[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2005]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR814.116]

[Page 148-149]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 814_PREMARKET APPROVAL OF MEDICAL DEVICES--Table of Contents
 
                   Subpart H_Humanitarian Use Devices
 
Sec. 814.116  Procedures for review of an HDE.

    (a) Substantive review. FDA will begin substantive review of an HDE 
after the HDE is accepted for filing under Sec. 814.112. FDA may refer 
an original HDE application to a panel on its own initiative, and shall 
do so upon the request of an applicant, unless FDA determines that the 
application substantially duplicates information previously reviewed by 
a panel. If the HDE is referred to a panel, the agency shall follow the 
procedures set forth under Sec. 814.44, with the exception that FDA 
will complete its review of the HDE and the advisory committee report 
and recommendations within 75 days from receipt of an HDE that is 
accepted for filing under Sec. 814.112 or the date of filing as 
determined under Sec. 814.106, whichever is later. Within the later of 
these two timeframes, FDA will issue an approval order under paragraph 
(b) of this section, an approvable letter under paragraph (c) of this 
section, a not approvable letter under paragraph (d) of this section, or 
an order denying approval of the application under Sec. 814.118(a).
    (b) Approval order. FDA will issue to the applicant an order 
approving an HDE if none of the reasons in Sec. 814.118 for denying 
approval of the application applies. FDA will approve an application on 
the basis of draft final labeling if the only deficiencies in the 
application concern editorial or similar minor deficiencies in the draft 
final labeling. Such approval will be conditioned upon the applicant 
incorporating the specified labeling changes exactly as directed and 
upon the applicant submitting to FDA a copy of the final printed 
labeling before marketing. The notice of approval of an HDE will be 
published in the Federal Register in accordance with the rules and 
policies applicable to PMA's submitted under Sec. 814.20. Following the 
issuance of an approval order, data and information in the HDE file will 
be available for public disclosure in accordance with Sec. 814.9(b) 
through (h), as applicable.
    (c) Approvable letter. FDA will send the applicant an approvable 
letter if the application substantially meets the requirements of this 
subpart and the

[[Page 149]]

agency believes it can approve the application if specific additional 
information is submitted or specific conditions are agreed to by the 
applicant. The approvable letter will describe the information FDA 
requires to be provided by the applicant or the conditions the applicant 
is required to meet to obtain approval. For example, FDA may require as 
a condition to approval:
    (1) The submission of certain information identified in the 
approvable letter, e.g., final labeling;
    (2) Restrictions imposed on the device under section 520(e) of the 
act;
    (3) Postapproval requirements as described in subpart E of this 
part; and
    (4) An FDA inspection that finds the manufacturing facilities, 
methods, and controls in compliance with part 820 of this chapter and, 
if applicable, that verifies records pertinent to the HDE.
    (d) Not approvable letter. FDA will send the applicant a not 
approvable letter if the agency believes that the application may not be 
approved for one or more of the reasons given in Sec. 814.118. The not 
approvable letter will describe the deficiencies in the application and, 
where practical, will identify measures required to place the HDE in 
approvable form. The applicant may respond to the not approvable letter 
in the same manner as permitted for not approvable letters for PMA's 
under Sec. 814.44(f), with the exception that if a major HDE amendment 
is submitted, the review period may be extended up to 75 days.
    (e) FDA will consider an HDE to have been withdrawn voluntarily if:
    (1) The applicant fails to respond in writing to a written request 
for an amendment within 75 days after the date FDA issues such request;
    (2) The applicant fails to respond in writing to an approvable or 
not approvable letter within 75 days after the date FDA issues such 
letter; or
    (3) The applicant submits a written notice to FDA that the HDE has 
been withdrawn.

[61 FR 33244, June 26, 1996, as amended at 63 FR 59221, Nov. 3, 1998]