The Product Classification Files (excel format) contains (based on package you selected) Product code, device names, device class, regulation number (21 CFR), review panel, medical specialty, GMP exempt, submission type (510k, PMA, HDE, EAU), Implant, life sustain support, and malfunction reporting.
The Product Code assigned to a device is based upon the medical device product classification designated under 21 CFR Parts 862-892.
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. The three classes and the requirements which apply to them are:
Device Class and Regulatory Controls
1. Class I General Controls
- With Exemptions
- Without Exemptions
2. Class II General Controls and Special Controls
- With Exemptions
- Without Exemptions
3. Class III General Controls and Premarket Approval
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