Medical Device
About[]
A medical device (biomedical/medical equipment) is an instrument, apparatus, implant, in vitro reagent, or similar or related article that is used to diagnose, prevent, or treat disease or other conditions, and does not achieve its purposes through chemical action within or on the body (which would make it a drug).[1] Whereas medicinal products (also called pharmaceuticals) achieve their principal action by pharmacological, metabolic or immunological means, medical devices act by other means like physical, mechanical, or thermal means. Medical devices vary greatly in complexity and application. Examples range from simple devices such as tongue depressors, medical thermometers, and disposible gloves to advanced devices such as medical robots, cardiac pacemakers, and neuroprostheses.
The global medical device market reached roughly 209 billion US Dollar in 2006.[2]
References[]
- ↑ Summarised from the FDA's definition as per http://www.fda.gov/medicaldevices/deviceregulationandguidance/overview/classifyyourdevice/ucm051512.htm
- ↑ "Market Report: Wt". Acmite Market Intelligence.
Links[]
- US Food and Drug Administration – Center for Devices and Radiological Health
- Premarket Notification (510k)
- Premarket Approval (PMA)
- Device Advice – Is the Product a Medical Device?
- 11.040.01: Medical equipment in general – ISO standard series
- UK Medicines and Healthcare products Regulatory Agency: 'How we regulate medical devices'
Video[]
Idea to IDE A Medical Device in the Making