FDA Title 21, Chapter 1, Subchapter H - Medical Devices, Part 820 Quality System Regulation
All dental laboratories especially those that perform a regulated activity, have a Quality Management System and comply with FDA's Title 21, Chapter I, Subchapter H – Medical Devices, Part 820 Quality Management System Regulation and align with ISO 13485. 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.
The complexity of the Quality Management System and applicable components of FDA's Quality Management System Regulation (QMSR) 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 QMSR 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.
Premarket Notification FDA 510(k)
Before commercially distributing a medical device in the United States, a manufacturer must determine whether the device requires FDA premarket notification, commonly referred to as a 510(k).
Determining whether a 510(k) is required and preparing the submission when necessary can be a complex process. An incomplete or inadequate submission may result in additional FDA questions and delays in bringing the device to market. Experienced regulatory guidance can help manufacturers determine the appropriate regulatory pathway and prepare the documentation needed to support a 510(k) submission.
Most Class I devices and some Class II devices are exempt from 510(k) requirements, subject to certain limitations. However, a 510(k) exemption does not necessarily exempt a manufacturer from other applicable FDA regulatory requirements. Device classification and exemption status should be evaluated carefully before a product is commercially distributed.
Verification of FDA Regulatory Status
When selecting, manufacturing, or distributing a medical device, it is important to verify the device's FDA regulatory status and determine whether FDA clearance or another type of premarket authorization is required.
For devices subject to Premarket Notification 510(k), FDA's public 510(k) database can be used to verify whether the device has received FDA clearance and to review information such as the applicant, device name, 510(k) number, decision date, and applicable product code.
As part of regulatory due diligence, dental laboratories should verify that devices and products subject to FDA premarket requirements have the appropriate authorization for their intended use. Documentation of this verification should be maintained as part of the laboratory's regulatory and quality records, as applicable.
Being prepared is especially important when facing an FDA inspection. Having regulatory documentation organized and readily available can help demonstrate your compliance efforts and avoid having to research a product's regulatory status while an FDA investigator is onsite.
FDA's Quality Management System Regulation (QMSR) incorporates ISO 13485:2016 into the requirements medical device manufacturers must follow, along with additional FDA-specific requirements.
Three examples for dental laboratories as far as the incorporation of ISO 13485 are:
“Management Representative” → broader top-management responsibility. Under the former Part 820, §820.20 specifically required management with executive responsibility to appoint a management representative with defined quality-system authority and responsibility. ISO 13485:2016 also uses the term management representative, so this particular term does not disappear as a result of QMSR. The responsibilities and structure, however, should be reviewed against ISO 13485 and FDA's supplemental requirements.
“Device Master Record (DMR)” → “Medical Device File.” The former §820.181 required manufacturers to maintain a Device Master Record containing or referring to device specifications, production specifications, quality assurance procedures, packaging/labeling specifications, and installation/servicing procedures. ISO 13485:2016 uses the concept of a medical device file. Under QMSR, FDA specifically addresses certain records that were formerly associated with the DMR through the ISO 13485 framework and FDA's supplemental record requirements.
Another good example is “Design History File (DHF).” The former Part 820 specifically used the term DHF. ISO 13485 does not organize design and development documentation under that same FDA-defined “DHF” terminology; instead, it requires design and development files and records demonstrating conformity with design and development requirements.
For dental laboratories subject to FDA's quality management system requirements, this means taking a fresh look at the Quality Management System to determine whether existing policies, procedures, records, and processes meet the current requirements. Simply having a Quality Manual or an established quality system does not necessarily mean that the laboratory is fully aligned with the QMSR.
The extent of the changes needed will vary from one laboratory to another depending on its existing Quality Management System, the devices it manufactures, and its operations.
SafeLink can help evaluate your current Quality Management System, identify gaps, and guide you through the changes necessary to address FDA's current QMSR requirements.
No. FDA does not require a medical device manufacturer to obtain an ISO 13485:2016 Certificate of Conformance, and FDA will not issue such a certificate as the result of an FDA inspection.
Instead, FDA investigators will evaluate whether the manufacturer is complying with FDA's Quality Management System Regulation (QMSR), which incorporates ISO 13485:2016 by reference along with additional FDA-specific requirements. Having an ISO 13485 certificate does not automatically demonstrate compliance with the QMSR, nor does it exempt a manufacturer from an FDA inspection.
The important question is not whether your organization is ISO 13485 certified, but whether your Quality Management System is properly established, implemented, documented, and maintained to meet the applicable QMSR requirements.
A Quality Management System (QMS) is the framework a medical device manufacturer uses to establish and maintain the processes necessary to consistently produce devices that are safe, effective, and meet applicable regulatory requirements.
FDA's Quality Management System Regulation (QMSR), effective February 2, 2026, incorporates ISO 13485:2016 by reference and includes additional FDA-specific requirements. For dental laboratories subject to these requirements, the QMS must be appropriate for the devices manufactured and the activities performed by the laboratory.
A compliant QMS is more than a Quality Manual or collection of written procedures. The laboratory must implement and maintain its quality processes and be able to demonstrate through appropriate documentation and records that those processes are being followed.
If your Quality Management System was developed under FDA's former Quality System Regulation, it should be evaluated to determine what changes may be necessary to meet the current QMSR requirements.
A well-designed Quality Management System (QMS) is more than a regulatory requirement. It can help a dental laboratory establish consistent processes, improve product quality, reduce errors and rework, strengthen documentation and accountability, and identify opportunities for continual improvement. An effective QMS can also help your laboratory be better prepared for customer audits and FDA inspections
It depends on the products that you are manufacturing.
All businesses, including 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. In dentistry that could include Sleep Apnea Devices, Snoring Devices, TMJ splints, and in certain situations in-house milling of customized implant abutments.
• Repackaging or Relabeling of a medical device
• Importing finished appliances from an Offshore establishment.
• Foreign manufacturers, or distributors, including foreign dental laboratories.
U.S. Domestic dental laboratories that do not perform a regulated activity 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 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. Learn more about FDA registration.
Some of the business activities that can trigger registration with FDA are:
Initial Importer - Any importer who furthers the marketing of a device from a foreign manufacturer to the person who makes final delivery or sale of the device to the ultimate consumer or user, but does not repackage, or otherwise change the container, wrapper, or labeling of the device or device package. The initial importer must have a physical address in the United States staffed by individuals responsible for ensuring the compliance of imported devices with all applicable FDA laws and regulations.
Contract Manufacturer - Manufactures a finished device to another establishment's specifications.
Manufacturer - Makes by chemical, physical, biological, or other procedures, any article that meets the definition of "device" in Section 201(h) of the Federal Food, Drug, and Cosmetic (FD&C) Act.
Repackager - Packages finished devices from bulk or repackages devices made by a manufacturer into different containers (excluding shipping containers).
Relabeler - Changes the content of the labeling from that supplied from the original manufacturer for distribution under the establishment's own name. A relabeler does not include establishments that do not change the original labeling but merely add their own name.
Remanufacturer - Any person who processes, conditions, renovates, repackages, restores, or does any other act to a finished device that significantly changes the finished device's performance or safety specifications, or intended use.
Specification Developer - Develops specifications for a device that is distributed under the establishment's own name but performs no manufacturing. This includes establishments that, in addition to developing specifications, also arrange for the manufacturing of devices labeled with another establishment’s name by a contract manufacturer.
Foreign Exporter - Exports or offers for export to the United States (U.S.), a device manufactured, prepared, propagated, compounded, or processed in a foreign country, including devices originally manufactured in the United States. A foreign exporter must have an establishment address outside the U.S.
U. S. manufacturer of export only devices - Manufactures medical devices that are not sold in the U.S. and are manufactured solely for export to foreign countries.
Dental laboratories that mill certain customized implant abutments in-house should be aware that FDA requirements applicable to these devices and their manufacture have changed. A laboratory should not assume that manufacturing a patient-specific abutment from a cleared material or component automatically means that its activities are covered by the material or component manufacturer's FDA clearance.
The regulatory requirements can depend on the device being manufactured, its intended use, the manufacturing process, and the FDA clearance or other authorization associated with the product or system. Laboratories performing in-house milling of customized implant abutments should evaluate their activities to determine whether FDA establishment registration, device listing, premarket notification [510(k)], Quality Management System Regulation (QMSR), or other requirements apply.
Before adding customized implant abutment milling—or continuing an existing process—make sure you understand your laboratory's regulatory responsibilities. SafeLink can assist in evaluating your manufacturing activities and determining the FDA requirements that may apply
Knowing who you are doing business with is an important part of an effective Quality Management System. Manufacturers should establish processes for evaluating and selecting suppliers and subcontractors based on their ability to provide products or services that meet specified requirements. The level of evaluation and oversight should be appropriate to the product or service being provided and the potential effect it may have on the finished medical device.
An effective Quality Management System requires involvement throughout the organization, beginning with top management. Top management is responsible for providing leadership and ensuring that the QMS is established, implemented, maintained, and supported with appropriate resources.
Quality Management Representative or Management Representative
ISO 13485:2016 requires top management to appoint a member of management as the Management Representative. This individual has responsibility and authority for ensuring that the processes needed for the Quality Management System are documented, reporting to top management on the effectiveness of the QMS and opportunities for improvement, and promoting awareness of applicable regulatory and quality requirements throughout the organization.
The Management Representative should have the authority and organizational support necessary to fulfill these responsibilities but does not manage the QMS alone. Quality is a shared responsibility involving management and employees whose activities can affect product quality and regulatory compliance.
Top Management
Top 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 top 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.
Quality Management Team
A Quality Management System works best when quality is not the responsibility of just one person. A Quality Team brings together individuals from different areas of the organization to help integrate quality requirements into everyday operations.
The Quality Team can provide practical input on processes, identify problems and opportunities for improvement, assist with corrective actions, review quality data, support internal audits and management reviews, and help communicate quality expectations throughout the organization.
The size and structure of the Quality Team should fit the organization. In a smaller business, the team may consist of only a few key individuals who wear multiple hats. In a larger organization, representatives from management, production, purchasing, customer service, regulatory, and other functions may participate.
Most importantly, the Quality Team helps create a culture in which quality is part of everyone's job and not simply the responsibility of the Management Representative.
Auditing is a key component in the measurement of the effectiveness and performance of a quality management system.
Auditing can be performed by trained and qualified employees 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.”
FDA requires internal quality audits to be conducted at planned intervals appropriate to your Quality Management System, per the requirements incorporated by FDA’s Quality Management System Regulation (QMSR). Many manufacturers continue to audit at least annually as a practical baseline, though the current regulation doesn’t set that specific minimum the way the former Part 820 did. Audits should still assure that your system not only complies with quality management system requirements, but that the audits determine the effectiveness of the quality management 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 Management System can produce positive results not only to your bottom-line but to your customer satisfaction rating. If you have been implementing a quality management 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.
Corrective and Preventive Action (CAPA) and Root Cause Analysis
Problems, complaints, nonconformities, audit findings, and other quality data can provide valuable information about how well your Quality Management System is working. An effective CAPA process helps identify significant or recurring issues, investigate their underlying causes, and determine what actions are necessary to correct problems and prevent their recurrence. Root Cause Analysis is an important part of this process because correcting the immediate problem without understanding why it happened may allow it to happen again.
Equipment Management
Equipment used to manufacture, inspect, measure, or test a product must be capable of consistently performing as intended. An effective equipment management program addresses appropriate maintenance, inspection, calibration, and other controls based on the equipment and how it is used. Equipment records can also reveal recurring problems, unexpected failures, or trends that may affect product quality and provide opportunities for improvement.
Internal Auditing
An internal audit is one of the most valuable tools for evaluating whether your Quality Management System is working as intended. Rather than waiting for an FDA investigator or customer auditor to identify a problem, internal audits provide an opportunity to evaluate your own processes, identify gaps or weaknesses, and take corrective action. Effective internal auditing looks beyond whether procedures exist. It evaluates whether they are being followed and whether the QMS is effectively implemented and maintained.
Internal audits must be conducted at planned intervals established by the organization. The audit schedule should consider the importance and status of the processes being audited, as well as findings from previous audits. An important change to inspection guidance that was effective February 2, 2026 is that FDA investigators may now review internal quality audit reports during an inspection. This makes it more important than ever to ensure that internal audits are meaningful, properly documented, and used to identify and address opportunities for improvement within the Quality Management System.
Who Audits?
Internal audits may be performed by qualified personnel within the organization or by a qualified outside auditor. Auditors should have the appropriate knowledge and competence to evaluate the processes being audited and must maintain objectivity and impartiality throughout the audit process. Auditors should not audit their own work, so smaller organizations may find that using an experienced independent auditor provides the objectivity and expertise needed for an effective evaluation of the QMS.
Preparing Your Audit and Audit Schedule
An effective internal audit begins with a plan. Your audit program should identify the areas and processes of the Quality Management System to be evaluated and establish a schedule for conducting those audits at planned intervals. The schedule should consider the importance and status of each process, changes that may have occurred, quality concerns or trends, and the results of previous audits.
Before an audit begins, establish its scope and objectives, identify the processes and records to be reviewed, and select a qualified auditor who can remain objective and impartial. The audit schedule should be documented and maintained as part of the QMS.
An outside auditor can provide an independent and objective evaluation of your Quality Management System. An experienced auditor may identify gaps, inconsistencies, or opportunities for improvement that can be difficult to recognize when working within the system every day. Using an outside auditor can be particularly beneficial for smaller organizations where employees responsible for QMS activities may not be sufficiently independent to audit their own work.
A well-planned internal audit should do more than confirm that procedures exist. It should help determine whether those procedures are being followed, whether the QMS is effectively implemented and maintained, and where improvements may be needed.
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SafeLink Consulting is a premier advisor in health & safety programs, environmental controls, quality management systems, and privacy practices, with over 30 years of experience supporting businesses nationwide. We partner with dental laboratories, practices and groups to deliver integrated risk & compliance across OSHA, EPA, Environmental Controls, CDC Infection Control, FDA, and HIPAA serving as a single, trusted partner.
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.
Lab Owner Minnesota
When investigating our lab's 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. 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.
Lab Owner North Carolina