What's All This About FDA?
Beginning this month and going forward each month, the subject covered in Risky Business will alternate between OSHA (health and safety issues) and FDA (quality system requirements). This month compliance with the Food and Drug Administration's (FDA) Quality System/Good Manufacturing Practices (QS/GMP) is the topic.
Does FDA regulate dental laboratories and who has to comply in the dental laboratory industry?
Yes, FDA regulates dental laboratories. All dental laboratories who manufacture dental appliances, subcontract to other dental laboratories - domestic or foreign, or import dental appliances must comply with Title 21, Chapter I, Subchapter H - Medical Devices, Part 820 Quality System Regulation. You can find this on the FDA's Web site at www.fda.gov. The exact web address for this document is http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CF.... This document is only 23 pages in length so print it out and read it. It's an overview document so you must interpret what you need to do to meet the requirements. NADL has brought DAMAS to the U.S. to help you with compliance so help is available.
The intention of the coming articles in Risky Business is to explain to you how to comply with the FDA's QS/GMPs.
Does the size of the laboratory make a difference in the compliance requirements?
No. Whether you're a two-technician laboratory or a 60-technician laboratory, you are subject to the same requirements. A smaller laboratory will have a much simpler quality system, but it still must contain all of the components of the GMPs. Larger dental laboratories find it much more complex to comply because they must rely on so many individuals in their laboratory to do their part in the quality system.
What are some of the components of a quality system?
The regulation requires:
* That various specifications and controls be established for devices.
* That devices be designed under a quality system to meet these specifications.
* That devices be manufactured under a quality system.
* That finished devices meet these specifications.
* That devices be correctly installed, checked and serviced.
* That quality data be analyzed to identify and correct quality problems.
* That complaints be processed.
Thus, the QS regulation helps assure that medical devices are safe and effective for their intended use. The FDA monitors device problem data and inspects the operations and records of device developers and manufacturers to determine compliance with the GMP requirements in the QS regulation. Many dental laboratories have been inspected by the FDA over the past several years and those numbers seem to be increasing.
Do I have to register my dental laboratory with FDA?
All dental laboratories do not have to register with FDA. However, there are a number of factors that would trigger registration with FDA. Some of them are:
* The manufacture of Class II Medical Devices such as Sleep Apnea Devices, Snoring Devices, and TMJ splints.
* Repackaging or Relabeling of a medical device.
* Importing finished appliances from an offshore dental laboratory.
* Foreign dental laboratories.
To review FDA's registration requirements or to register go to http://www.fda.gov/cdrh/registration/furls.html.
How can a Quality System benefit my business?
Perhaps your immediate reaction to more government intervention is negative, however, our clients who have formalized their quality system see it now as a good business practice that can improve the quality of their product and result in fewer internal reworks and external remakes thus saving them substantial amounts of money. So, it is hoped that you will view it from that perspective and move forward to improve your business through your quality system.
DAMAS is a quality system that provides a third-party certification and available through the NADL. If you're familiar with DAMAS, then you know that this is one method for formalizing your quality system. The information that is going to be provided in Risky Business will assist you in developing and implementing a quality system and meeting the requirements of FDA and DAMAS.
How do I Get Started on my quality system?
* Print out the FDA Quality System Regulation and retain it in a binder. Review it and begin to understand what you need to do to develop a written program.
* If you want to become DAMAS certified go to the NADL Web site (www.nadl.org) and submit your information - fee required. You can also contact SafeLink for assistance.
* Appoint a management representative to oversee the quality system. Document this appointment and provide the management representative with a list of his or her responsibilities. Subpart B, Section 820.20 of the FDA Quality System Regulation outlines these responsibilities.
* A large dental laboratory with a management team will appoint a quality team to work with the management representative. Meet with the quality team to outline their responsibilities. Have a kickoff meeting with all employees to explain what the quality system is all about. The quality team typically is comprised of those individuals in charge of production, purchasing, training, equipment maintenance, facility maintenance, customer service, IT and human resources.
* Determine if you need to register with FDA and if so, get registered.
The Risky Business column in April, June, August, October, and December will provide specific information on purchasing controls, traceability of materials, training, maintenance and calibration of equipment, cleanliness, labeling and packaging, complaints/non-conforming product, corrective actions, internal audits, and management review.
Quality Tips for the Month:
If you are subcontracting out any completed appliances, you must indicate on the invoice or label to the dental client that you are the distributor not the manufacturer. You could state "Distributed by (your laboratory's name)" or "Manufactured for (your laboratory's name)". We also recommend that you indicate the country of origin if it wasn't made in the U.S. Also, if you are repackaging an appliance made by another laboratory, domestic or foreign, and putting your name on it, then you must register with FDA as a repackager/relabeler. This does not apply to components such as copings or partial frameworks that you may outsource but then complete the appliance in your laboratory.
Request from all subcontractors a written statement of assurance that they are complying with FDA's Quality System Regulation. Update that statement regularly.
Safety Tip for the Month: If you are located in Minnesota, Nevada, Washington or Hawaii, you must post your completed Form 300A, the Occupational Injury and Illness Summary, from Feb. 1 to April 30.