An overview of FDA medical device regulation as it relates to deep brain stimulation devices

IEEE Transactions on Neural Systems and Rehabilitation Engineering

Volumn 15, Issue 3, 2007, Pages 421-424

  Peña, Carlos ^a   Bowsher, Kristen ^b   Costello, Ann ^b   De Luca, Robert ^b   Doll, Sara ^b   Li, Khan ^c   Schroeder, Marie ^b   Stevens, Theodore ^b  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^b CENTER FOR DEVICES AND RADIOLOGICAL HEALTH   (United States)

^c JOHNS HOPKINS UNIVERSITY   (United States)

Author keywords

Deep brain stimulation (DBS); Food and Drug Administration (FDA); Medical devices

Indexed keywords

BRAIN; MARKETING; NEUROLOGY; RADIOLOGY; REGULATORY COMPLIANCE; BIOMEDICAL ENGINEERING; DRUG PRODUCTS;

DEEP BRAIN STIMULATION (DBS); FOOD AND DRUG ADMINISTRATION (FDA); POSTMARKET REQUIREMENTS;

BIOMEDICAL EQUIPMENT; NEUROSURGERY;

BRAIN DEPTH STIMULATION; CLINICAL STUDY; FOOD AND DRUG ADMINISTRATION; HUMAN; MEDICAL INSTRUMENTATION; PATIENT SAFETY; PRIORITY JOURNAL; REVIEW; RISK ASSESSMENT; TREATMENT INDICATION;

DEEP BRAIN STIMULATION; DEVICE APPROVAL; GUIDELINES; PRODUCT SURVEILLANCE, POSTMARKETING; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

CLINICAL STUDY; DEEP BRAIN STIMULATION; FOOD AND DRUG ADMINISTRATION; MARKETING APPLICATION; MEDICAL DEVICES; MEDICAL PRODUCTS;

EID: 77955067527     PISSN: 15344320     EISSN: None     Source Type: Journal    
DOI: 10.1109/TNSRE.2007.903973     Document Type: Review

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