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HHS Guidance Submissions

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Title OpDiv/StaffDiv Guidance Status Issue Date
Guidance for the Content of Premarket Notifications for Penile Rigidity Implants - Guidance for Industry and for FDA Staff  Food and Drug Administration (FDA) Final
Guidance for the Content of Premarket Notifications for Urine Drainage Bags  Food and Drug Administration (FDA) Final
Guidance for the Development of Vaginal Contraceptive Drugs (NDA)  Food and Drug Administration (FDA) Final
Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh - Guidance for Industry and/or for FDA Reviewers/Staff and/or Compliance  Food and Drug Administration (FDA) Final
Guidance for the Preparation of a Premarket Notification for Extended Laparoscopy Devices (ELD)  Food and Drug Administration (FDA) Final
Guidance for the Submission of Cabinet X-Ray System Reports Pursuant to 21-CFR 1020.40   Food and Drug Administration (FDA) Final
Guidance for the Submission of Premarket Notifications for Photon-Emitting Brachytherapy Sources - Guidance for Industry  Food and Drug Administration (FDA) Final
Guidance for the Submission of Premarket Notifications For Radionuclide Dose Calibrators - Guidance for Industry  Food and Drug Administration (FDA) Final
Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials (PDF Version)  Food and Drug Administration (FDA) Final
Guidance on 510(k) Submissions for Keratoprostheses - Guidance for Industry and for FDA Reviewers/Staff  Food and Drug Administration (FDA) Final
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