The Food and Drug Administration (FDA) has established classifications for approximately 1,700 different generic types of devices and grouped them into 16 medical specialties referred to as panels. Each of these generic types of devices is assigned to one of three regulatory classes based on the level of control necessary to assure the safety and effectiveness of the device.
Device Class and Regulatory Controls:
1. Class I General Controls
2. Class II General Controls and Special Controls
3. Class III General Controls and Premarket Approval
the Federal Food Drug & Cosmetic (FD&C) Act define medical device as an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is
(1) recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them,
(2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
(3) intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.
- Premarket Notification(510k)
- Establishment Registration
- Medical Device Labeling
- UDI submission
- ISO 13485 certification
- CE Marking
- 21 CFR 820