Understanding and Complying with the FDA

May 5, Western States Conference

Presented 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 trade Aging population Additionally focus on cosmetic dentistry Increased awareness of the dental

laboratory industry

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

Bryan Benesch

Office 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 FDA’s Objectives

For the most part, the FDA’s 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 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 devicesClass III – Body appendages (arms, legs)

prosthetic devices

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

Timeline for FDA activities relative to Dental Laboratories

In 2003 FDA released guidance document on:CAD/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

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.

REGISTRATION

How 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)

Outsourcing

What 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 you’re going to use a

foreign firm that it meets all requirements.”

Harold “Wally” Pellerite

(former) Asst. to the Director

Office of Compliance, FDA

Documentation assists in Compliance

Labeling/Pass Through Know where it’s Been Label where it’s 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)

Quality Systems/Good Manufacturing Practices

What is the criteria and how does your laboratory comply?

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.

QS/GMP Standards

Design Controls Document Controls Purchasing Controls Identification/Traceability Production and Process

Controls Acceptance Activities Nonconforming Product

Corrective and Preventive Action

Labeling and Package Control

Handling, Storage, Distribution and Installation

Records Servicing Statistical Techniques

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