The FDA's role in medical device clinical studies of human subjects

Journal of Neural Engineering

Volumn 2, Issue 1, 2005, Pages

  Saviola, James ^a  

^a Office of Device Evaluation   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DATA ACQUISITION; PRODUCT DESIGN; PROJECT MANAGEMENT; PROSTHETICS;

FOOD AND DRUG ADMINISTRATION'S (FDA); MEDICAL DEVICES; PROSTHETIC DEVICES;

BIOMEDICAL ENGINEERING;

CONFERENCE PAPER; EVIDENCE BASED MEDICINE; FOOD AND DRUG ADMINISTRATION; GOVERNMENT REGULATION; HUMAN; HUMAN RIGHTS; INFORMED CONSENT; MEDICAL INSTRUMENTATION; METHODOLOGY; PATIENT PARTICIPATION; PRIORITY JOURNAL; SAFETY; VISUAL PROSTHESIS; CLINICAL TRIAL; HUMAN EXPERIMENT; LEGAL ASPECT; ORGANIZATION AND MANAGEMENT; PRACTICE GUIDELINE; PROSTHESES AND ORTHOSES; RETINA DISEASE; REVIEW; STANDARD; UNITED STATES;

CLINICAL TRIALS; DEVICE APPROVAL; GOVERNMENT REGULATION; GUIDELINES; HUMANS; PROSTHESES AND IMPLANTS; RETINAL DISEASES; THERAPEUTIC HUMAN EXPERIMENTATION; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 22044438947     PISSN: 17412560     EISSN: None     Source Type: Journal    
DOI: 10.1088/1741-2560/2/1/001     Document Type: Conference Paper

References (5)

1. CDRH Device Advice: http://www.fda.gov/cdrh/devadvice/
2. Code of Federal Regulations, Office of the Federal Register, National Archives and Records Administration, Washington, DC (Government Printing Office web site) http://www.access.gpo.gov/nara/cfr/cfr-table-search.html
3. Federal Food, Drug, and Cosmetic Act with portions revised or new - as amended by the FDA Modernization Act of 1997 (FDA web site) Available at: http://www.fda.gov/opacom/laws/fdcact/fdctoc.htm
4. IDE Manual www.fda.gov/cdrh/manual/idemanul.html
5. IDE Policies and Procedures Guidance www.fda.gov/cdrh/ode/idepolcy.html