|
Accession Number
|
AVA16607-VNB1
|
|
Title
|
Statistical Aspects of Submission to FDA: A Medical Device Perspective.
|
|
Publication Date
|
1994
|
|
Media Count
|
1AV-VHS 1/2 inch - 1 cassette
|
|
Personal Author
|
N/A
|
|
Abstract
|
This program discusses submissions to the Food and Drug Administration for Class III medical devices and includes a description of data required to demonstrate evidence of effectiveness and evidence of safety.
|
|
Keywords
|
Audiovisual aids
Class III medical devices
Effectiveness
Equipment safety
Medical devices
Medical equipment
Safety
Statistical data
|
|
|
Source Agency
|
Office of Communication Media Center for Devices and Radiological Health - FDA - Audiovisual
|
|
NTIS Subject Category
|
95C - Biomedical Instrumentation & Bioengineering
92D - Education, Law, & Humanities
|
|
Corporate Author
|
Food and Drug Administration, Rockville, MD. Office of Communication Media Center for Devices and Radiological Health.
|
|
Document Type
|
Audiovisual
|
|
Title Note
|
N/A
|
|
NTIS Issue Number
|
0003
|
|
Contract Number
|
N/A
|
