'Medicaldevices deviceregulationandguidance guidancedocuments' diaporamas de présentation

FDA Evaluation of Prescription Genetic Tests

Molecular and Clinical Genetics Panel for Direct-to-Consumer (DTC) Genetic Tests. FDA Evaluation of Prescription Genetic Tests. Reena Philip, Ph.D. OIVD/CDRH/FDA March 9, 2011. IVD Device Regulation. Safety

987 views • 79 slides

IMDMC Regulatory 101 Pathways to Market PMA, HDE, De novo 510(k)

IMDMC Regulatory 101 Pathways to Market PMA, HDE, De novo 510(k). May 15, 2014. Pathways to Market. 21 CFR 814 Subpart B Premarket Approval Application (PMA) 21 CFR 814 Subpart H Humanitarian Use Device (HUD) Humanitarian Device Exemption (HDE) Section 513(f)(2) of the FD&C Act

897 views • 52 slides

Oral Fluid Drug Tests: FDA Perspective

Oral Fluid Drug Tests: FDA Perspective. DTAB Meeting January 27, 2011. Courtney C. Harper, Ph.D. Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health Food and Drug Administration courtney.harper@fda.hhs.gov. FDA. FDA.

750 views • 25 slides

Unique Device Identification and HL7 Messages

Unique Device Identification and HL7 Messages. HL7 Working Groups 27 th Annual Plenary Meeting September 2013 Terrie Reed, Associate Director, Informatics Leslie Tompkins, Informatics Staff FDA, Center for Devices & Radiological Health. Types of Medical Devices and Examples.

402 views • 23 slides

Unique Device Identification and HL7 Messages

Unique Device Identification and HL7 Messages. HL7 Working Groups 27 th Annual Plenary Meeting September 2013 Terrie Reed, Associate Director, Informatics Leslie Tompkins, Informatics Staff FDA, Center for Devices & Radiological Health. Types of Medical Devices and Examples.

379 views • 23 slides

SPL: Brand Industry Challenges & Opportunities

340 views • 21 slides

Design Documentation

Design Documentation. Clint Kehres , Brian Krouse , Jenn Shafner. DHF- design history file 1 . Not all national regulators are equal. Diligent records at every step. Legal Requirements. Maintain knowledge base of the product design. DHF owner = Company, not individual.

354 views • 19 slides