From cervical collars to bib holders and from syringes to inhalers, all medical devices are generally coined as medical supplies. Medical devices are manufactured in a regulated environment in the USA under the watchful eyes of the FDA. Therefore, whatever medical devices are marketed in the country is deemed to be safe for use. The devices that are sold in the market use marketing channels to make it available to end users. However, manufacturers are completely responsible for its quality and have to go through a rigorous procedure to introduce it to the market. The process is controlled by the Food and Drugs Administration (FDA) and is quite complex.
Devices are classified
According to the FDA, medical devices have to be classified according to its type of medical supplies. A class is assigned to the device depending upon intended use, indications for use and risk to users. Class I signifies devices with lowest risks that are kept under general controls. Special controls have to be applied in addition to general controls for Class II devices that pose moderate risks. Class III devices are high risk ones for which pre-market approval is must in addition to all other controls. First you have to classify the device that it belongs to.
Pre-market submissions are not all alike
If the medical device you intend bring into the market belongs to the category of medical supplies that is equivalent to a legally marketed device that did not require pre-market submission then you have to comply with pre-market notification 510(k). Pre-market Approval Application is a very stringent process and the product has to be backed by scientific evidence for effectiveness and safety. A Class III device without any lineage to predicate devices can be considered to be classified as Class I or II provided it meets certain criteria. This method is known as De Novo Evaluation. A third option, Humanitarian Device Exception is available for devices that are beneficial for patients suffering from rare conditions and diseases.
Take care of pre-market submission
Special guidance from experienced consultants can help in pre-market submission. A lot of information about clinical evidence, non-clinical testing, design controls and labeling related to the class to which the device belongs is critical. The higher is the risk accompanied with the device much more is the requirement of information for it. Usability data and clinical data are required much more extensive for high risk devices than devices with low risk. Bench test information and non-clinical performance data are sufficient for clearing devices with low risk.
Submission to FDA
The compiled information has to be submitted to FDA together with an electronic copy and accompanied with the necessary fees for Premarket approval application (PMA) or 510(k). FDA reviews the submission to assess adequacy and it can take between 90 and 180 days for getting a response – the longest time being taken for high risk devices.
Once pre-marketing approval is granted, the device is listed with FDA after registering the establishment of the device.