A key medical device manufacturer has crafted a list of data it says reprocessors should submit for FDA premarket review of cleaning, processing and sterilization of certain 510(k) reprocessed devices under the new device user-fee law. Absent from the list are design data, which the original equipment manufacturer (OEM) industry had sought to include before the law was enacted. FDA has resisted requiring submission of design data on the grounds that doing so would make it impossible for hospitals to reuse single-use devices.