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, Neal Dunning, is also a source of information about regulations.

Regulatory Committee E-Newsletter, November 2009

Topics include an update on health care reform, exporting to China, and an update on Universal Accreditation to ISO 13485.

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

Unique Device Identification (UDI)

On February 12, 2009, FDA held a workshop in Gaithersburg, Maryland on Unique Device Identification (UDI). The purpose – outline the progress FDA had made on launching a new system of labeling and identifying medical devices. (All dental products and equipment are considered medical devices.) Dr. Jay Crowley from the FDA’s Center for Devices and Radiological Health (HFZ-500) chaired the workshop.

At that meeting, FDA identified a bar coding system – most likely to be used as the basis for a new UDI program and to be implemented in the US in three years (2012 or 2013). The UDI system can be recognized globally. It remains unclear how many years until the system is adopted worldwide.

A majority of dental products and small equipment will require a bar code on the packaging and not the actual device. Exceptions may include large equipment or devices inserted into a patient – like implants. The bar code identifies manufacturer, type of device and contact information – in the event of recalls or emergency. A second bar code may be required for a shipment’s lot number and date of manufacturing. Companies would pay a fee for their bar code number and to be registered on a national data base. This system should eliminate additional pedigree filings and data storage.

This is just one step in a long process to implement UDI. FDA identifies dental devices as mostly low risk devices and the final group of medical devices to require UDI. FDA announced it was accepting additional comments on UDI until April 16, 2009. To learn more about the FDA Workshop and progress on UDI, go to http://www.fda.gov/cdrh/ocd/udi/ and www.fda.gov/cdrh/meetings/021209workshop. To share additional comments, send comments via email to:

Jay Crowley, Center for Devices and Radiological Health (HFZ–500)
Food and Drug Administration,
1350 Piccard Dr., Rockville, MD 20850
Phone: (240) 276-3400
e-mail: CDRHUDI@fda.hhs.gov

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.

Advena Regulatory Reports (PDFs)

November 2008: 8 pages.

August 2008: includes some information on bar coding of meds and healthcare products in the UK. 6 pages.

July 2008: Neal Dunning says that these regulatory reports can be used to check for updates to changes to standards. ADVENA is well connected with BSI and they regularly post the changes as they happen. The regulatory reports narrow your search to pertinent Medical/Dental related standards.

There are some interesting tidbits in here on some things FDA inspectors and ISO/CE auditors are paying more attention to, including reviewing the FDA MAUDE database to see if your company has any new reports against it. This is not a bad idea to include in your post-market surveillance activities, since some of the most important critics may report to the FDA before they report to you.

May 2008: This 6-page PDF document includes information on environmental issues that effect medical device manufacturers.

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.

August 2008 Update from DTA's Committee on Regulatory Issues
Topics include "Legacy Drugs – New Tactic and Help", and "DTA Appointment to the IAF Multilateral Arrangement Management Committee". Read Grant Ramaley's full update.

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.

Watch for a new update in 2010 on the Pedigree Issue for pharmaceutical based dental products.

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.

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.

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

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