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Not All 510(k)s Are Special, But It Pays To Check

by Glen Emelock, The CRO Group

The CRO Group is pleased to announce successful completion of its first Special 510(k) premarket notification. Following ratification of the Food and Drug Administration Modernization Act of 1997 (FDAMA97), the FDA introduced two new forms of 510(k)s – the Abbreviated, and the Special. We will address the Abbreviated in another newsletter. To qualify for a Special, the same use indications and same technology must be used between predicate and new device. Also, the predicate and new device must both belong to the applicant. The benefits of the Special are many. The two most important: the submittal is smaller than the typical 510(k). And instead of the 90 day review time, FDA promises 30 day review. In our case, the Special 510(k) cleared in 28 days!

The Special 510(k) may also be applied to virtually all 510(k) submissions.  In addition to the general rules explained above, the Special 510(k) relies on the presence and availability of evidence of design controls as is specified in 21CFR820, the Quality System regulation (or QSr).  This should not pose a problem for most medical device manufacturers with Design Controls in place (which were required for most companies since June of 1997, and enforced since June of 1998.  Because of this,  it is our experience that ISO 9000 / EN 46000 certified companies should be able to take advantage of the Special 510(k) most often.

For more information concerning 510(k) services contact Eisner Safety Consultants.