[Title 21 CFR 812.7]
[Code of Federal Regulations (annual edition) - April 1, 1999 Edition]
[Title 21 - FOOD AND DRUGS]
[Chapter I - FOOD AND DRUG ADMINISTRATION,]
[Subchapter H - MEDICAL DEVICES]
[Part 812 - INVESTIGATIONAL DEVICE EXEMPTIONS]
[Subpart A - General Provisions]
[Sec. 812.7 - Prohibition of promotion and other practices.]
[From the U.S. Government Printing Office]


21FOOD AND DRUGS81999-04-011999-04-01false812.7Sec. 812.7FOOD AND DRUGSFOOD AND DRUG ADMINISTRATION,MEDICAL DEVICESINVESTIGATIONAL DEVICE EXEMPTIONSGeneral Provisions
Sec. 812.7  Prohibition of promotion and other practices.

    A sponsor, investigator, or any person acting for or on behalf of a 
sponsor or investigator shall not:
    (a) Promote or test market an investigational device, until after 
FDA has approved the device for commercial distribution.
    (b) Commercialize an investigational device by charging the subjects 
or investigators for a device a price larger than that necessary to 
recover costs of manufacture, research, development, and handling.
    (c) Unduly prolong an investigation. If data developed by the 
investigation indicate in the case of a class III device that premarket 
approval cannot be justified or in the case of a class II device that it 
will not comply with an applicable performance standard or an amendment 
to that standard, the sponsor shall promptly terminate the 
investigation.
    (d) Represent that an investigational device is safe or effective 
for the purposes for which it is being investigated.