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Glossary Term
Exempt Devices
Definition
Exempt Devices are medical devices that are not subject to certain regulatory requirements, such as premarket notification (510(k)) or premarket approval (PMA). They are typically low-risk devices classified as Class I or certain Class II devices under the FDA’s regulatory framework. These devices are still required to comply with general controls, including labeling, good manufacturing practices (GMP), and post-market surveillance.
Relevance to the MedTech Industry
Exempt Devices streamline market entry for low-risk products, reducing the regulatory burden on manufacturers while maintaining safety and performance standards. This allows companies to focus resources on development and distribution rather than lengthy approval processes.
Additional Information & Related Terms
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