Published on: 2022-00501. Final rule. 2022-00501. Revised Procedures for the Announcement of Approvals and Denials of Premarket Approval Applications and Humanitarian Device Exemption Applications
Published on: 2019-27045. Proposed rule. 2019-27045. Revised Procedures for the Announcement of Approvals and Denials of Premarket Approval Applications and Humanitarian Device Exemption Applications
Published on: 2019-27047. Final rule. 2019-27047. Medical Device Submissions: Amending Premarket Regulations That Require Multiple Copies and Specify Paper Copies To Be Required in Electronic Format
Published on: 2018-19865. Proposed rule. 2018-19865. Medical Device Submissions: Amending Premarket Regulations That Require Multiple Copies and Specify Paper Copies To Be Allowed in Electronic Format