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HHS Guidance Submissions

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Software as a Medical Device (SAMD): Clinical Evaluation: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Technical Considerations for Additive Manufactured Medical Devices: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices : Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
The Abbreviated 510(k) Program: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
The Content of Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications for Artificial Pancreas Device Systems: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
The Special 510(k) Program: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
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