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Referenced Citations Graf, M

3971 Small Business Innovation and Economic Security Act (Full Text) Statutory source for Strategic Breakthrough Awards, TABA expansion, and security screening: Great summary Eric, thank you

In the CY 2020 OPPS/ASC final rule with comment period, we finalized an alternative pathway for devices that are granted a Breakthrough Device designation (84 FR 61295) and receive FDA marketing authorization for the indication covered by the Breakthrough Device designation

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