As you may be aware, the Food and Drug Administration announced a couple of years ago that it would be making changes to the Quality System Regulation (CFR Title 21 Part 820). This regulation requires that all medical device manufacturers implement an appropriate Quality System and current Good Manufacturing Practices The current requirements have been in place since 1996.
ISO 13485 is an internationally recognized set of quality system specifications developed by the International Organization for Standardization specifically for medical device developers and manufacturers. These specifications have likewise been around since 1996.
While FDA Part 820 is mandatory, ISO13485 is a voluntary system to which certification may be attained, similar to DAMAS (Dental Laboratory Manufacturers Audit System) certification. To comply with Part 820, dental laboratories that are engaging in manufacturing activities, as defined by FDA, must implement a quality system that meets the requirements of the QSR. The QSR requires that the facility have documented good manufacturing procedures in place appropriate to the activities being performed whether it be manufacturing patient specific dentist prescribed devices, manufacturing Class I or II medical devices, importing devices, or repackaging and relabeling devices. This could be accomplished by simply following the QSR requirements or conforming to the specifications in ISO13485 or DAMAS. Both systems could be audited by FDA for compliance purposes and many of our clients who were DAMAS certified went through FDA audits very successfully. Certification to either of these specifications could be used for marketing purposes. Facilities cannot market that they are FDA compliant, only conforming to FDA.
Many regulatory bodies have over the years embraced ISO13485 as the standard for a quality system. FDA only recognized conformity to the QSR. This made it a little more difficult for international trade as foreign facilities have to conform to different sets of requirements. Harmonizing with the ISO standard as the QSR is intended to make international trade easier. Facilities who attain ISO13485 certification will most likely have less invasive inspections from FDA as they will have already been through an extensive audit program by the registrars for ISO. This may sound ominous for dental laboratories, but it isn’t, as FDA should not require ISO registration, only conformance with the specifications. This the good news since registration to ISO13485 is an expensive proposition, especially for small businesses.
So, what does all of this mean for dental labs. For the time being it doesn’t change anything. If you have a quality system in place whether it be Part 820 conforming, ISO13485 conforming, or DAMAS conforming you are in good shape. Please understand that the DAMAS specifications were based on FDA Part 820 and while the DAMAS program is no longer supported in the U.S., those labs that were DAMAS certified do not have to create a whole new Quality System. As FDA goes through this change process, an implementation window of time will be given to attain conformance to the new Quality Manufacturing System standards which will be primarily ensuring that the quality system documentation is conforming.
Our team at SafeLink consulting is here to help guide you through this transition. Our consultants have already been working with ISO13485 and can ensure that your quality system documentation will be ready for the future.
FDA inspections are on the rise for dental labs - learn more.
Have questions about your dental lab quality system or need FDA compliance assistance? SafeLink Consulting can assist your business with developing a Quality System and Good Manufacturing Practices - GMP for medical devices manufacturers including the dental lab, workplace health & safety training, infection control training and HIPAA training online, plus more.
Learn more about FDA Dental Regulations
Learn more about what SafeLink Consulting can do to help your business with compliance services, including safety compliance, to meet OSHA training requirements and quality system consulting to meet FDA compliance. SafeLink Consulting assists businesses with workplace safety training, infection control training, HIPAA training online, quality systems, assessments, audits, due diligence, and more.
Industries include:
Dentistry compliance - assisting the dental practice with meeting requirements for OSHA, HIPAA, EPA, and CDC guidelines, patient safety and employee health & safety
Dental Laboratory compliance - assisting the dental lab with meeting requirements for OSHA, FDA, and CDC guidelines, employee health & safety, plus FDA requirements for lab manufacturing custom implant abutment /gmp for medical device manufacturers
Medical Device Manufacturers compliance - assisting with meeting OSHA compliance & FDA requirements, GMP - good manufacturing practices
General Industry compliance - assisting with OSHA compliance and FDA compliance as it pertains to the specific business
Beverage Industry compliance - assisting beverage businesses such as the craft brewery, winery, cidery, distillery, vintner with meeting OSHA compliance, health & safety,FDA requirements / CGMP - Current Good Manufacturing Practices, and FMSA - Food Safety Modernization Act (FMSA).
