[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: 21CFR814.9]

[Page 131-132]
 
                        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 A_General
 
Sec. 814.9  Confidentiality of data and information in a premarket approval 
application (PMA) file.

    (a) A ``PMA file'' includes all data and information submitted with 
or incorporated by reference in the PMA, any IDE incorporated into the 
PMA, any PMA supplement, any report under Sec. 814.82, any master file, 
or any other related submission. Any record in the PMA file will be 
available for public disclosure in accordance with the provisions of 
this section and part 20. The confidentiality of information in a color 
additive petition submitted as part of a PMA is governed by Sec. 71.15.
    (b) The existence of a PMA file may not be disclosed by FDA before 
an approval order is issued to the applicant unless it previously has 
been publicly disclosed or acknowledged.
    (c) If the existence of a PMA file has not been publicly disclosed 
or acknowledged, data or information in the PMA file are not available 
for public disclosure.
    (d)(1) If the existence of a PMA file has been publicly disclosed or 
acknowledged before an order approving, or an order denying approval of 
the PMA is issued, data or information contained in the file are not 
available for public disclosure before such order issues. FDA may, 
however, disclose a summary of portions of the safety and effectiveness 
data before an approval order or an order denying approval of the PMA 
issues if disclosure is relevant to public consideration of a specific 
pending issue.
    (2) Notwithstanding paragraph (d)(1) of this section, FDA will make 
available to the public upon request the information in the IDE that was 
required to be filed in Docket Number 95S-0158 in the Division of 
Dockets Management (HFA-305), Food and Drug Administration, 12420 
Parklawn Dr., rm. 1-23, Rockville, MD 20857, for investigations 
involving an exception from informed consent under Sec. 50.24 of this 
chapter. Persons wishing to request this information shall submit a 
request under the Freedom of Information Act.
    (e) Upon issuance of an order approving, or an order denying 
approval of any PMA, FDA will make available to the public the fact of 
the existence of the PMA and a detailed summary of information submitted 
to FDA respecting the safety and effectiveness of the device that is the 
subject of the PMA and that is the basis for the order.
    (f) After FDA issues an order approving, or an order denying 
approval of any PMA, the following data and information in the PMA file 
are immediately available for public disclosure:
    (1) All safety and effectiveness data and information previously 
disclosed to

[[Page 132]]

the public, as such disclosure is defined in Sec. 20.81.
    (2) Any protocol for a test or study unless the protocol is shown to 
constitute trade secret or confidential commercial or financial 
information under Sec. 20.61.
    (3) Any adverse reaction report, product experience report, consumer 
complaint, and other similar data and information, after deletion of:
    (i) Any information that constitutes trade secret or confidential 
commercial or financial information under Sec. 20.61; and
    (ii) Any personnel, medical, and similar information disclosure of 
which would constitute a clearly unwarranted invasion of personal 
privacy under Sec. 20.63; provided, however, that except for the 
information that constitutes trade secret or confidential commercial or 
financial information under Sec. 20.61, FDA will disclose to a patient 
who requests a report all the information in the report concerning that 
patient.
    (4) A list of components previously disclosed to the public, as such 
disclosure is defined in Sec. 20.81.
    (5) An assay method or other analytical method, unless it does not 
serve any regulatory purpose and is shown to fall within the exemption 
in Sec. 20.61 for trade secret or confidential commercial or financial 
information.
    (6) All correspondence and written summaries of oral discussions 
relating to the PMA file, in accordance with the provisions of 
Sec. Sec. 20.103 and 20.104.
    (g) All safety and effectiveness data and other information not 
previously disclosed to the public are available for public disclosure 
if any one of the following events occurs and the data and information 
do not constitute trade secret or confidential commercial or financial 
information under Sec. 20.61:
    (1) The PMA has been abandoned. FDA will consider a PMA abandoned 
if:
    (i)(A) The applicant fails to respond to a request for additional 
information within 180 days after the date FDA issues the request or
    (B) Other circumstances indicate that further work is not being 
undertaken with respect to it, and
    (ii) The applicant fails to communicate with FDA within 7 days after 
the date on which FDA notifies the applicant that the PMA appears to 
have been abandoned.
    (2) An order denying approval of the PMA has issued, and all legal 
appeals have been exhausted.
    (3) An order withdrawing approval of the PMA has issued, and all 
legal appeals have been exhausted.
    (4) The device has been reclassified.
    (5) The device has been found to be substantially equivalent to a 
class I or class II device.
    (6) The PMA is considered voluntarily withdrawn under Sec. 
814.44(g).
    (h) The following data and information in a PMA file are not 
available for public disclosure unless they have been previously 
disclosed to the public, as such disclosure is defined in Sec. 20.81, 
or they relate to a device for which a PMA has been abandoned and they 
no longer represent a trade secret or confidential commercial or 
financial information as defined in Sec. 20.61:
    (1) Manufacturing methods or processes, including quality control 
procedures.
    (2) Production, sales, distribution, and similar data and 
information, except that any compilation of such data and information 
aggregated and prepared in a way that does not reveal data or 
information which are not available for public disclosure under this 
provision is available for public disclosure.
    (3) Quantitative or semiquantitative formulas.

[51 FR 26364, July 22, 1986, as amended at 61 FR 51531, Oct. 2, 1996]