From straightforward bedpans and tongue depressors to intricate pacemakers and closed-loop artificial pancreas systems, medical gadgets come in all shapes and sizes. In vitro diagnostic (IVD) items like reagents, test kits, and blood glucose metres are also considered medical devices. Additionally, certain radiation-emitting electronic goods that are used for medical purposes or make medical claims fall under the category of Medical Devices. These include, for instance, x-ray machines, medical lasers, and diagnostic ultrasound instruments.
These medical technologies are used to intervene and treat ailments, both acute and chronic, detect disease, track therapies, help the disabled, and support the elderly. Any device intended by the manufacturer to be used, either alone or in combination, for a medical purpose qualifies as a Medical Devices. This includes instruments, apparatuses, implements, machines, appliances, implants, reagents for in vitro use, software, materials, and other similar or related items.
When attempting to assess if a product is subject to FDA regulation as a medical device, the steps listed below may be useful.
Step 1: Examine your product to see if it satisfies the requirements of Section 201(h) of the Food, Drug & Cosmetic Act, which defines a medical device.
Step 2: Find out if there is a suitable product classification for your goods.