DOPATREE
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DOPATREE
ORGANIZATIONS
GOVERNMENT ORGANIZATIONS-ALL (GOVT, GOV’T)
UNITED STATES GOVERNMENT ORGANIZATIONS / LISTINGS
US FOOD AND DRUG ADMINISTRATION (FDA)
US FOOD AND DRUG ADMINISTRATION / LISTINGS
US CENTER FOR DEVICES AND RADIOLOGICAL HEALTH (CDRH)
US FDA CDRH / RELATED
MEDICAL DEVICES-ALL (ALL MEDICAL DEVICES, 513G, 513(G), MULTIPLE DEVICES, SINGLE FUNCTION, EQUIPMENT, CLASS I, II, III, 515(B), 515B, MANUFACTURERS, GENERAL)
MEDICAL DEVICES / DATABASES / US
Parents
MEDICAL DEVICES-ALL (ALL MEDICAL DEVICES, 513G, 513(G), MULTIPLE DEVICES, SINGLE FUNCTION, EQUIPMENT, CLASS I, II, III, 515(B), 515B, MANUFACTURERS, GENERAL)
Children
US FDA. 522 POSTMARKET SURVEILLANCE STUDIES DATABASE. ACCESSED : MAR 23, 2022.
US FDA. CDRH ADVISORY MEETING MATERIALS ARCHIVE. ACCESSED : MAR 23, 2022.
US FDA. CDRH FOIA ELECTRONIC READING ROOM. ACCESSED : MAR 23, 2022.
US FDA. CFR - CODE OF FEDERAL REGULATIONS TITLE 21. (MEDICAL DEVICES ONLY) ACCESSED : JAN 3, 2022.
US FDA. CLIA - CLINICAL LABORATORY IMPROVEMENT AMENDMENTS - CURRENTLY WAIVED ANALYTES. ACCESSED : MAR 23, 2022.
US FDA. CLIA - CLINICAL LABORATORY IMPROVEMENT AMENDMENTS. ACCESSED : MAR 23, 2022.
US FDA. DEVICE CLASSIFICATION UNDER SECTION 513(F)(2)(DE NOVO). ACCESSED : MAR 23, 2022.
US FDA. ESTABLISHMENT REGISTRATION & DEVICE LISTING. ACCESSED : MAR 23, 2022.
US FDA. GUIDANCE. 510(K) PREMARKET NOTIFICATION. ACCESSED : MAR 23, 2022.
US FDA. HUMANITARIAN DEVICE EXEMPTION (HDE). ACCESSED : MAR 23, 2022.
US FDA. MAMMOGRAPHY FACILITIES. ACCESSED : MAR 23, 2022.
US FDA. MAUDE - MANUFACTURER AND USER FACILITY DEVICE EXPERIENCE. MAR 23, 2022.
US FDA. MDR DATABASE SEARCH. ACCESSED : MAR 23, 2022.
US FDA. MEDICAL DEVICE RECALLS. ACCESSED : MAR 23, 2022.
US FDA. MEDSUN REPORTS. ACCESSED : MAR 23, 2022.
US FDA. POST-APPROVAL STUDIES (PAS) DATABASE. ACCESSED : MAR 23, 2022.
US FDA. PREMARKET APPROVAL (PMA) SUMMARY REVIEW MEMOS FOR 180-DAY DESIGN CHANGES. ACCESSED : MAR 23, 2022.
US FDA. PREMARKET APPROVAL (PMA). ACCESSED : MAR 23. 2022.
US FDA. PRODUCT CLASSIFICATION. ACCESSED : MAR 23, 2022.
US FDA. RADIATION EMITTING ELECTRONIC PRODUCT CODES. ACCESSED : MAR 23, 2022.
US FDA. RADIATION-EMITTING ELECTRONIC PRODUCTS CORRECTIVE ACTIONS. ACCESSED : MAR 23, 2022.
US FDA. RECOGNIZED CONSENSUS STANDARDS. ACCESSED : MAR 23, 2022.
US FDA. SEARCH FOR FDA GUIDANCE DOCUMENTS. ACCESSED : MAR 23, 2022.
US FDA. TPLC - TOTAL PRODUCT LIFE CYCLE. ACCESSED : MAR 23 2022.
US NIH-NATIONAL LIBRARY OF MEDICINE. ACCESS GLOBAL UNIQUE DEVICE IDENTIFICATION DATABASE (GUDID). ACCESSED : MAR 23, 2022.