FDA Publishes List of Class II 510(k) Exemptions
The FDA has released a draft document listing more than 1000 Class II devices, diagnostic tests and reagents it proposes to exempt from 510(k) premarket notification requirements.
In some cases, the agency may limit exemptions to specific devices or tests within a given type. For example, the draft list includes endoscopic magnetic retrievers but limits the exemption to those intended for a single use.
The document consists of two tables. Table 1 lists Class II devices and diagnostic tests such as glucose monitors, catheters, umbilical clamps, enzyme immunoassays, and thin layer chromatography.
Table 2 lists immunological test systems for various types of allergens.