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Please note: as of October 1, 2002, FDA charges fees for review of Premarket Notification 510(k)s and Premarket Approvals
Most Class I devices and a few Class II devices are exempt from the
premarket notification [510(k)] requirements subject to the limitations on exemptions.
However, these devices are not exempt from other general controls. All medical devices
must be manufactured under a quality assurance program, be suitable for the intended use,
be adequately packaged and properly labeled, and have establishment registration and
device listing forms on file with the FDA.
A few Class I devices are additionally exempt from the GMP requirements with the exception
of complaint files and general record keeping requirements.
Devices exempt from 510(k) are:
For purposes of 510(k) decision-making, the term "preamendment device" refers
to devices legally marketed in the U.S. by a firm before May 28, 1976 and which have not
been:
Devices meeting this description are referred to as "grandfathered" and do
not require a 510(k).
This website contains a listing of medical devices exempt from 510(k) and Good Manufacturing Practices (GMP) compiled from Title 21 Code of Federal Regulations (CFR) and recent federal register announcements on class I exemptions and class II exemptions.
The Food, Drug and Cosmetic Act under section 513(d)(2)(A) authorizes
FDA to exempt certain generic types of Class I devices from the premarket notification
[510(k)] requirement. FDA has exempted over 800 generic types of Class I devices
and 60 class II devices from the premarket notification requirement. The
510(k) exemption is with certain limitations, which are so noted in ".9"
of each chapter. It is important to confirm the exempt status and any limitations
that apply with 21 CFR Parts 862-892 or the PRODUCT
CODE CLASSIFICATION DATABASE or subsequent FR announcements on class I exemptions and class II exemptions.
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.
How to Prepare A Traditional 510(k)
Requirements for Class I/II Exempt Devices
Even though a 510(k) is not required, it is necessary to meet other requirements for marketing. These include:
Updated February 9, 2000
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