What is considered to be a Medical Device?
A medical device is a product, such as an instrument, machine, implant or in vitro reagent, that is intended for use in the diagnosis, prevention and treatment of diseases or other medical conditions. ISO 13485:2016 is designed to respond to latest quality management system practices, including changes in technology and regulatory requirements and expectations. The FDA's Center for Devices and Radiological Health (CDRH) is responsible for regulating firms who manufacture, package, relabel and/or import medical devices sold in the United States. The term medical device can range from a bedpan to a programmable pacemakers with a micro-chip technology.
How are Medical Devices Classified?
Medical Devices are classified into three distinct categories.
Class 1: Are deemed low risk and are always exempt from scientific review, but the company must pay a fee to register their products. Examples include canes, plastic bandages, thermometers and medical gloves.
Class 2: Pose a medium risk and could harm patients if the products are misused. Class 2 devices must submit a PreMarket Notification, examples include condoms, acupuncture needles and x-ray equipment.
Class 3: Reserved for the 10% of devices that pose the greatest risk. They are typically used to support life and are often implanted into the body. Examples include pacemakers, heart valves and balloon catheters.
510(k): A premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device.
Investigational Device Exemption (IDE): An IDE allows the investigational device to be used in a clinical study to collect safety and effectiveness data.
Cleared VS. Approved Devices
Cleared: FDA has determined to be substantially equivalent to another legally marketed devices, a premarket notification submission is referred to as a 510(k) and must be submitted to the FDA to review and provide clearance.
Approved: This review and approval process is Class 3 Medical devices and require more rigorous review than the 510(k) review process.
The new division of Swiss Technologies, S.T.O.N.E. Medical, will be a contract manufacturer solely focused on medical devices and medical components.
Sources:
https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/default
https://www.fda.gov/medicaldevices/resourcesforyou/consumers/ucm142523.htm
https://www.fda.gov/medicaldevices/deviceregulationandguidance/databases/default.htm