Registration and listing information is submitted by using FDA’s Unified Registration and Listing System (FURLS)/ Device Registration and Listing Module (DRLM) at: However, these manufacturers are required to register their establishment and list the generic category or classification name. If a manufacturer's device falls into a generic category of exempted class I devices as defined in 21 CFR Parts 862-892, a premarket notification application and FDA clearance is not required before marketing the device in the U.S.
Limitations of device exemptions are covered under 21 CFR xxx.9, where xxx refers to Parts 862-892. It is important to confirm the exempt status and any limitations that apply with 21 CFR Parts 862-892. Some 510(k) exemptions annotated with " \#\" are with certain limitations as noted in the footnotes. Only devices annotated by ( *) are also exempt from GMP except for general recordkeeping requirements and compliant files.įDA has exempted almost all class I devices (with the exception of Reserved Devices from the premarket notification requirement, including those devices that were exempted by final regulation published in the Federal Registers of December 7, 1994, and January 16, 1996.
All devices in this list are 510(k) exempt unless further qualified by a footnote. Following is a breakdown of 510(k) exempt and Good Manufacturing Practice (GMP)/Quality System exemptions listed by device class.
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