Answer 4 questions to determine whether your device is Class I, II, or III -- and whether a 510(k) or PMA is required.
21 CFR Parts 862-892 4 Questions Instant Result
1
Device Type
2
Contact Type
3
Risk Level
4
Life Support
✓
Result
Question 1
What type of medical device do you have?
21 CFR Parts 862-892
Select the primary category that best describes your device:
Choose the category that matches your device\'s primary function. If your device spans multiple categories, choose the primary intended use.
Question 2
How does the device interact with the patient?
21 CFR Part 860.3
Select the type of patient contact:
The nature and duration of patient contact is a key factor in FDA\'s risk-based device classification system.
Question 3
What is the consequence if the device malfunctions?
21 CFR Part 860.3(c)
If this device failed or malfunctioned, what would be the likely impact on the patient?
FDA\'s classification is heavily driven by the risk of harm to the patient if the device does not perform as intended.
Question 4
Is the device life-sustaining or life-supporting?
21 CFR Part 860.3(e)
Is this device intended to sustain, restore, or support a vital bodily function?
Life-sustaining devices (ventilators, pacemakers, dialysis machines) face the strictest regulatory requirements. Even if your device is used in a supporting role, select Yes if failure could directly cause patient death.
Classification Complete
Your FDA Device Classification
For informational purposes only. This tool provides a preliminary classification estimate based on FDA guidelines. Always confirm your device classification with an FDA regulatory consultant or by searching the FDA Product Classification Database.