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The diversity of medical devices, ranging from urine specimen collection bottles to intraocular lenses, lasers, MRI Imaging and other high-tech modalities, was a starting place to think about the overall approach. The outcome was based on a risk management approach, establishing three risk categories. Class I devices are low-risk devices requiring general controls, such as Good Manufacturing Practice, to ensure safety. Class I devices do not require FDA Clearance or Approval prior to marketing. Class II devices may have a higher risk profile and be more complex, require general and special controls to ensure safety and effectiveness. Special controls may include, for example, mandatory performance standards, patient registries for implantable devices, and post-market surveillance. In addition Class II devices must be cleared by FDA prior to marketing unless specifically exempted. Clearance is obtained by demonstrating substantial Equivalence to a predicate device which has been cleared under the 510(k) process. Finally, Class III devices are defined as those that are life-sustaining, life supporting or pose significant potential for risks to patients. These devices require general controls, special controls and Pre-market approval is specifically required. In the majority of cases a clinical trial is required. Having established the paradigm for risk based regulation, FDA created classification panels with expertise in a wide variety of devices, therapeutic area, etc. to evaluate devices for risk assignment. The outcome of this process was the establishment of product categories which describe the devices included in that category.

What‘s a 510(K)?