Specific device indications 510(k) attachment added by FDA.
This article was originally published in The Gray Sheet
Executive Summary
SPECIFIC DEVICE INDICATIONS LISTING IN 510(k) CLEARANCE LETTERS "will reduce confusion between the agency and 510(k) submitters on which indications for use have been cleared," Philip Phillips, deputy director of the Center for Devices and Radiological Health's Office of Device Evaluation, says in a recent letter to device manufacturers. CDRH has begun clearing 510(k)s under a policy that requires sponsors to include in their premarket notifications a separate sheet "clearly" identifying "the indications for use for which a substantially equivalent determination is sought," along with the device name and the 510(k) number "if known."
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