top of page
Glossary Term
510(k) Exemption
Definition
A 510(k) exemption refers to certain medical devices that are exempt from the FDA’s 510(k) premarket notification requirements, as they are considered low-risk and have well-established safety and effectiveness. Exempt devices are typically Class I or specific Class II devices that still need to comply with general controls, such as registration, labeling, and good manufacturing practices (GMPs), but do not require a premarket submission to the FDA.
Relevance to the MedTech Industry
510(k) exemptions streamline the regulatory process for low-risk devices, reducing time and cost for manufacturers while maintaining safety and compliance. This allows companies to focus resources on innovation and faster market entry for these products.
Additional Information & Related Terms
bottom of page