fda_device_classification
Returns the FDA classification for a type of medical device: risk class (I, II or III), three-letter product code, regulation number, medical specialty, definition, the usual premarket route (510(k), PMA or exempt), and whether it is an implant or life-sustaining. Answers "what class is my device?" and "do I need a 510(k)?" for start-ups, importers and consultants. Source: FDA product classification database via openFDA. US classification only; it does not cover UK/EU (UKCA/CE) classes, and exemptions can carry limitations set out in the regulation. (cost: 1 credit)
Input Schema
| Name | Required | Description | Default |
|---|---|---|---|
| code | No | string, optional (device or code required), three-letter FDA product code, e.g. "OLK" | |
| limit | No | integer, optional, 1-20, number of device types to return, default 10 | |
| device | No | string, optional (device or code required), generic device type, e.g. "pulse oximeter" |