA's site. This is for October 1, 2010 through September 30, 2011.

Notes from Dr. H. Neal Dunning regarding the FDA's website redesign

You may be able to save yourself some time and learn more from the FDA's website with these navigation and content notes. Dr. Dunning's note contains additional guidance for navigating the FDA website for import and export medical device information.

Adopting the Existing International Approach for Item Identification: The Customers' Key is Maintaining Interoperability Across all Commodities!!

PowerPoint show by Mr. Rob Liebrandt, Deputy, UID Policy Office, Office of the Secretary of Defense, Defense Procurement from DTA's Annual Meeting, August 12, 2009

EUROPEAN REGULATORY COMPLIANCE - REACH
Registration, Evaluation, Authorization and Restriction of Chemical substances

A number of our members are struggling to meet a new European Directive known as REACH. This regulation requires that manufactures of chemicals or manufacturers of products that leach chemicals make sure their chemicals are registered. This has created far more of a problem for European based manufacturers, since all the chemicals that they buy and use have to be registered. It does not apply to medical device manufacturers in the United States who buy and use chemicals that do not leach from their finished products.

BOMcheck – REACH registration made easier
Industries in Europe have banned together to create a system for registering their chemicals using a new electronic registration system called BOMcheck (www.bomcheck.net). It can also be used to look up chemicals that are already registered. Sharing REACH registration information and reducing the effort to get chemical registered has never been easier.

At the Bomcheck website you will also find a free webcast explaining what REACH is, and how to use BOMcheck for compliance. If you have been struggling with compliance with the REACH directive, we believe this website will help you meet your compliance obligations with the least amount of effort and greatest amount of understanding. Visit www.bomcheck.net and view the free webcast on the right hand side of the screen.

Important Information on the Medical Device User Fee Rates for FY2009
The above links to the FDA website.

FDA Changes in Firm Registration and Device Listings
Neal Dunning provides updated (Sept 2008) information regarding registration and device listing changes.

DTA Forum on Dental Branch Activities

This May 22 one-day program in Gaithersburg, MD included:

• 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 & Radiological Health

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

DTA Wins IAF Support to Form New IAF Working Group for ISO 13485 GeMDCAS

Grant Ramaley announced that the DTA had a very successful IAF Meeting. 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.

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. Read more...

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. 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.

DSA Consultants: DSA is a full-service consulting firm, specializing in areas of Regulatory Affairs, Quality Control, and Quality Assurance for Drugs, Medical Devices, Natural Health Products, and Cosmetics. DSA handles all submissions to Health Canada and compliance with the Canadian Food and Drugs Act. Offering reduced rates for DTA Members.

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.

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 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