Plastics Use in Medical Devices

Medical devices are articles intended for the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the human body, but which do not create their effect by chemical or metabolic action. These devices are regulated by the USA, EU and other countries, and components of the devices, including plastics, are regulated in the course of regulating the devices.

USA
In the United States, medical devices are regulated by the Food and Drug Administration (FDA). Regulations may be found in 21 CFR, 803-895. FDA guidance documents may be found at: http://www.fda.gov/cdrh/devadvice/

FDA classifies devices as Class I, II and III. Most Class I Devices are exempt from Premarket Notification to FDA, most Class II Devices require Premarket Notification under Section 510(k) of the Federal Food, Drug, and Cosmetic Act, and most Class III Devices require Premarket Approval (PMA). Depending on the classification, biological testing of the device may be required (see discussion below for testing that may be required in USA and Europe). The link to the device classification database is found at: http://www.fda.gov/cdrh/devadvice/313.html

Class I devices are subject to the least regulatory control. They present minimal potential for harm to the user and are often simpler in design than Class II or Class III devices. Examples of Class I devices include elastic bandages, examination gloves, and hand-held surgical instruments.

Class II devices are those for which general controls alone are insufficient to assure safety and effectiveness. In addition to complying with general controls, Class II devices are also subject to special controls. Special controls may include special labeling requirements, mandatory performance standards and postmarket surveillance. Examples of Class II devices include powered wheelchairs, infusion pumps, and surgical drapes.

Class III is the most stringent regulatory category for devices. Class III devices are those for which insufficient information exists to assure safety and effectiveness solely through general or special controls. Class III devices are usually those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential serious risk of illness or injury.

The composition, manufacturing, and health and safety information about plastics marketed for use in medical devices or for packaging medical devices may be provided directly to the FDA by the material supplier in the form of a Device Master File (MAF). Like the Drug Master File (DMF), the MAF allows the material supplier to maintain confidentiality of submitted information. The manufacturer then grants FDA authorization to review the MAF to determine suitability of the material for the devices listed by specified customers in the customers' Premarket Approval Applications.

The guidance document issued by FDA for MAFs is http://www.fda.gov/cdrh/ode/338.pdf
The address listed in the guidance is no longer correct. The correct address is:

Food and Drug Administration
Centers for Device and Radiological Health
PMA Document Mail Center (HFZ-401)
9200 Corporate Blvd.
Rockville, MD 20850

Links to Additional Information:

Europe
In Europe medical devices are regulated by EU Directive 93/42/EEC (plus 90/385/EEC, 98/79/EC). Ordering information for the EU Directives may be found at: http://www.amtaclabs.bureauveritas.com/cert/d1a.htm or a copy may be downloaded at the following locations: http://www.fxtrans.com/medical/MDD93-42-EEC.pdf or http://europa.eu.int/eur-lex/en/consleg/pdf/1993/en_1993L0042_do_001.pdf

Device approval in Europe is granted by approved institutes, who conduct the tests mentioned below. Europe like FDA classifies devices according to risk. Depending on the type of tissue contact and the duration of contact various ISO 10993 Tests (Biological Investigation of Medical Devices) are required of the device manufacturer. Tests that may be required in Europe, USA and other countries include: cytotoxicity, sensitization, irritation, systemic toxicity, subchronic toxicity, genotoxicity, and implantation. Historically, U.S. Pharmacopeia (USP) Class VI tests were conducted for medical devices, but did not include cytotoxicity and sensitization tests, which are important for many medical devices.

Canada
Health Canada reviews medical devices (as defined in the Food and Drugs Act) to assess their safety, effectiveness, and quality before being offered for sale in Canada. Devices are classified according to risk. Class I devices do not require a license prior to sale. Classes II - IV require licenses.

Comprehensive information regarding medical device approval, including regulations and guidance may be found at: http://www.hc-sc.gc.ca/dhp-mps/md-im/index_e.html

Copyright © Society of the Plastics Industry, Inc., November 2005
Food, Drug, and Cosmetic Packaging Materials Committee
Medical and Personal Care Products Subcommittee

For additional information, please contact:
Susan Howe, Executive Director, showe@socplas.org

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