[Federal Register Volume 75, Number 227 (Friday, November 26, 2010)]
[Pages 72829-72830]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-29731]



Food and Drug Administration

[Docket Nos. FDA-2010-M-0402, FDA-2010-M-0361, and FDA-2010-M-0519]

Medical Devices; Availability of Safety and Effectiveness 
Summaries for Premarket Approval Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


SUMMARY: The Food and Drug Administration (FDA) is publishing a list of 
premarket approval applications (PMAs) that have been approved. This 
list is intended to inform the public of the availability of safety and 
effectiveness summaries of approved PMAs through the Internet and the 
Agency's Division of Dockets Management.

ADDRESSES: Submit written requests for copies of summaries of safety 
and effectiveness data to the Division of Dockets Management (HFA-305), 
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, 
MD 20852. Please cite the appropriate docket number as listed in table 
1 of this document when submitting a written request. See the 
SUPPLEMENTARY INFORMATION section for electronic access to the 
summaries of safety and effectiveness.

FOR FURTHER INFORMATION CONTACT: Nicole Wolanski, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, rm. 1650, Silver Spring, MD 20993-0002, 301-


I. Background

    In the Federal Register of January 30, 1998 (63 FR 4571), FDA 
published a final rule that revised 21 CFR 814.44(d) and 814.45(d) to 
discontinue individual publication of PMA approvals and denials in the 
Federal Register. Instead, the Agency now posts this information on the 
Internet on FDA's home page at http://www.fda.gov. FDA believes that 
this procedure expedites public notification of these actions because 
announcements can be placed on the Internet more quickly than they can 
be published in the Federal Register, and FDA believes that the 
Internet is accessible to more people than the Federal Register.
    In accordance with section 515(d)(4) and (e)(2) of the Federal 
Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360e(d)(4) and 
(e)(2)), notification of an order approving, denying, or withdrawing 
approval of a PMA will continue to include a notice of opportunity to 
request review of the order under section 515(g) of the FD&C Act. The 
30-day period for requesting reconsideration of an FDA action under 
Sec.  10.33(b) (21 CFR 10.33(b)) for notices announcing approval of a 
PMA begins on the day the notice is placed on the Internet. Section 
10.33(b) provides that FDA may, for good cause, extend this 30-day 
period. Reconsideration of a denial or withdrawal of approval of a PMA 
may be sought only by the applicant; in these cases, the 30-day period 
will begin when the applicant is notified by FDA in writing of its 
    The regulations provide that FDA publish a quarterly list of 

[[Page 72830]]

safety and effectiveness summaries of PMA approvals and denials that 
were announced during that quarter. The following is a list of approved 
PMAs for which summaries of safety and effectiveness were placed on the 
Internet from July 1, 2010, through September 30, 2010. There were no 
denial actions during this period. The list provides the manufacturer's 
name, the product's generic name or the trade name, and the approval 

 Table 1--List of Safety and Effectiveness Summaries for Approved PMAs Made Available From July 1, 2010, Through
                                               September 30, 2010
        PMA No. Docket No.                 Applicant                Trade name               Approval date
P080027, FDA-2010-M-0402.........  OraSure Technologies,     ORAQUICK HCV RAPID        June 25, 2010.
                                    Inc.                      ANTIBODY TEST.
P050034, FDA-2010-M-0361.........  Vision Care Ophthalmic    IMPLANTABLE MINIATURE     July 1, 2010.
                                    Technologies, Ltd.        TELESCOPE.
P080026, FDA-2010-M-0519.........  Abbott Molecular, Inc...  ABBOTT REALTIME HBV       August 13, 2010.

II. Electronic Access

    Persons with access to the Internet may obtain the documents at 

    Dated: November 18, 2010.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2010-29731 Filed 11-24-10; 8:45 am]