![]() ![]() IVD Home Use Lab Tests (Over The Counter) Tests More about Humanitarian Device Exemption (HDE) Searchable listing of Humanitarian Device Exemption (HDE) Class III medical devices. searches the following databases: Premarket Notifications (510(k)s) and Premarket Approvals (PMA).Ī searchable listing by state and zip code of all mammography facilities certified by the Food and Drug Administration (FDA) as meeting baseline quality standards for equipment, personnel and practices under the Mammography Quality Standards Act of 1992 (MQSA). It includes links to the device summary information, manufacturer, approval date, user instructions, and other consumer information. This database contains de novo classification is a catalog of cleared and approved medical device information from FDA. CLIA waived test systems are waived from certain CLIA laboratory requirements (42 CFR Part 493).ĭe novo provides a possible route to classify novel devices of low to moderate risk. This database contains the commercially marketed in vitro test systems categorized as CLIA waived by the FDA since January 31, 2000, and by the Centers for Disease Control and Prevention (CDC) prior to that date. This database contains the commercially marketed in vitro test systems categorized by the FDA since January 31, 2000, and tests categorized by the Centers for Disease Control and Prevention (CDC) prior to that date.Ĭlinical Laboratory Improvement Amendments - Download Data This database contains the most recent revision from the Government Printing Office (GPO) of the Code of Federal Regulations (CFR) Title 21 - Food and Drugs.Ĭlinical Laboratory Improvement Amendments (CLIA) This searchable database contains valid (not expired) export certificates submitted electronically via CECATS (CDRH Export Certification Application and Tracking System) and issued by the Center for Devices and Radiological Health. The results displayed include the facility name, certificate type, expiration date, certificate number, and the number of pages per certificate. This database contains historical information about CDRH Advisory Committees and Panel meetings through 2008, including summaries and transcripts.įDA Advisory Committees and Meeting MaterialsĬDRH Export Certificate Validation (CECV) This database contains key device identification information submitted to the FDA about medical devices that have Unique Device Identifiers (UDI). This database allows you to search 522 information by manufacturer or device information.ĪccessGUDID (Global Unique Device Identification Database) This database contains information about current 522 Postmarket Surveillance Studies. ![]() 522 Postmarket Surveillance Studies Program
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