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"In-depth" 510(k) reviews will be completed within 90 days, CDRH's Burlington says.

This article was originally published in The Gray Sheet

Executive Summary

"IN-DEPTH REVIEW" ON ALL 510(K) SUBMISSIONS WITHIN 90 DAYS will be pursued by FDA's Center for Devices and Radiological Health for fiscal year 1996 (begun Oct. 1), CDRH Director Bruce Burlington says in a letter highlighting improvements in the center's device review program. "Our goal is to screen for completeness and perform at least one cycle of in-depth review on all submissions within a 90-day review cycle," Burlington says, at which time sponsors can expect to receive a determination of substantially equivalent, not substantially equivalent, or a request for additional data.

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