FDA Regulations for Medical Devices
Each device is assigned to one of three regulatory classes: Class I, Class II, or Class III, based on the level of control necessary to provide reasonable assurance of its safety and effectiveness [For further guidance, follow to Classify Your Medical Device or FDA]
Class I (low to moderate risk): general controls
These devices present minimal potential for harm to the user and are often simpler in design than Class II or Class III devices. Examples include enema kits and elastic bandages. 47% of medical devices fall under this category, and 95% of these are exempt from the regulatory process.
Class II (moderate to high risk): general controls and special controls
Most medical devices are considered Class II devices. Examples of Class II devices include powered wheelchairs and some pregnancy test kits. 43% of medical devices fall under this category.
Class III (high risk): general controls and premarket approval (PMA)
These devices usually sustain or support life, are implanted, or present potential unreasonable risk of illness or injury. Examples of Class III devices include implantable pacemakers and breast implants. 10% of medical devices fall under this category.
Exempt
If a device falls into a generic category of exempted Class I devices, a premarket notification application and FDA clearance is not required before marketing the device in the U.S. However, the manufacturer is required to register their establishment and list its generic product with FDA. Examples of exempt devices are manual stethoscopes, mercury thermometers and bedpans.
Some Class I and most Class II devices require a 510(k) application, where the product holder must demonstrate that the new device is "substantially equivalent" to a predicate device in terms of intended use, technological characteristics, and performance testing, as needed.
For Class III devices, a premarket approval application (PMA) will be required unless the device is a pre-amendment device and PMAs have not been called for.
