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1338. Supplements for approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) submissions during the Coronavirus Disease 2019 (COVID-19) public health emergency (revised): guidance for Industry and Food and Drug Administration staff

1339. Feasibility and early feasibility clinical studies for certain medical devices intended to therapeutically improve glycemic control in patients with Type 2 Diabetes Mellitus: guidance for industry and Food and Drug Administration staff