Abbreviated 510(k)s

OIVD 510(k) Workshop
Veronica Calvin
April 22-23, 2003

[Powerpoint]

Abbreviated 510(k)

• Relies on the use of guidance documents¹, special controls², and recognized consensus standards³.

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¹ http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfggp/search.cfm or CDRH Facts-on-Demand (800-899-0381)

² Section 513(a)(1)(B) of the FD&C Act

³ http://www.fda.gov/cdrh/stdsprog.html or CDRH Facts-on-Demand

Abbreviated 510(k) Contents

• Required elements in 21 CFR 807.87
• Summary report – use of guidance document and/or special control(s) during device development and testing
• Declaration of conformity to recognized standard
• Data/information to address issues not covered by guidance documents, special control(s), and/or recognized standards

Declaration of Conformity

• Identify the applicable standard that was met.
• Specify that all requirements were met, except for inapplicable requirements or deviations noted below.
• Identify any way in which the standard may have been adapted for application to the device under review.
• Identify any requirements that were not applicable to the device.
• Specify any deviations from the standard that were applied.
• Specify differences, if any, between the tested device and the device to be marketed, and justify the use of test results in these areas of difference.
• Provide the name and address of a test laboratory or certification body involved in determining the conformance of the device with the standard and a reference to any accreditations of those organizations.

Why Submit an Abbreviated 510(k)?

• Summary reports on the use of guidance documents and/or special controls or declarations of conformity to recognized standards may result in an "expedited" review.