FDA Approval

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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 ControlsApplication
Class IWith ExemptionsGeneral Controls* Exemptions
21 CFR xxx.9
Without ExemptionsGeneral and Special 510(k)
Class IIWith ExemptionsGeneral Controls and Special Controls* Exemptions
21 CFR xxx.9
Without ExemptionsGeneral Controls and Special Controls510(k)
Class IIIGeneral and premarket approval (PMA)PMA (postamendment** device)Or
510(k) (preamendments** device)
UnclassifiedDe 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

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

Feel free to contact us

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