A medical device is an instrument, appliance or piece of software designed by the manufacturer to be used for one or several of the following purposes:
- For the diagnoses, prevention, treatment or monitoring of a disease or injury
- For the investigation, modification, support or replacement of part of the anatomy or a physiological process
- For life support or life sustenance
- For controlling conception
- For the sterilization of medical devices
Medical devices fall into various categories. Class III medical devices are those which are considered to require the most rigorous monitoring because they present a “high risk” when it comes to patient safety. Examples of Class III medical devices include:
- heart valves
- pacemakers
- silicon-based breast implants
- cerebellar stimulators
The FDA requires UDI labeling of Class III medical devices.
What is Pre-market Approval?
The FDA has developed classifications for 1,700 types of medical device; these individual devices are grouped into 16 categories (known as panels). Each is then allocated a specific class. You may have a Class III device which requires pre-market approval (PMA). This is the most rigorous device marketing application required by the FDA. PMA is a procedure of medical and regulatory evaluation to ensure the effectiveness and safety of Class III devices. Applicants within the medical industry must receive approval of the PMA application from the FDA before being able to market the device. The FDA has 180 days to complete the review.
Our experts at Innovatum have been providing world-class compliance software for more than twenty years. We are dedicated to meeting the compliance challenges of highly regulated industries such as biotech, pharmaceuticals and medical devices. We are proud of our leadership role in the AIM North America UDI Committee and our technology, which includes a GS1 certified label design and print engine. Contact us today to find out how we can help you meet your UDI labeling needs.
