CDRHNew
Date: April 24, 2013
The following new items were added to the CDRH web pages on April 23, 2013. Previous CDRH New Items can be found on the CDRHNew Page.
- Announcing Medwatcher - a mobile app that allows individuals to submit voluntary reports of serious medical device problems to the FDA using a smart phone or tablet.
- CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel-Influenza A/H7 (Eurasian Lineage) Assay - Letter of Authorization, Fact Sheets for Healthcare Providers and Patients, and Labeling
- Device Postmarket Surveillance
- FDA Wants You (to Get Involved)
- Class I Medical Device Recall: LifeScan, Inc., OneTouch Verio IQ Blood Glucose Meter
- Meeting materials posted for April 25, 2013 Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee meeting
- Federal Register: Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Investigational Device Exemptions Reports and Records
- Federal Register: Pilot Program for Early Feasibility Study Investigational Device Exemption Applications; Extending the Duration of the Program
- Federal Register: Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing'; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
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