non-contacting devices / product development protocol / sharpened metal blade / risk devices / to their device / low risk devices / contact lens disinfecting solution / immunoassay technology / manufacturing practice requirements / metal alloy / Web/CDRH home page / marketed predicate devices / manufacturing practice / marketed predicate device / manual device / higher risk devices / marketed devices / amplification technology / Energy type / fundamental scientific technology / preamendments devices / device manufacturer / marketed device / /
MedicalCondition
injury / illness / /
MedicalTreatment
catheter / /
Organization
National Committee of Clinical Laboratory Standards / U.S DEPARTMENT OF HEALTH AND HUMAN SERVICES / Congress / Food and Drug Administration / Center for Devices and Radiological Health / United States Congress / office of Device Evaluation / FDA / Food and Drug Administration Center for Devices and Radiological Health Rockville / Food and Drug Law Institute / Document Mail Center / PMAs / /
Person
Silver Spring / Heather Rosecrans / / /
Position
President of the United States / /
ProvinceOrState
Maryland / /
Technology
laser / amplification technology / Fundamental Scientific Technology / immunoassay technology / hybridization / product development protocol / /
The New 510(k) Paradigm Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications