FDA Title 21, Chapter 1, Subchapter H - Medical Devices, Part 820 Quality System Regulation
All dental laboratories who manufacture dental appliances, subcontract to other dental laboratories – domestic or foreign, or import dental appliances must have a Quality System and comply with FDA's Title 21, Chapter I, Subchapter H – Medical Devices, Part 820 Quality System Regulation. You can find this on the FDA’s website. This is an overview document so you must interpret what is needed to meet the requirements.
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The Basics of FDA's Title 21 Course
The complexity of the Quality System and applicable components of FDA's Quality System Regulation (QSR) depend on the lab's business model. Part of the development process is to assess how FDA's regulations apply to the types of devices manufactured in your lab or manufactured for you by others. This requires knowledge of not only the QSR but other FDA regulations that pertain to the classified devices.
FDA 510(k) Documentation
FDA is responsible for protecting the public health. It regulates the use of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics, and products that emit radiation. How do you know whether or not your product requires clearance by FDA? If it does, then do you need FDA 510 (k) submission guidance?
There are some determinations that must be made depending on the classification of the device. FDA classifies medical devices into three classes. Class I devices are the least regulated and Class III the most regulated. The following will review some of the considerations that need to be taken prior to placing a regulated device on the market.
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3 Ways Your Product Offerings Can Trigger FDA's Attention
Premarket Notification FDA 510(k)
Prior to commercial distribution of a device, it must be determined if the device requires a Premarket Notification 510(k). A 510(k) must demonstrate that the device is substantially equivalent to one legally in commercial distribution in the U.S. The device cannot be commercially distributed until a letter of substantial equivalence is received from FDA authorizing its distribution. This is when you will need 510k submission guidance. The process is lengthy and it’s critical that it be handled by experts. An incorrect or incomplete submission to FDA can delay the distribution of your product.
There are some exemptions from Premarket Notification 510(k) submission. Most Class I devices and some Class II devices are exempt from the Premarket Notification 510(k) submission. A list of exempt devices is located at FDA.gov - Medical Device Exemptions 510(k) and GMP Requirements.
Verification of Clearance
There are steps you should take to verify clearance of a classified product if you are a manufacturer or distributor of a classified device. The FDA website provides this information, however, you must know the name of the initial developer of the product and 510(k) submitter. The link to begin this search in FDA’s database can be found at FDA.gov – 510(k) Premarket Notification . A part of due diligence when selecting a classified and regulated product for use is to verify that the product has been cleared by FDA for the intended use. In an FDA inspection, an organization may have to show the FDA investigator this documentation. Much better to have done this prior to an FDA visit than during an FDA visit. There’s enough stress in an investigation so make your life easier by being prepared.
The FDA Quality System 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 Good Manufacturing Practices (GMP) requirements in the Quality System regulation. Many dental laboratories have been inspected by the FDA over the past several years and those numbers seem to be increasing.
Good Manufacturing Practices (GMP)
Your Quality System and Good Manufacturing Practices (GMP) are a critical part of establishing controls to provide a consistent product or service. According to FDA, (Current Good Manufacturing Practices (CMGP) also known as Good Manufacturing Practices (GMP) provide guidelines for manufacturing, testing, and quality assurance to ensure that a product is safe for human or animal consumption or use. Manufacturers are responsible for complying with GMPs. Manufacturers must establish and follow quality systems to help ensure that their products consistently meet applicable requirements and specifications. The quality systems for FDA-regulated products (food, drugs, biologics, and devices) are known as current good manufacturing practices (CGMP’s). Quality System (QS) Regulation / Medical Device Good Manufacturing Practices
Quality System Components
Under this FDA regulation, a dental laboratory must establish a Quality System/Good Manufacturing Practices (QS/GMPs).
The regulation requires that:
The components of QS/GMP’s include:
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 (Dental Manufacturers Audit System) is a Quality System that provides a third-party certification and is owned by NADL (National Association of Dental Laboratories). If you’re familiar with DAMAS, then you know that this is one method for formalizing your Quality System.
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Improving Your Quality Output
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:
U.S. Domestic dental laboratories that do not produce or distribute medical devices are exempt from FDA registration. Dental labs and other businesses that produce or distribute medical devices in the United States must register with FDA each year. This process is known as establishment registration. FDA refers to manufacturers and others registering with FDA as an “establishment”. The business must register immediately upon producing or distributing these items and then renew their registration by December 31st each year thereafter. FDA is authorized by the Congress to collect an annual establishment registration fee. This registration process is accomplished electronically through the FDA’s website at www.fda.gov. Get assistance with FDA registration.
Some of the business activities that can trigger registration with FDA are:
If you ship direct to a foreign dental laboratory and receive your appliances direct from the foreign dental lab, then you must register as the Initial Importer. If you go through a corporation in the US that is receiving your work, shipping it to the foreign lab, receives the work from the foreign lab, and then ships it to you, then you wouldn’t register with FDA. You want to be sure, however, that the corporation in the US is registered with FDA.
If your business receives finished devices direct from a foreign manufacturer, then FDA registration is required and it places you in FDA’s inventory for an inspection.
If your business uses the alternative to the above by purchasing imported devices from a U.S. broker, then ensure that the U.S. Broker is properly registered with FDA.
Your business is considered a contract manufacturer if you manufacture a device for the specifications developer. Some examples are sleep apnea devices, snore guards, and custom implant abutments.
Manufacturer means any person who designs, manufactures, fabricates, assembles, or processes a finished device. If your dental laboratory manufactures Class I or Class II devices, such as, sleep apnea, anti-snoring devices, or TMJ splints, then you must register with FDA. If you or your business owns a 510(k), then you are considered a manufacturer and must register with FDA. Foreign dental labs manufacturing dental appliances for shipment into the U.S. must be registered with FDA. Ask your subcontractor for evidence of this registration. Many of the foreign dental laboratories are also ISO registered. A copy of that registration is good to have on hand as one of the steps in qualifying your subcontractor, but it is not a substitute for the FDA registration.
Repackaging / Relabeling
If you import dental devices such as finished crowns and dentures and upon receipt remove them from the foreign lab packaging and place them into your packaging with your name, then you must register as a repackager/relabeler.
If you take an order from a dental client for a sleep apnea device or snore guard but have another dental lab manufacture the device for you and upon receipt you place the item into your packaging with your name on it, then you must register as a repackager/relabeler.
A specifications developer designs and develops specifications for a device but may not necessarily manufacture the device.
Qualify your Subcontractors and Suppliers
It is important that you know who you are doing business with, therefore, an important element of a quality system involves supplier and subcontractor evaluation.
Patient contact materials must be cleared by the FDA for use in the human body. Therefore, when qualifying your suppliers of materials, you should have access to the FDA registration for those materials. A part of your evaluation process is to confirm that they have a Quality System and meet any other federal or state requirements that pertain to their business model.
In your evaluation of the subcontractor, ensure that you ask the right questions and even go to the extent of visiting their facility to conduct a survey of their Quality System. Request from all subcontractors a written statement of assurance that they are complying with FDA’s Quality System Regulation.
If you are subcontracting 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 lab name)” or “Manufactured for (your lab name)”. U.S. Customs requires disclosure of country of origin to the end user.
In-house CAD/CAM milling of customized implant abutments requires that there is a 510(k) for the system and that it allows dental labs to mill the abutments.
Alternative is to purchase custom abutments from manufacturers who are meeting the FDA’s clearance and registration requirements. Perform your due diligence to ensure that they meet all regulatory requirements.
With 3D printing (additive manufacturing) growing rapidly throughout the manufacture of medical devices, business owners not only have to determine the type of 3D printing dental equipment to purchase but also the FDA dental regulations that apply to their business. Printing of models has been around for several years, but now this technology can print parts and even complete restorations.
The use of CAD/CAM technology in the manufacture of surgical guides for guided implant surgery requires FDA registration. There have been FDA inspections of dental labs where FDA has required this.
FDA determines that dental surgical guides for dental implants manufactured with the use of CAD/CAM are regulated as Class I medical devices. They are 510(k) exempt; however, they do require FDA registration and listing by the manufacturer.
Here are some scenarios so you can determine if your business meets this requirement when manufacturing surgical guides for guided surgery:
If you attempt to do dental surgical guide FDA registration on your own, then use the listing code of NDP. Get assistance.
Watch Intro video:
Read more about these types of registrations and how to accomplish registration: Who Must Register, List and Pay the Fee
Review FDA’s registration requirements or to register: Device Registration and Listing
Learn more by taking this online course: How to Navigate Public Info on FDA's Website
These individuals help manage your quality system and evaluate its effectiveness.
Quality Management Representative
Your business must appoint a Management Representative to manage your Quality System. Document this appointment and provide the Management Representative with a list of his/her responsibilities. Subpart B, Section 820.20 of the FDA Quality System Regulation outlines these responsibilities. Get training for your Management Rep.
It takes the right person for this role. The person who initially helps develop the quality management system may not be the correct person in this position to take the quality system to another level. If your quality system is just documentation, then the Management Representative must have the skills to move the organization’s quality system into a position of improving your business which includes the relationship with your customers. It's important to develop a job description for this role and find the right person in your organization for the position.
Senior management should recognize the positive benefits derived from reduction in failure costs, i.e. customer complaints, remakes, internal reworks, material waste, etc. The Management Rep should collect this data and present this feedback regularly to senior management. The Management Rep should set up regular meetings to review the information with top management. The annual Management Review Meeting, which is required by most quality systems, will be the opportunity to perform a thorough review of the effectiveness of the quality system.
The Management Rep must continually perform organizational problem-solving exercises to improve the business' quality management system plan. Presenting the savings to senior management will show how they are linked to quality. Having a quality team to work with will help attribute the success to the entire team to stay on track.
Senior management must support the quality management system for it to be effective. They must acknowledge that it provides value to the organization. The culture of an organization is primarily driven by senior management and especially the CEO. The quality system must be positioned to better the business.
The goals and strategic direction of the organization must stay current. If not, then discussion with top management is important because without these goals and strategic direction, you have nothing with which to align your quality management system. The quality management system should be contributing directly to achieving the organization’s vision, mission and strategic goals.
Your Quality Policy provides the basis for evaluation and effectiveness of your quality management system.
Quality Management Team
The Quality System Regulation requires a review of the suitability and effectiveness of the quality system to meet the organization’s quality objectives. This usually takes place at the annual Management Review Meeting which is required under FDA’s Part 820.20(c) , DAMAS 4.15.2 and ISO13485 5.6.1.
The Management Review Meeting must occur at a minimum annually, however, it may occur more frequently. The size of your business will help determine the need for meetings. The frequency of audits and any significant problems that need to be addressed will require a meeting. Major changes in your business such as new technology, your business model, quality concepts, market strategies, and resources can also affect the frequency of these meetings.
The members should be management with executive responsibility which would include those senior employees who have authority to establish or make changes to the quality policy and quality system. Remember that the purpose of this meeting is to help you evaluate the effectiveness of your quality system so the more detail you include in the minutes the more it will help the Management Representative to document the improvements committed to by management.
Top management must ensure that the quality policy is appropriate to the purpose of the organization and that the quality management system is effective to provide a framework for establishing and reviewing quality objectives. Use your Management Review Meeting to establish measurable goals for continuous improvement.
Auditing can be performed by trained and qualified employees of the lab or by an outside auditing firm. A quality audit is a formal, planned check of all elements of the quality system. FDA states in its inspection guidelines that, “without an effective quality audit function the quality system is incomplete and there is no assurance the manufacturer is consistently in a state-of-control”.
Both FDA and DAMAS require, at a minimum, an annual audit. DAMAS requires that the lab audit the management system to verify that the manufacturing processes comply with planned arrangements.
FDA states in Section 820.22 of the Quality System Regulation that you establish procedures for quality audits and conduct the audits to assure that your system not only complies with quality system requirements, but that the audits determine the effectiveness of the quality system.
In order to address product quality issues, the processes audited must have a direct impact on actual product quality, such as internal procedures and processes and customer-reported failures.
An effective Quality System, such as DAMAS, can produce positive results not only to your bottom-line but to your customer satisfaction rating. If you have been implementing a quality system by using the components reviewed here, then you should already be bringing a positive return to your bottom-line, however, there’s always room for improvement.
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Improving Your Quality Output
Key components of improvement include:
Corrective And Preventive Action (CAPA)
One of the most important components of a quality system is the corrective action process. This is the discovery procedure that you should have developed for investigation of root cause for nonconforming product (remakes and internal reworks). Take a good look at how you are tracking the root cause of remakes and internal reworks so that you’re taking the type of corrective action that will produce positive results. Remember the investigation for root cause includes worker competency, materials, and equipment.
Equipment Management System
Another component of the quality system that can produce positive results is the equipment management system. In an issue of Quality Progress, there’s an article titled “Take a Bite Out of Inefficiency” and it tells about a dental office in Pennsylvania that used ISO 9001:2000 to construct a comprehensive equipment management system. Apparently this dental office had considerable down time due to poorly maintained equipment. By implementing some of the practices of ISO 9001:2000, they began tracking the installation, maintenance, and repair of critical equipment. This process reduced repair visits dramatically and avoided unnecessary downtime.
This is exactly what you should be doing in your business to ensure that all equipment is available when you need it and that it is operating efficiently. An equipment management system includes:
Properly maintained equipment can help eliminate downtime that could affect delivery of your product.
Internal Auditing - Root Cause Analysis
An internal audit is a process of comparing actual operations against the commitments made in your quality system. There must be a written schedule of quality audits. Frequent audits may be conducted if the results of the annual audits indicate serious Quality System Regulation problems.
Your audit system should include a defined objective, an infrastructure, a trained cross-functional team of auditors, and an effective corrective and preventive action system.
Let’s presume that you are measuring internal reworks and find that one certain department has the most internal reworks. The product manufactured by that department also results in the most re-scheduling or delivery complaints. Once you have defined the problem and put together a team to get to the root cause of the problem, then the appropriate actions can be taken to prevent the recurrence of these issues. Reworks cost businesses a lot of money in time, materials, excessive use of equipment, etc.
Your business should improve due to the effectiveness of your Quality System (QS). Business owners should work with their Management Representative to schedule internal audits that will result in continuous improvement and customer satisfaction. Get an ASQ-certified internal auditor.
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Using Your Lab Quality System to Reduce External and Internal Remakes
Individuals conducting the audit must be appropriately trained. Audits should be conducted by individuals not having direct responsibility for matters being audited. For a smaller business, it may mean hiring an independent outside auditor. FDA can cite for a lack of adequate audits if in their inspection they identify serious deficiencies.
Re-audits either by your internal auditor or an external auditor may be required for serious deficiencies.
FDA is prohibited from reviewing results of quality audits. They can ask for the management representative to confirm that audits have been conducted. It is to be noted, however, that if an audit results in the need for corrective action that the corrective action records are viewable by FDA.
Preparing your Audit and Audit Schedule
One method in setting your schedule is to select components of your written quality system and divide them into four different audits. For instance, your audits could be divided as follows:
Effective audits must be properly planned and executed. Developing an audit checklist will ensure that audit planning is conducted and that the auditor knows what questions to ask. A well-designed audit checklist significantly improves the process awareness, audit structure and documentation.
With a well-planned and well-defined checklist, a successful audit is achievable. Remember the first step in auditing is to completely understand the governing requirements such as the FDA Quality System Regulation and applicable third-party certifications, such as, ISO and DAMAS.
After your audit, your final step is to document your audit report in order to communicate the results of the investigation. Provide correct and clear data that will be effective as a management aid in addressing important organizational issues. The audit ends with presentation of this report, however, follow-up and closure actions may be necessary.
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FDA - Auditing 3-Part Series - Basics of Internal Auditing
We appreciate the assistance we’ve received from SafeLink Consulting in helping us to understand the complexities of our regulatory systems. Beyond the effort of creating a comprehensive quality management system is the opportunity to work on overall efficiency within the organization, and the peace of mind that comes with it.
Scott Udell Udell Dental Laboratory, MN
When investigating Drake Precision Dental Laboratory, Inc compliance with the FDA's statutes regarding "Good Manufacturing Practices (GMP)" the question was, How do we effectively comply with the regulations? We had a quality system in place but needed to organize it and formalize it into a system that FDA would recognize. Our choice was DAMAS and we have become certified in those specifications. SafeLink provided consulting during the development of our processes and has conducted External Audits which have provided beneficial to us in continuing to improve our quality system.
Bob Savage Drake Precision Dental Laboratory, NC