• by Signup Training

Medical device manufacturers and distributors must have a good understanding of the Medical Device Regulations in the USA to operate their units successfully. This industry is highly driven by compliance and regulations, as safety is of utmost priority.

In the US, the medical device industry is regulated by the Food and Drug Administration (FDA). Medical devices are classified into 3 segments based on the risk factor – Class I, Class II and Class III, from lowest to highest risk.

There are 7 FDA regulations for Medical Devices:

1. Establishment Registration & Medical Device Listing

All medical device manufacturers and distributors must register themselves with the FDA in order sell in the market. The registration should be done electronically using the FURLS System (Unified Registration and Listing System). All registered companies are required to verify this information annually. The registration charges are usually revised every year.

2. Premarket Notification 510(k)

All medical devices for the purpose of human utility need to submit a premarket notification regardless of which class they fall under. For each of these devices with 510(k0 notification, the government must provide a clearance certificate to enables sales in the market. The FDA sends their approval in writing that the device is substantially equivalent (SE) and safe for commercial distribution. This process usually takes a period of 90 days from submission.

3. Premarket Approval (PMA)

Premarket approval is conducted by the FDA to check if the device is safe and effective. All Class III devices must go through a premarket approval as they’re considered to be high risk. This is one of the critical requirements that all medical devices must pass in order to start their marketing and distribution activities. Only once sufficient scientific evidence is available about the safety of the device can they be given a premarket approval. It could take as long as 180 days or even more to get a go ahead.

4. Investigational Device Exemption (IDE) for Clinical Studies

The Investigational Device Exemption is a provision given to manufacturers to allow them to collect relevant safety and effectiveness data before its released for commercialization. This data can be used by the manufacturers to as supporting information while applying for premarket notification and premarket approvals.

5. Quality System (QS) Regulation

The Quality System Regulation provides manufacturers and distributors clear guidelines about the regulatory norms for facilities and controls to be implemented throughout the lifecycle of the medical device. This includes activities related to purchase, packaging, storing, labelling and servicing. The QS Regulation provides a broad framework that must be followed by all medical device manufacturers.

6. Labelling Requirements

All medical devices must be appropriately labelled before they’re distributed for commercial purposes. The label should contain a description and information regarding usage.

7. Medical Device Reporting

As per FDA guidelines, it is mandatory to report any death or serious injury caused due to a malfunctioning medical device. This is to enable the timely detection of any issues with the medical device so that appropriate measures can be taken to avoid further accidents.

We’ve provided a short overview of the Medical Device Regulations of the FDA in the USA. However, you can sign up for a seminar on Medical Device Regulations with www.signupTraining.com to have a deeper understanding of this topic.