Liquid Silicone Rubber (LSR) Components for Class III Medical Devices

Class III is the most stringent regulatory category for medical devices. Class III devices are usually present in applications essential to supporting or sustaining human life, and are often instrumental in the maintenance of human health. Premarket approval is the process required, with scientific review, to ensure the safety and effectiveness of Class III devices. Not all Class III devices require premarket approval to be marketed.

Class III devices which require premarket approval to be marketed are those that are:

1. Regulated as new drugs prior to May 28, 1976, also called transitional devices.

2. Devices found not substantially equivalent to devices marketed prior to May 28, 1976.

3. Class III pre-amendment devices which, by regulation in 21 CFR, require premarket approval.

Examples of Class III devices which require premarket approval include: replacement heart valves, silicone breast implants, and implanted neuro-stimulators.

Some Class III devices can be marketed with a premarket notification only. Those are post amendment (i.e., introduced to the U.S. market after May 28, 1976) Class III devices which are basically equivalent to pre-amendment (i.e., introduced to the U.S. market before May 28, 1976) Class III devices and for which the regulation calling for the premarket approval application has not been published in 21 CFR.

Class III devices which currently require a premarket notification include implantable pacemaker pulse generators and dental or endosseous implants.

For more information on Class III Medical Devices and how to classify your medical device, please visit the U.S. Food and Drug Administration website: http://www.fda.gov/cdrh/devadvice/313.html .