Today's News

Thursday, March 19, 1998

FDA classification of medical devices and pharmaceuticals

It is the orthopaedic surgeon's responsibility to know the FDA clearance status of any medical device or pharmaceutical used in the treatment of patients. These uses may be described and taught in presentations made during Academy Continuing Medical Education (CME) events and in "enduring materials" (e.g. publications, videos, electronic media products). The purpose of this policy is to guide Academy chairmen and faculty members in CME events as well as authors and presenters of enduring materials in presenting information about the FDA clearance status of medical devices or pharmaceuticals for the uses described in their presentations and materials.

The Food, Drug and Cosmetic Act of 1938, as amended, establishes the basic legal framework controlling the activities of producers of food, drugs, cosmetics and medical devices. The most comprehensive set of amendments to this Act occurred in 1976. The 1976 Medical Device Amendments ("Amendments") created a complex system for regulating the development, introduction, and marketing of medical devices. These Amendments require the FDA to classify or categorize all medical devices according to their safety and effectiveness. These classifications may vary for a medical devices based upon their "intended use." The Amendments create three classes of devices:

Class I Includes uses for those devices presenting little risk to the public and which are generally recognized as being both safe and effective. Neither quality and performance standards nor FDA pre-marketing regulatory approval are necessary. This classification is subject to minimal FDA oversight. This oversight includes only those general regulatory controls available to the FDA to assure safety and effectiveness (e.g., registration, listing and compliance with safety controls).
Examples of Class I devices include cast materials, crutches and wheelchairs.

Class II Includes uses for those devices determined by the FDA to offer some additional risk to the public above Class I devices, for which the above mentioned regulatory controls are not sufficient to assure safety and effectiveness, but for which sufficient information exists to develop performance standards. Device uses falling into this category must comply with the general requirements for Class I devices and, in addition, any other performance standards developed by the FDA.
Examples of Class II devices include intramedullary nails, bone screws and plates when used for long bone fractures, and cemented hip replacements.

Class III Includes uses for those devices for which general regulatory controls are not sufficient to assure safety and effectiveness, which may offer a substantial risk to the public and for which there is not sufficient information to establish a performance standard. Class III devices are generally considered to be "new" medical device uses requiring a showing of safety and effectiveness through a pre-market approval prior to labeling for the intended use. Class III devices may also be approved for certain intended uses if determined to be "substantially equivalent" to a pre-Amendment device.
Examples of Class III devices currently (9/97) include ligament replacements and bone substitutes and the use of bone screws in the pedicle.

Annual Meeting/CME Courses Educational Program


  1. Faculty Responsibility

    All Annual Meeting speakers and CME course faculty members are responsible for knowing the status of FDA clearance of medical devices and pharmaceuticals for the uses discussed, described, or demonstrated in their educational presentations. Faculty members who do not know the FDA clearance status of a device or pharmaceutical for the uses discussed, described or demonstrated can determine such status by examining the product package labeling, by contacting a sales representative or legal counsel of the manufacturer of the device or by contacting the FDA at 1-800-638-2041.

  2. Use of Generic and Trade Names

    It is important that Academy courses provide a balanced view of therapeutic options for the treatment of musculoskeletal patients. Faculty use of generic names to describe a device or pharmaceutical creates a sense of impartiality and is strongly encouraged. When a trade name is used in a presentation, the faculty member should, when possible, list or cite other similar devices or pharmaceuticals from other companies.

  3. Discussion of Investigational Use of Medical Devices or Pharmaceuticals

    Medical devices or pharmaceuticals not cleared by the FDA for an intended use are required by law to be labeled "for investigational use" if there is an existing IDE application for study of the intended use. When these investigational intended uses are discussed or described during an educational program, the faculty member shall disclose that the device or pharmaceutical is classified by the FDA as investigational with respect to the intended use. Results of scientific studies known to the faculty member relating to the described intended use should be discussed if doing so will not adversely affect the study or violate some other regulatory requirement (e.g., securities law).

  4. Discussion of "Off Label" Use of Medical Devices and Pharmaceuticals

    Some medical devices or pharmaceuticals not cleared by the FDA or cleared by the FDA for a specific use only may be used "off-label" (i.e., a use not described on the product's label) if, in the judgment of the treating physician, such use is medically indicated to treat a patient's condition. "Off label" uses of a device or pharmaceutical may be described in Academy CME events so long as the lack of FDA clearance for such uses is also disclosed. Results from scientific studies known to the faculty member relating to the described intended use should be discussed if so doing will not adversely affect the study or violate some other regulatory requirement.

  5. Academy CME Surgical Skills Events
    1. Faculty at Academy CME surgical skills events may demonstrate and conduct laboratory exercises using devices for uses for which the device has been cleared by the FDA.
    2. Faculty at Academy CME surgical skills events may demonstrate "off label" uses of devices if practice patterns develop and such use has become an accepted standard of practice, but only if the course chairman determines there is appropriate rationale for demonstrating such "off label" use. The lack of FDA clearance for a device in such use must be disclosed. Demonstration and laboratory exercises that include "off-label" uses of a device must receive approval from the Academy's Committee on Surgical Skills Education or Instructional Course Committee prior to the presentation at the course. The course chairman is responsible for submitting the request for the demonstration of an "off-label" use of a device.

Annual Meeting/CME Event Exhibits


  1. Annual Meeting Poster and Scientific Exhibits

    Each Annual Meeting poster and scientific exhibit shall include the FDA clearance status of medical devices and pharmaceuticals for the uses discussed or described in the exhibit. "Off label" uses of a device or pharmaceutical may be described in the exhibit so long as the lack of FDA clearance for such uses is also disclosed.

  2. Technical Exhibits or Displays of Medical Devices and Pharmaceuticals

    Exhibitors of medical devices or pharmaceuticals at the Academy's Annual Meeting or other CME event must maintain at the exhibit information regarding the FDA status of each device displayed. Exhibitors are reminded of the current FDA policy prohibiting them from promoting intended uses not cleared by the FDA.

  3. Signage at Technical Exhibits or Displays of Devices or Pharmaceuticals

    Exhibitors of medical devices or pharmaceuticals at the Academy's Annual Meeting or other CME event shall place signage next to the product display indicating the FDA cleared labeling of the product.

  4. Discussion of Off-Label Uses of Devices or Pharmaceuticals Prohibited at Technical Exhibits or Displays

    Exhibitors of medical devices or pharmaceuticals at the Academy's Annual Meeting or CME event are reminded of the current FDA policy prohibiting them from promoting "off-label" uses of such devices or pharmaceuticals.

  5. Discussion of Investigational Devices or Pharmaceuticals at Technical Exhibits or Displays

    Exhibitors of medical devices or pharmaceuticals approved for investigational study at the Academy's Annual Meeting or other CME event shall maintain at the exhibit information regarding the Investigational Device Exemption (IDE) record of such devices or pharmaceuticals. An exhibitor may make reference to an IDE only in the context of obtaining investigators.

Enduring Educational Materials


  1. FDA Clearance Status Included in Discussion of Devices or Pharmaceuticals in Enduring Materials

    If a medical device or pharmaceutical, not cleared by the FDA or cleared by the FDA for a specific use only, is discussed or described in an Academy enduring educational program or publication, the author or presenter is responsible for including the FDA clearance status of the product as it relates to the uses described in the materials at the time of publication. This information should be included in the enduring materials with the discussion or description of the product, and not in an appendix.

  2. Discussion of Investigational Uses of Devices or Pharmaceuticals in Enduring Materials

    Medical devices or pharmaceuticals not cleared by the FDA for an intended uses are required by law to be labeled "for investigational use" if there is an existing IDE application for study of the intended use. When these investigational intended uses are discussed or described during an Academy enduring educational program or publication, the author or presenter shall disclose that the device or pharmaceutical is classified by the FDA as investigational with respect to the intended use. Results of scientific studies known to the author or presenter relating to the described use should be discussed if doing so will not adversely affect the study or violate some other regulatory requirement.

  3. Discussion of "Off Label" Uses of Devices or Pharmaceuticals in Enduring Materials

    Some medical devices or pharmaceuticals not cleared by the FDA or cleared by the FDA for a specific use only may be used "off-label" (i.e., a use not described on the product's label) if, in the judgment of the treating physician, such use is medically indicated to treat a patient's condition. "Off label" uses of a device or pharmaceutical may be described in Academy enduring educational programs or publications so long as the lack of FDA clearance for such uses is also disclosed. Results from scientific studies known to the author or presenter relating to the described intended use should be discussed if so doing will not adversely affect the study or violate some other regulatory requirement.

  4. Use of Generic or Trade Names by Authors or Presenters

    It is important that Academy courses provide a balanced view of therapeutic options for the treatment of musculoskeletal patients. The use by authors or presenters of generic names to describe a device or pharmaceutical creates a sense of impartiality and is strongly encouraged. When a trade name is used in an enduring educational program or publication, the author or presenter should, when possible, list or cite other similar devices or pharmaceuticals from other companies.

On-Line Education/Information


Hyperlinks

When a visitor to the Academy's World Wide Web site initiates a hyperlink to a commercial web site included in the Academy's 'Orthopaedic Yellow Pages' section, the commercial site may contain information about medical devices or pharmaceuticals. The following disclaimer should be displayed prior to completing the link:

"You are now leaving the American Academy of Orthopaedic Surgeons World Wide Web site. Please be aware that the World Wide Web site you are linking to may contain information about medical devices and/or pharmaceutical products. Orthopaedic surgeons should be aware of the FDA clearance status of medical devices used in patient care. Information regarding the FDA clearance status of a particular device or pharmaceutical may be obtained by reading the product's package labeling, by contacting a sales representative or legal counsel of the manufacturer of the device or pharmaceutical, or by contacting the FDA at 1-800-638-2041."

Disclaimer


Some drugs or medical devices demonstrated in Academy education programs or materials have not been cleared by the FDA or have been cleared by the FDA for specific uses only. The FDA has stated that it is the responsibility of the physician to determine the FDA clearance status of each drug or device he or she wishes to use in clinical practice.

September 1997

Home
Previous Page
1998 Academy News Mar.19 Index C

Last modified 04/March/1998