Regulatory
Class III Device
In one line
FDA's highest-risk device class, generally requiring PMA.
Definition
Class III devices are those that support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential, unreasonable risk of illness or injury. They generally require PMA.
Some older preamendments device types were historically cleared through 510(k) until FDA called for PMAs. In the EU, Class III is also the highest risk class under the MDR, requiring notified body review of the technical documentation and, for some implantables, a clinical evaluation consultation procedure.
Why it matters
Examples include implantable defibrillators and life-supporting devices. Class III devices undergo the most stringent regulatory review.
Common pitfalls
- •A common pitfall is misinterpreting the criteria for Class III, assuming only "life-sustaining" devices qualify, missing those preventing impairment or posing unreasonable risk.
- •Another mistake is underestimating the time and resources required for a Class III PMA submission, leading to significant project delays.
- •Failing to adequately address clinical evidence requirements for Class III devices is a frequent pitfall, as these devices demand robust safety and effectiveness data.
- •Thinking a device is Class II solely because it is not implantable or life-supporting can be a pitfall, as other risk factors can elevate classification.
- •Incorrectly applying predicates for substantial equivalence to Class III devices, where PMA is typically required, is a common error.
Sources
- FDA - Medical Devices · FDA
- European Commission - Medical Devices · European Commission
- IMDRF Documents · IMDRF