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As specified in regulations at 419.66(b)(1) through (3), to be eligible for transitional pass-through payment under the OPPS, a device must meet the following criteria: If required by FDA, the device must have received FDA approval or clearance and FDA marketing authorization (except for a device that has received an FDA investigational device exemption (IDE) and has been classified as a Category B device by FDA), or meet another appropriate FDA exemption

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In this context, Li et al

As Imai (2018) notes, such urban thresholds reflect a broader tension between decay and renewal, informality and regulation, collective memory and emerging urban conditions