[Code of Federal Regulations]

[Title 21, Volume 8]

[Revised as of April 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 21CFR812.30]



[Page 104-105]

 

                        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:



[[Page 105]]



    (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]