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HHS Guidance Submissions

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Title OpDiv/StaffDiv Guidance Status Sort ascending Issue Date
Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
Clarification of Radiation Control Regulations For Manufacturers of Diagnostic X-Ray Equipment: Draft Guidance for Industry and Food and Drug Administration Staff   Food and Drug Administration (FDA) Proposed
Clinical Decision Support Software: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
Clinical Investigations for Prostate Tissue Ablation Devices: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
Content of Premarket Submissions for Management of Cybersecurity in Medical Devices: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
Conventional Foley Catheters - Performance Criteria for Safety and Performance Based Pathway: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
Cutaneous Electrodes for Recording Purposes - Performance Criteria for Safety and Performance Based Pathway: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
General Considerations for Animal Studies for Medical Devices: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
Implanted Brain-Computer Interface (BCI) Devices for Patients with Paralysis or Amputation - Non-clinical Testing and Clinical Considerations: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
Infectious Disease Next Generation Sequencing Based Diagnostic Devices: Microbial Identification and Detection of Antimicrobial Resistance and Virulence Markers: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
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