In the last column (See Archives), we discussed the general regulatory requirements for Class I, Class II and Class III medical devices.  This time, we will discuss the adulteration and misbranding and False and Misleading Labeling General Controls requirements for medical devices. 

General Controls were established by the Medical Device Amendments of 1976 to give the FDA the basic authority to regulate of devices to ensure their safety and effectiveness.   General Controls apply to all devices regardless of their classification status. Some devices have been exempted from General Control Provisions.

We have already discussed (See Archives) two General Controls: Establishment Registration and Medical Device Listing.  Now, let us discuss the some of the others. 

1. Adulteration

Adulteration for medical devices was first defined in Section 501 of the Federal Food, Drug and Cosmetic Act of 1938 (FD&C Act).  In 1976, the Medical Device Amendments added additional provisions. You will understand some of these provisions better later when we discuss in more detail the different type of FDA submissions.

According to these provisions, a device is adulterated if:

• It includes any filthy, putrid or decomposed substance 

• If it is prepared, packed or held under unsanitary conditions 

• Its container is composed, in whole or part, of any poisonous or deleterious substance

• It contains, for the purposes of coloring only, an unsafe color additive

• Its strength differs from, or its purity or quality falls below, that which it claims to represent.

• It is subject to a performance standard and does not comply with all the requirements of the standard;

• It is a Class III device and fails to conform to the requirements for an approved premarket approval application or a notice of completion of a product development protocol

• It is a banned device

• It is in violation of good manufacturing practice requirements (GMP)

• It fails to comply with an Investigational Device Exemption (IDE)

If you are a manufacturer of a medical device and market your products in the United States, it is critically important that you follow FDA’s Quality Systems Regulation.  See http://www.fda.gov/cdrh/qsr/03desgn.html#introduction .  Contained in this regulation are the GMP requirements of section 520(f) of the Act as well as design validation requirements, which were added by the Safe Medical Devices Act of 1990.  If your manufacturing facility does not comply with GMPs, your products could be considered to be “adulterated”!  We will talk more about this important regulation later.

2. Misbranding

Misbranding provisions are found in Section 502 of the FD&C Act. These are the first seven bullets below and apply both to devices and drugs. Additional provisions were added by the Medical Device Amendments applicable to just devices. A device is deemed to be misbranded if:

• Its labeling is false and misleading

• Its packaging does not bear a label containing:

1. The name of the place of business of the manufacturer, packer, or distributor, and

2. An accurate statement of the quantity of contents in terms of weight, measure, or numerical count.

Reasonable variations and exemptions for small packages may be permitted.

• Any word, statement, or other required information is not prominently placed on the labeling or not clearly stated so as to be read and understood by the ordinary individual under customary conditions of purchase and use.

• It is for use by man and contains any quantity of a narcotic or habit forming substance, unless its label bears the name and quantity or proportion of the substance or derivative and the statement "Warning - may be habit forming."

• Its label does not bear adequate directions for use. The label must include warnings against use in certain pathological conditions or by children where its use may be dangerous to health, or against unsafe dosage or methods or duration of administration or application. Adequate directions and warnings must be present when it is necessary to protect the health of the user. Exemptions to this provision may be obtained. The phrase "adequate directions for use" pertains to over-the-counter drugs and device.

• It is dangerous to health when used in the dosage or manner, or with the frequency or duration prescribed, recommended, or suggested in the labeling.

• It does not comply with the color additive provisions listed under Section 706 of the FD&C Act.

• The device's established name (if it has one) or its name in an official compendium, or any common or usual name, is not prominently printed in type at least half as large as that used for any proprietary name or designation. Exemptions from this provision may be granted.

• A restricted device offered for sale in any State uses false or misleading advertising, or is sold, distributed, or used in violation of restricted device regulations. (A Restricted device is a device for which the FDA Commissioner, by regulation, under Title 21 of the U.S. Code of Federal Regulations, Sec. 801.109 or otherwise under section 520(e) of the FD& C Act, has restricted sale, distribution, or use only upon the written or oral authorization of a practitioner licensed by law to administer or use the device or upon such other conditions as the Commissioner may prescribe).

A restricted device manufacturer, packer, or distributor fails to include in all advertisements or other descriptive materials:

• A true statement of the device's established name, prominently printed, and

• A brief statement of the intended uses of the devices and relevant warnings, precautions, side effects, and contradictions.

• The device commercially distributed without FDA concurrence on a Section 510(k) submission.
• The device is subject to a performance standard and it does not bear the labeling prescribed in that standard.
• There is a failure or refusal to comply with any requirement prescribed under section 518 (Notification and Other Remedies); to furnish any material or information required by or under Section 518; or to furnish any material or information requested by or under Section 519 (Records and Reports on Devices).  (We will discuss this later)

3. False or Misleading Labeling

A drug or device is misbranded if its labeling is false or misleading in any particular (FD&C Act).  The labeling must bear adequate directions for use and any warnings needed to ensure the safe and effectiveness use of the device It is important to understand that "labeling" includes the label and any other written, printed, or graphic material that accompanies a device and any of its wrappers or containers. Operating and servicing instructions are also considered to be labeling.  Most, if not all advertising, is considered to be labeling.  In fact, even the signs and hand-outs at an exhibit booth are regarded as labeling!  If any of these claims extended your intended use beyond what was cleared by the FDA, your product could be deemed to be “misbranded”!  The same is true for your website!  The FDA actively monitors these areas.

The FDA has a number of useful guidance documents that explain labeling requirements in greater detail. For example, see http://www.fda.gov/cdrh/dsma/470.pdf, http://www.fda.gov/cdrh/g91-1.html  and http://www.fda.gov/cdrh/ode/labeling.html .  My favorite guidance document is http://www.fda.gov/cdrh/dsma/897.pdf.  This document is entitled “Write it Right” and includes valuable advice on how to write instruction manuals so that users can better understand them.

In the next column, we will continue with our discussion of General Control requirements.  In the meantime, remember there are no stupid questions.  There are only stupid answers.  So, it’s my problem not yours if you have a question!

Norman F. Estrin, PhD, RAC

January 26, 2003