How to get FDA approval?
The Food and Drug Administration (FDA) is the United States body responsible for protecting public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices. When targeting the US market, the first hurdle to consider is the lengthy and arduous process of medical device registration with the FDA.
A medical device company will choose the appropriate regulatory pathway depending on the risk class of the device. In some cases a device may be exempt from registration with the FDA.
The three classes and their respective requirements are as follows:
| Class | Controls | Application | |
|---|---|---|---|
| Class I | With Exemptions | General Controls | * Exemptions 21 CFR xxx.9 |
| Without Exemptions | General and Special | 510(k) | |
| Class II | With Exemptions | General Controls and Special Controls | * Exemptions 21 CFR xxx.9 |
| Without Exemptions | General Controls and Special Controls | 510(k) | |
| Class III | General and premarket approval (PMA) | PMA (postamendment** device)Or | |
| 510(k) (preamendments** device) | |||
| Unclassified | De novo | ||
* xxx refers to Parts 862-892.
** Pre/post-amendment device = devices marketed before/after May 1976, when the Medical Device Amendments came into effect.
Application paths
The 510(k) process applies to all non-exempt medical devices which do not require Premarket Approval (PMA). This is the most common approval pathway for medical devices. It is used to demonstrate that a device is as safe, effective, and substantially equivalent to a predicate device that is already legally marketed in the US.
A medical device is considered substantially equivalent to a predicate device if they:
• have the same intended use; and
• have the same technological characteristics;
or
• have the same intended use; and
• have different technological characteristics and the device does not raise different questions of safety and effectiveness; and
• the information submitted to FDA demonstrates that the device is as safe and effective as the legally marketed predicate device.
Premarket Approval (PMA) is required for Class III devices classified as “posing a significant risk of illness or injury”, or which are not substantially equivalent (NSE) to other devices previously certified by the FDA. This is the most stringent approval process and requires clinical data to support claims made in connection with the device.
De novo is a classification of innovative, moderate to low risk devices for which no legally marketed FDA approved device exists upon which to base substantial equivalence. In the De Novo pathway, the classification of the device is based on its risk.
How can we help?
When marketing a medical device, speed to market represents a crucial competitive advantage. Li-Med’s experts are highly experienced in navigating the ever-changing regulatory maze and will guide you through the FDA device clearance process to accelerate processes, promote your company’s success, and lead to profitability
With the help of Li-Med’s experts, you will be able to easily classify of your device, resolve compliance issues, provide a regulatory perspective for managerial decisions, and submit all necessary forms, requests, and obligatory fees. By doing so, you will save precious time and money thereby expediting your success
