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U.S. Department of Health and Human Services

Medical Devices

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Special Controls Guidance Documents to Reduce Regulatory Burden

The Center for Devices and Radiological Health recently developed a special controls guidance document that we believe will immediately reduce regulatory burden associated with obtaining marketing authorization for indwelling blood gas analyzers, as well as serve as a possible template for special controls guidance documents for other device types. The guidance document is entitled, "Class II Special Controls Guidance Document: Indwelling Blood Gas Analyzers; Final Guidance for Industry and FDA" and was developed to support reclassification of these preamendment devices from class III to class II.

This document presents an alternate approach to the traditional way of demonstrating substantial equivalence in a premarket notification (510(k)) submission. While it is not based on any new concepts, it does represent only the second guidance document that we have issued that takes full advantage of the Abbreviated 510(k) concept. The first guidance document of this type is entitled, "Latex Condoms for Men: Information for 510(k) Premarket Notifications: Use of Consensus Standards for Abbreviated Submissions."

In the case of latex condoms, an Abbreviated 510(k) submission relies very heavily on the use of recognized consensus standards as the way of satisfying performance requirements. While the special controls guidance document for indwelling blood gas analyzers also relies heavily on recognized consensus standards, it is designed to take advantage of The 510(k) Paradigm's concept of a "summary report." For more specific information regarding Abbreviated 510(k)s and "summary reports," please see "The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications; Final Guidance".

As you know, an Abbreviated 510(k) submission must include the required elements identified in 21 CFR 807.87. In an Abbreviated 510(k), FDA may consider the contents of a "summary report" to be appropriate supporting data within the meaning of 21 CFR 807.87(f) or (g). In appropriate circumstances, a summary report will be an efficient way for a 510(k) submitter to describe the methods used and the acceptance criteria applied to address the risks identified in a special controls guidance document, as well as any additional risks that may be specific to a particular device. A 510(k) that includes such a summary report relies less on a side-by-side comparison to another legally marketed device and more on addressing the risks that are known to exist with devices of the same type.

Please note that manufacturers may still choose to submit a Traditional 510(k) as a way of demonstrating substantial equivalence for an indwelling blood gas analyzer. In addition, depending on the specific circumstances, 510(k) holders may elect to submit a Special 510(k) for most device modifications. The approach suggested by this latest guidance document augments the other existing approaches to obtaining 510(k) clearance for indwelling blood gas analyzers. Nevertheless, it is our hope that the industry will find that the Abbreviated 510(k) proves to be the most efficient and least burdensome means of getting safe and effective indwelling blood gas analyzers to market in the United States.

After reviewing this guidance document, please provide any feedback that you may have to Ms. Heather Rosecrans at (301) 594-1190 or by e-mail to hsr@cdrh.fda.gov.