Guidance For Industry And Food And Drug Administration Staff - U.s. Department Of Health And Human Services - 2012 Page 6
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13Contains Nonbinding Recommendations
classified the device type. While the great majority of device classifications codified in 21
CFR parts 862-892 are of pre- amendments devices, some of these classifications are of post-
amendments devices.
III. Obtaining Information About a Device
A.
General Information
You can obtain information about device classification and regulatory requirements
applicable to a type of device in several ways. FDA's device regulations may be found at 21
CFR parts 800 - 898; the regulations classifying device types are located at 21 CFR parts 862
- 892. The
CDRH classification resources
on the CDRH web site can help you quickly
ascertain how your device type may be classified. You can also obtain information about the
regulatory requirements that may apply to a particular type of device on FDA’s web site (see
resources below).
·
Product Classification Database
·
510(k) Database
·
Premarket Approval Database
·
Class I and Class II Devices Exempt from 510(k) Requirements
·
Device Guidance Documents
· Division of Small Manufacturers International and Consumer Assistance
800-638-2041 or 301-796-7100, or by email at
DICE@cdrh.fda.gov
·
Office of Combination
Products, 301-796-8930, or by email at
combination@fda.gov
·
Information regarding particular types of devices regulated by
CBER.
If the resources listed above do not address your question, you may contact the premarket
review branch chiefs for more information. Contact information for the Office of Device
Evaluation (ODE) is available at
the CDRH Management Directory By Organization
(ODE).
Contact information for the Office of In Vitro Diagnostics Evaluation and Safety (OIVD) is
available at
the CDRH Management Directory By Organization
(OIVD). Contact
information for CBER is available at
Contacts in the Center for Biologics Evaluation &
Research
(CBER).
B.
Section 513(g) Request for Information
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