Understanding and Complying with the FDA

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Understanding and Complying with the FDA

• May 5, Western States Conference
• Presented by Bennett Napier, CAE

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Federal Regulatory Agencies With Purview over
Dental LaboratoriesU.S. Dept. of Labor, Wage
and Hour
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Why are dental laboratories being looked at now?

• Increase in import trade
• Aging population
• Additionally focus on cosmetic dentistry
• Increased awareness of the dental laboratory
  industry

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The amount of dental devices now being imported
into the United States is enormous.

• Bryan Benesch
• Office of Compliance, FDA

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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.

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Understanding the FDAs Objectives

• For 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.

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Medical Devices

• There 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 devices
• Class III Body appendages (arms, legs)
  prosthetic devices

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Import Trade Raises the Stakes

• The Food and Drug Modernization Act of 1997
• Section 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

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Timeline for FDA activities relative to Dental
Laboratories

• In 2003 FDA released guidance document
  onCAD/CAM dental restorationsSleep Apnea
  devicesClass 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

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From 2004 to Date FDA Activities

• FDA 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.

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REGISTRATION

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

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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?

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If you answered yes

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

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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.

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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

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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

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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

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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)

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Outsourcing

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

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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.

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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)

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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.

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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 Director
• Office of Compliance, FDA

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Documentation assists in Compliance

• Labeling/Pass Through
• Know where its Been
• Label where its Going
• Identify Chain of Distribution
• Material used in device (and oversighting
  agencies)
• Device
• MSDS Sheet/Identalloy Stickers (to meet US
  requirements)
• State Requirements(i.e. Prop 65 in CA)

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Quality Systems/Good Manufacturing Practices

• What is the criteria and how does your laboratory
  comply?

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Dental Laboratory Requirements and
Responsibilities

• All 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.

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QS/GMP Standards

• Corrective and Preventive Action
• Labeling and Package Control
• Handling, Storage, Distribution and Installation
• Records
• Servicing
• Statistical Techniques

• Design Controls
• Document Controls
• Purchasing Controls
• Identification/Traceability
• Production and Process Controls
• Acceptance Activities
• Nonconforming Product

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For More Information Please Contact
325 John Knox Rd, L103 Tallahassee, FL
32303 Toll Free [phone] Phone (850)
205-5626 Fax [phone]
www.nadl.org www.nbccert.org