Oivd PowerPoint PPT Presentations

Title: FDA Regulation Author: CDRH Last modified by: CDRH Created Date: 10/20/2003 4:31:03 PM Document presentation format: On-screen Show Company

Title: No Slide Title Author: Diane Perticone Last modified by: SSA Created Date: 2/23/1999 4:47:04 PM Document presentation format: On-screen Show

Regulatory Considerations for Investigational Assays: Planning for Success Elizabeth Mansfield, PhD OIVD/FDA Next-Generation DNA Sequencing as a Tool for Clinical ...

CDRH/FDA New Draft Guidance for Multiplex Tests Elizabeth Mansfield and Michele Schoonmaker Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Regulatory Considerations for Investigational Assays: Planning for Success Elizabeth Mansfield, PhD OIVD/FDA Next-Generation DNA Sequencing as a Tool for Clinical ...

Massachusetts Medical Device Industry Council (MassMEDIC) FDA Update ... fail to proofread correspondence. Don't cite other firms' ... www.fda.gov/cdrh/oivd ...

Class II Special Controls Guidance Document: RNA Preanalytical Systems (RNA ... Class II Special Controls Guidance Document: Factor V Leiden DNA Mutation ...

... good news ... halo effect good business, bad science. Predictive Marker ... Bad business, bad science. IVD Life Cycle. Analytical Validity. Clinical ...

Qualification of a biomarker means developing the correlative ... from Studies Evaluating Diagnostic Tests (March 07) http://www.fda.gov/cdrh ... Pre-IDEs ...

Glucose tests. Drugs of Abuse tests. Therapeutic Drug Monitoring. Division of Immunology ... Personalized medicine, drug/device co-development, companion diagnostics, ...

Multiplex Tests for Heritable DNA Markers, Mutations and Expression Patterns: ... Roche AmpliChip CYP450 Test (CDRH de novo 510(k) K042259) ...

BIORESEARCH MONITORING & IN VITRO DIAGNOSTIC DEVICES Presented by Jean Toth-Allen, Ph.D. Biophysicist/Consumer Safety Officer Division of Bioresearch Monitoring

Qualification of a biomarker means developing the correlative information that ... See the Center for Devices and Radiological Health website at http://www.fda.gov ...

Supplements, 99% of decisions and 99% of cohort meets goal (action within 120 calendar days) ... making it difficult to complete reviews in 90 calendar days. ...

Title: RefWorks Author: FRANCIS Last modified by: FRANCIS Created Date: 8/30/2004 2:43:41 PM Document presentation format

FDA Regulation of Pharmaceuticals and Devices Jean Toth-Allen, Ph.D. Good Clinical Practice Program Office of Science and Health Coordination Office of the Commissioner

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Alzheimer's and Parkinson's diseases. How to improve. Best of class methods ... association with a clinical condition. prediction of treatment response ...

Premarket Review Performance Goals MDUFMA Stakeholder Meeting November 18, 2004 Donna-Bea Tillman Director, Office of Device Evaluation Don St. Pierre

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Promoting and protecting public health by ensuring the safety and effectiveness ... Single Lumen Hypodermic Needle (2) Infusion Pump (6) AC Powered Adjustable Bed (6) ...

Historical overview of FDA regulation of digital pathology imaging applications: the safety and effectiveness issues Tremel A. Faison, MS, RAC, SCT(ASCP)

University of Pennsylvania Annual Conference on Statistical Issues in Clinical Trials: Emerging Statistical Issues in Biomarker Validation for Clinical Trials, 4/18/12

1. Medical Device Pathways to Market and Software Requirements ... Software requirements for IDEs are the same as those for other pre-market ...

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It is intended to meet the special needs of such physician or dentist, and ... named in the order of a physician or dentist, or is made in a specific form for ...

Pseudomembranous colitis, toxic megacolon, sepsis, and death ... Diagnosis and treatment of Clostridium difficile colitis. JAMA 1993;269:71-5 ...

Device Postmarket Studies. Danica Marinac-Dabic, MD, PhD. Chief, Epidemiology Branch ... Longer-term performance including effects of re-treatments & product changes ...

Medical Device User Fee and Modernization Act of 2002 (MDUFMA)

Department of Health and Human Services (DHHS) U.S. Food and Drug Administration (FDA) ... houses all data prior to submission of NDA. New Drug Application (NDA) ...

Application Integrity Policy/ Integrity Hold ... After evaluating all available information, including any explanation presented ...

If the lot number of the predicate used in your studies was recalled. 17 ... resulting from recalls, refer to 510(k) requirements for firm-initiated recalls. ...

... on U.S. Food and Drug Administration (FDA) mission, goals, ... Mission and Goals. The Food and Drug Administration Modernization Act (FDAMA) of 1997 affirmed ...

(1) identifying information (such as name or social security number) that would ... De-identified dataset ... Specimens/data distributed without identifiers ...

Title: FDA Perspective on the Implementation of Electronic Systems in the Blood Establishment Subject: Electronic Systems in the Blood Establishment

Director, Office of Science and Engineering Laboratories, CDRH ... Colonic polyp CAD. Computer phantom of cardiovascular disease. High-performance computing ...

Clinical Validation of Prognostic Biomarkers of Risk and Predictive Biomarkers of Drug Efficacy or Safety Gene Pennello, Ph.D. Team Leader, Diagnostics Devices Branch

of age) require hospitalization during 1st RSV infection ... 2nd to RSV as cause of lower respiratory tract disease in young children. ...

simple surgical instruments. Ophthalmic devices. intraocular lenses. PRK lasers, ... General, Surgical, and Restorative Devices. breast implants. artificial hips ...

Antimicrobial Drug Development and Resistance Initiatives. Office of Drug ... in 1753 attempting to replicate the 1752 kite experiment of Benjamin Franklin ...

CDRH promotes and protects the health of the public by ensuring the safety and ... product-specific websites -- e.g. Cochlear Implants www.fda.gov/cdrh/cochlear ...

Lead Medical Officer. Antimicrobial Drug Development and Resistance ... definitions of common terms. phases of drug development. Process of device development ...

Maltose - interference demonstrated at blood concentrations 13 mg/dL ... Lactose no interference up to 5 mg/dL (10x normal concentration of 0.5 mg/dL) ...