Presentations added to Public Workshop

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The Public Health Evidence for FDA Oversight of Laboratory Developed Tests: 20 Case Studies

Read the full report (PDF – 516KB) Executive Summary Laboratory developed tests (LDTs) serve an increasingly important role in health care today. They also have become significantly more complex and higher risk, with several notable examples of inaccurate tests placing patients at otherwise avoidable risk. While laboratories that offer LDTs are subject to the Federal…

Why FDA Should Oversee Laboratory Developed Tests

By: Peter Lurie, M.D., M.P.H. Today FDA is issuing a report that illustrates the real and potential harms to patients and to public health from certain laboratory developed tests (LDTs) – tests that are designed, manufactured and used in a single laboratory. When FDA first began regulating medical devices under the Medical Device Amendments in…

Presentations for the Public Workshop

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Amendment of Meeting Notice: November 18-19, 2015 Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-N-0001] Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Amendment of Notice AGENCY:  Food and Drug Administration, HHS. ACTION:  Notice. SUMMARY:  The Food and Drug Administration (FDA) is canceling the November 18, 2015, session and postponing the November 19, 2015,…

PMA Final Decisions for September 2015

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FDA Recommends Health Care Facilities Transition from Custom Ultrasonics Endoscope Washer/Disinfectors to Alternate Reprocessing Methods: FDA Safety Communication

Date Issued: November 13, 2015 Audiences: Personnel working in endoscopy reprocessing units in health care facilities Health care providers that perform endoscopic procedures Infection Control practitioners Risk Managers Purchasers and other Hospital Administration staff Medical Specialties: Infection Control, Gastroenterology, Pulmonology, General Surgery, Anesthesiology, Internal Medicine Product: All Custom Ultrasonics Endoscope Washer/Disinfector models, also known as…