[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR814.44]

[Page 126-128]
 
                        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 C--FDA Action on a PMA
 
Sec. 814.44  Procedures for review of a PMA.

    (a) FDA will begin substantive review of a PMA after the PMA is 
accepted for filing under Sec. 814.42. FDA may refer the PMA to a panel 
on its own initiative, and will do so upon request of an applicant, 
unless FDA determines that the application substantially duplicates 
information previously reviewed by a panel. If FDA refers an application 
to a panel, FDA will forward the PMA, or relevant portions thereof, to 
each member of the appropriate FDA panel for review. During the review 
process, FDA may communicate with the applicant as set forth under 
Sec. 814.37(b), or with a panel to respond to questions that may be 
posed by panel members or to provide additional information to the 
panel. FDA will maintain a record of all communications with the 
applicant and with the panel.
    (b) The advisory committee shall submit a report to FDA which 
includes the committee's recommendation and the basis for such 
recommendation on the PMA. Before submission of this report, the 
committee shall hold a public meeting to review the PMA in accordance 
with part 14. This meeting may be held by a telephone conference under 
Sec. 14.22(g). The advisory committee report and recommendation may be 
in the form of a meeting transcript signed by the chairperson of the 
committee.
    (c) FDA will complete its review of the PMA and the advisory 
committee report and recommendation and, within the later of 180 days 
from the date of filing of the PMA under Sec. 814.42 or the number of 
days after the date of filing as determined under Sec. 814.37(c), issue 
an approval order under paragraph (d) of this section, an approvable 
letter under paragraph (e) of this section, a not approvable letter 
under paragraph (f) of this section, or an order denying approval of the 
application under Sec. 814.45(a).
    (d)(1) FDA will issue to the applicant an order approving a PMA if 
none of

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the reasons in Sec. 814.45 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. FDA will 
also give the public notice of the order, including notice of and 
opportunity for any interested persons to request review under section 
515(d)(3) of the act. The notice of approval will be placed on FDA's 
home page on the Internet (http://www.fda.gov), and it will state that a 
detailed summary of information respecting the safety and effectiveness 
of the device, which was the basis for the order approving the PMA, 
including information about any adverse effects of the device on health, 
is available on the Internet and has been placed on public display, and 
that copies are available upon request. FDA will publish in the Federal 
Register after each quarter a list of the approvals announced in that 
quarter. When a notice of approval is published, data and information in 
the PMA file will be available for public disclosure in accordance with 
Sec. 814.9.
    (2) A request for copies of the current PMA approvals and denials 
document and for copies of summaries of safety and effectiveness shall 
be sent in writing to the Dockets Management Branch (HFA-305), Food and 
Drug Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857.
    (e) FDA will send the applicant an approvable letter if the 
application substantially meets the requirements of this part and the 
agency believes it can approve the application if specific additional 
information is submitted or specific conditions are agreed to by the 
applicant.
    (1) 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:
    (i) The submission of certain information identified in the 
approvable letter, e.g., final labeling;
    (ii) An FDA inspection that finds the manufacturing facilities, 
methods, and controls in compliance with part 820 and, if applicable, 
that verifies records pertinent to the PMA;
    (iii) Restrictions imposed on the device under section 
515(d)(1)(B)(ii) or 520(e) of the act;
    (iv) Postapproval requirements as described in subpart E of this 
part.
    (2) In response to an approvable letter the applicant may:
    (i) Amend the PMA as requested in the approvable letter; or
    (ii) Consider the approvable letter to be a denial of approval of 
the PMA under Sec. 814.45 and request administrative review under 
section 515(d)(3) of the act by filing a petition in the form of a 
petition for reconsideration under Sec. 10.33; or
    (iii) Withdraw the PMA.
    (f) 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. 814.45(a). The not approvable letter will 
describe the deficiencies in the application, including each applicable 
ground for denial under section 515(d)(2) (A)-(E) of the act, and, where 
practical, will identify measures required to place the PMA in 
approvable form. In response to a not approvable letter, the applicant 
may:
    (1) Amend the PMA as requested in the not approvable letter (such an 
amendment will be considered a major amendment under Sec. 814.37(c)(1)); 
or
    (2) Consider the not approvable letter to be a denial of approval of 
the PMA under Sec. 814.45 and request administrative review under 
section 515(d)(3) of the act by filing a petition in the form of a 
petition for reconsideration under Sec. 10.33; or
    (3) Withdraw the PMA.
    (g) FDA will consider a PMA to have been withdrawn voluntarily if:
    (1) The applicant fails to respond in writing to a written request 
for an amendment within 180 days after the date FDA issues such request;

[[Page 128]]

    (2) The applicant fails to respond in writing to an approvable or 
not approvable letter within 180 days after the date FDA issues such 
letter; or
    (3) The applicant submits a written notice to FDA that the PMA has 
been withdrawn.

[51 FR 26364, July 22, 1986, as amended at 57 FR 58403, Dec. 10, 1992; 
63 FR 4572, Jan. 30, 1998]