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Understanding and Complying with the FDA May 5, Western States Conference Presented by Bennett Napier, CAE

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  • Understanding and Complying with the FDA May 5, Western States ConferencePresented by Bennett Napier, CAE

  • Federal Regulatory Agencies With Purview over Dental Laboratories

    U.S. Dept. of Labor, Wage and Hour

  • Why are dental laboratories being looked at now?Increase in import tradeAging populationAdditionally focus on cosmetic dentistryIncreased awareness of the dental laboratory industry

  • The amount of dental devices now being imported into the United States is enormous.Bryan BeneschOffice of Compliance, FDA

  • Why is the FDA the oversight agency?The FDA is the federal agency that is responsible for ensuring the safety of materials and Medical Devices.The FDA is responsible for ordering the recall of a medical device if it finds a reasonable probability that it would cause serious adverse health consequences or death.Dental restorations are classified as Medical Devices.

  • Understanding the FDAs ObjectivesFor the most part, the FDAs focus on domestic dental laboratories will center on these areas:(1) Assuring that the materials used are FDA approved.(2) Assuring that sufficient written procedures are in place to comply with the QS/GMP. (3) Compliance with registration requirements.(4) Compliance with re-labeling requirements.

  • Medical DevicesThere are three types of medical devices:Class I common dental restorations, such as crowns, dentures and bridges would be classified here but currently are not classified.Class II sleep apnea/snoring devicesClass III Body appendages (arms, legs) prosthetic devices

  • Import Trade Raises the StakesThe Food and Drug Modernization Act of 1997Section 417: any establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a drug or device imported into the United States must register with the FDA.Effective: February 11, 2002

  • Timeline for FDA activities relative to Dental LaboratoriesIn 2003 FDA released guidance document on: CAD/CAM dental restorations Sleep Apnea devices Class II Devices, Dental Base Metal Alloys for Custom Manufactured Devices In July 2003 a laboratory in Costa Rica was inspected by FDA for QS/GMP

  • From 2004 to Date FDA ActivitiesFDA has inspected at least 4 more laboratories.Inspections are generally for cause which means that someone reported the laboratory and the inspection was not random.Registered and unregistered laboratories have been inspected.

  • REGISTRATIONHow do you determine if your laboratory is required to register with the U.S. Food and Drug Administration?

  • Answer the following questions:(1) Is your laboratory based outside the U.S.? (2) Do you manufacture sleep apnea/snoring appliances? ( 3) Do you outsource any of your work to a foreign laboratory?

  • If you answered yes:A yes answer to any of the previous questions would trigger registration with the FDA.

  • Is your laboratory based outside the U.S.? As noted previously, because of the 1997 Food and Drug Modernization Act all foreign dental laboratories are required to register with the FDA. In addition, foreign establishments must provide the FDA with the name of the U.S. agent representing their establishment. They must also continue to list the devices that they export to the U.S.

  • Do you manufacture sleep apnea/snoring appliances? The FDA classifies sleep apnea and snoring appliances as Class II Medical Devices. All manufacturers of Class II Medical Devices are required to register with the FDA.Registrants must provide a list of the products that they sell to FDA

  • Are you an orthodontic laboratory or do you have an orthodontic department in your laboratory?Some orthodontic appliances are classified as Class II Medical Devices and as such would require your laboratory to register with the FDA as a manufacturer of such devices.Registrants must provide a list of the products that they sell to FDA

  • Do you outsource any of your work to a foreign laboratory? If you outsource anything to a foreign establishment then you must register with the FDA as an initial importer/initial distributor.Under 21 USC 360; 21 CFR 807, the definition of a manufacturer includes repackaging or otherwise changing the container, wrapper or labeling in furtherance of distribution.Registrants must provide a list of the products that they sell to FDA

  • Who is Exempt from Registration?The FDA has the authority to exempt certain entities from registration. The FDA has exempted persons who dispense devices to the ultimate consumer or whose major responsibility is to render a service necessary to provide the customer with a device.This includes domestic dental laboratories under 21 CFR 807.65(I)

  • OutsourcingWhat do you need to know to comply with the FDA guidelines

  • What to do if you outsource to a laboratory outside the U.S.:Register with the FDA as an initial importer.Require an affidavit from the laboratory that you outsource to stating that they only use materials that are FDA approved.Make certain that the laboratory that you outsource to is registered with the FDA.Comply with re-labeling requirements.

  • What are the re-labeling requirements?If a dental restoration was not made by your laboratory then it must be labeled as follows

    manufactured by (insert the name of the foreign laboratory) Or

    distributed by (insert the name of your laboratory)

  • What to do if you outsource to another domestic laboratory?Ask the laboratory if they outsource work to another foreign facility. If they do then require an affidavit from them stating that they and the laboratory that they outsource to are both registered with the FDA.Require an affidavit from the laboratory that you outsource to stating that they comply with QS/GMP and only use materials that are FDA approved.Comply with re-labeling requirements.

  • In essence, you are accountable for ensuring that if youre going to use a foreign firm that it meets all requirements.Harold Wally Pellerite(former) Asst. to the DirectorOffice of Compliance, FDA

  • Documentation assists in ComplianceLabeling/Pass ThroughKnow where its BeenLabel where its GoingIdentify Chain of DistributionMaterial used in device (and oversighting agencies)DeviceMSDS Sheet/Identalloy Stickers (to meet US requirements)State Requirements(i.e. Prop 65 in CA)

  • Quality Systems/Good Manufacturing PracticesWhat is the criteria and how does your laboratory comply?

  • Dental Laboratory Requirements and ResponsibilitiesAll dental laboratories are legally responsible for ensuring compliance with pertinent regulations.The FDA requires that all manufacturers of medical devices establish AND implement a quality system, tailored to the device that is manufactured.This includes dental laboratories, regardless of whether or not you are required to register with the FDA.

  • QS/GMP StandardsDesign ControlsDocument ControlsPurchasing ControlsIdentification/TraceabilityProduction and Process ControlsAcceptance ActivitiesNonconforming Product

    Corrective and Preventive ActionLabeling and Package ControlHandling, Storage, Distribution and InstallationRecordsServicingStatistical Techniques

  • 325 John Knox Rd, L103Tallahassee, FL 32303Toll Free (800) 950-1150Phone (850) 205-5626Fax (850) 222-0053www.nadl.org www.nbccert.orgFor More Information Please Contact:

    Tonight, we will be focusing on the United States Food and Drug Administration (FDA). I will answer the following questions; Why now? Who is affected? What will you have to do to comply?Overwhelmingly the largest contributor for the new attention that dental laboratories are getting from the FDA is due to the increase in import trade.FDA is focusing on the materials and procedures because they both relate to patient safety and long-term health. Class I Medical Devices are usually thought of as more common and do not require FDA testing and study before they are introduced to the U.S. market.Class II Medical Devices, such as sleep apnea appliances and some orthodontic appliances require testing and research by the FDA before they become approved for the market. We will discuss how manufacturing and distributing a Class II device requires registration with the FDA.Class III medical devices.. So I already told you that the number one reason that the FDA is taking a closer look at dental laboratories is the increase in import trade. Additionally, it is because the U.S. enacted some laws to protect its citizens by making imports have to meet FDA guidelines.To give you a quick overview of when and how the FDAs activities began to catch the eye of the staff and leadership at NADL. In 2003 the FDA released three guidance documents relative to Class II Medical Devices. Additionally, in July of 2003 a dental laboratory in Costa Rica was inspected for QS/GMP this laboratory was owned by a laboratory that was based in the U.S. Additionally, between August 1, and December 17, 2003 a lot of other activity took place. Specifically, in August, September and again in December three different shipments containing dental restorations were stopped at port for disclosure requirements (510K). These restorations came from Pakistan, China and Asia. Additionally, two U.S. based laboratories; and ortho lab in Texas and another lab in FL also received warning letters from the FDA on non-compliance with FDAs QS/GMP. Last an Alberta, Canada based dental lab that does work in the U.S. was inspected by the FDA for QS/GMP compliance.

    At the end of 2003 NADL staff begin to actively monitor the FDA activities relative to dental laboratories. Although we have little data to compare it with, it appears that the activity has increased significantly. Between January and the end of July2004, five shipments have been held at port for 510k disclosure requirements. Perhaps more concerning to NADL is that 2 additional U.S. based laboratories, one in N.J. and one in Texas were sighted for inspection by FDA for QS/GMP compliance.

    There are three primary reasons that a dental laboratory would have to register with the FDA: (1) All foreign dental laboratories must register. (2) Domestic laboratories that are initial importers must register; and (3) Domestic laboratories that manufacture Class II Medical Devices (sleep apnea and some orthodontic appliances). Regardless of whether or not your laboratory is required to register with the FDA or not, all dental laboratories fall under the oversight of the FDA and are therefore subject to inspection.Foreign dental laboratories must register so that the FDA can track who is shipping into the U.S. foreign labs are subject to FDA inspection. Domestic labs that import dental prosteses from a foreign laboratory again so that FDA can track both the original manufacturer and materials and products. And labs that produce Class II devices such as sleep apnea/snoring appliances because the design and use of these devices is regulated and strictly enforced by the FDA.To ensure that the FDA is notified of all regulated products imported into the U.S., the importer, or their representative, must file and entry notice and an entry bond with the U.S. Customs Service pending a decision regarding the admissibility of the product. FDA inspection and enforcement procedures for imports rely on coordination with U.S. Customs with whom FDA has an excellent working relationship.

    Unless a domestic dental laboratory meets one of the requirements outlined, then they are exempt from registering with the FDA.

    Many laboratories outsource work to another laboratory some within the U.S. and some outside the U.S. Domestic-to-domestic outsourcing is pretty common. Many laboratories have found that outsourcing to another laboratory can be profitable and can save a laboratory time and the hassle of investing in additional equipment. Record keeping is the key.

    Regulation of Advertising and MarketingFDA prohibits misbranding of devices, including: false or misleading labeling; including proper disclosure language such as manufactured by or distributed byfailure to include required information (brief statement of intended uses and warnings, precautions, side effects and contraindications)If the laboratory delivers the restoration in a box marked with only the laboratorys name and does not include either the manufactured by or distributed by language then the dentist assumes that the delivering laboratory was the producer of the restoration and therefore is mislead. This is a violation of the FDA regulations.Although domestic-to-domestic outsourcing is still the most common practice, it is still important that you protect your laboratory by following a few simple practices.Ignorance of the law is not an acceptable excuse fro non-compliance. For most dental laboratories, compliance will not be a burden. Compliance is a simple matter of continuing the quality practices in which you likely already do, but adding a step by documenting them appropriately.Manufacturers must comply with current good manufacturing practices, which is the quality systems regulations. These regulations are applicable to all manufacturers of finished devices. If a manufacturer engages in only some of the activities regulated by GMP/QSR, then they only need to comply with those regulations. Dental laboratories are limited in the scope of what we need to comply with under 21 CFR (Code of Federal Regulations) 820.