[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR812.30]

[Page 104]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 812--INVESTIGATIONAL DEVICE EXEMPTIONS--Table of Contents
 
            Subpart B--Application and Administrative Action
 
Sec. 812.30  FDA action on applications.

    (a) Approval or disapproval. FDA will notify the sponsor in writing 
of the date it receives an application. FDA may approve an investigation 
as proposed, approve it with modifications, or disapprove it. An 
investigation may not begin until:
    (1) Thirty days after FDA receives the application at the address in 
Sec. 812.19 for the investigation of a device other than a banned 
device, unless FDA notifies the sponsor that the investigation may not 
begin; or
    (2) FDA approves, by order, an IDE for the investigation.
    (b) Grounds for disapproval or withdrawal. FDA may disapprove or 
withdraw approval of an application if FDA finds that:
    (1) There has been a failure to comply with any requirement of this 
part or the act, any other applicable regulation or statute, or any 
condition of approval imposed by an IRB or FDA.
    (2) The application or a report contains an untrue statement of a 
material fact, or omits material information required by this part.
    (3) The sponsor fails to respond to a request for additional 
information within the time prescribed by FDA.
    (4) There is reason to believe that the risks to the subjects are 
not outweighed by the anticipated benefits to the subjects and the 
importance of the knowledge to be gained, or informed consent is 
inadquate, or the investigation is scientifically unsound, or there is 
reason to believe that the device as used is ineffective.
    (5) It is otherwise unreasonable to begin or to continue the 
investigation owing to the way in which the device is used or the 
inadequacy of:
    (i) The report of prior investigations or the investigational plan;
    (ii) The methods, facilities, and controls used for the 
manufacturing, processing, packaging, storage, and, where appropriate, 
installation of the device; or
    (iii) Monitoring and review of the investigation.
    (c) Notice of disapproval or withdrawal. If FDA disapproves an 
application or proposes to withdraw approval of an application, FDA will 
notify the sponsor in writing.
    (1) A disapproval order will contain a complete statement of the 
reasons for disapproval and a statement that the sponsor has an 
opportunity to request a hearing under part 16.
    (2) A notice of a proposed withdrawal of approval will contain a 
complete statement of the reasons for withdrawal and a statement that 
the sponsor has an opportunity to request a hearing under part 16. FDA 
will provide the opportunity for hearing before withdrawal of approval, 
unless FDA determines in the notice that continuation of testing under 
the exemption will result in an unreasonble risk to the public health 
and orders withdrawal of approval before any hearing.

[45 FR 3751, Jan. 18, 1980, as amended at 45 FR 58842, Sept. 5, 1980]

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