Medical Device Registrations in the USA - Decode the Regulatory Pathways

Currently valued at $156 billion, the USA is the largest market for medical devices in the world representing approximately 40% of the global market. Given the scenario, manufacturers are on constant look out to market their products in the region. Enroute, even a small error in the approach can result a device recall. Therefore, it is necessary for the manufacturer to be at par with the latest regulations of USFDA (US Food and Drugs Administration) and chose the right Regulatory pathway that suits their device’s classification.

Registering a device in the US

To register a device in the US, manufacturers should decode their device classification as defined by the FDA. According to FDA, medical device in the US are classified into three categories based on the risks associated. They are: Class I, Class II and Class III. Once the class of the device is decoded, the manufacturer can opt for the suitable Regulatory pathway for registering.

1. Pre-Market Notification

Pre-Market Notification 510(k) is filed in order to demonstrate the safety and effectiveness of a device. A 510(k) is submitted by the manufacturer if there exists a substantially equivalent (SE) device, one that has either same characteristics or use as the new device, which is already being marketed in the US market. If a manufacturer is sure that his device needs a 510(k), he can look through FDA’s Product Classification Database to find the suitable SE.

513(g) - Request for Information

In case, an SE does not exist for the device in the classification database, the manufacturer is suggested to file a 513(g) – and can request for the information from FDA. The main purpose of 513(g) is to inquire about the classification and Regulatory requirements of the device to be marketed. While submitting a 513(g), the manufacturer must mention:

• characteristics of the medical device for which there in no information in the classification database
• reasons as to why you think the device fall into the mentioned category

Once 513(g) is filed, FDA reviews the application and reverts in 60 days on how to classify your device. The classification is done solely on the basis of information provided in the 513(g) application and in response, the FDA provides the following information

1. Assessment of the device
2. Class of the mentioned device within the generic type
3. Other requirements, if any

2. Pre-Market Approval (PMA)

Pre-market Approval is the FDA’s scientific and Regulatory review of a Class III medical device and its safety and effectiveness. Class III devices are those which help sustain human life or which are important in preventing impairment to the human life. For such devices, FDA requires more than general and special controls to ensure the safety and effectiveness. Therefore, PMA depends on FDA’s inspection of scientific evidences of the PMA application and whether the device is safe and effective for its targeted users.

These two submission pathways are further categorized into three subtypes:

By now, you must have understood that if your device’s technology is as same as any predicate, then it is capable of 510(k) – Pre Market Notification and if not, and if your device falls into riskiest class that is Class III, then you can take a Pre-Market Approval (PMA) pathway. But there are other pre-market device submission pathways which are less followed and yet are successful. For more information on those pathways, kindly stay tuned. Be Informed. Be Compliant.