[Federal Register Volume 76, Number 233 (Monday, December 5, 2011)]
[Notices]
[Page 75887]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-31105]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-P-0176]
SEDASYS Computer-Assisted Personalized Sedation System; Ethicon
Endo-Surgery, Incorporated's Petition for Review of the Food and Drug
Administration's Denial of Premarket Approval; Notice of Cancellation
of Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The meeting of the Medical Devices Dispute Resolution Panel
scheduled for December 14, 2011, is cancelled. This meeting was
announced in the Federal Register of November 21, 2011 (76 FR 71980).
FOR FURTHER INFORMATION CONTACT: Nancy Braier, Center for Devices and
Radiological Health, 10903 New Hampshire Ave., Bldg. 66, rm. 5454,
Silver Spring, MD 20993-0002, (301) 796-5676, FAX: (301) 847-8510,
email: [email protected].
SUPPLEMENTARY INFORMATION:
Background
The meeting of the Medical Devices Dispute Resolution Panel of the
Medical Devices Advisory Committee scheduled for December 14, 2011, is
cancelled. On December 14, 2011, this advisory committee was slated to
discuss the Center for Devices and Radiological Health's (CDRH's)
denial of a premarket approval application (PMA) for the SEDASYS
computer-assisted personalized sedation system (SEDASYS) submitted by
Ethicon Endo-Surgery Inc. (EES), the sponsor for SEDASYS. This meeting
has been cancelled because EES has withdrawn its petition for review of
this denial.
On February 26, 2010, CDRH issued a letter to EES indicating that
PMA P080009 for SEDASYS was not approvable under Sec. 814.44(f) (21
CFR 814.44(f)) because CDRH concluded that the data and information
offered in support of the PMA did not provide a reasonable assurance
that the device is safe under the conditions of use prescribed,
recommended, or suggested in the proposed labeling, as required by
section 515(d)(2)(A) of the Federal Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 360e(d)(2)(A)).
On March 25, 2010, EES requested review of the not approvable
letter. Submitted in the form of a petition for reconsideration under
21 CFR 10.33 (see 21 CFR 814.44(f)(2)), EES's petition stated that, in
accordance with Sec. 814.44(f), EES considered the not approvable
letter to be a denial of approval of PMA P080009 under Sec. 814.45 (21
CFR 814.45). In accordance with section 515(d)(4) of the FD&C Act, EES
requested review of this denial under section 515(g)(2) of the FD&C
Act. Subsequently, on October 26, 2010, CDRH issued an order denying
approval of the SEDASYS PMA (Denial Order), as required by Sec.
814.45(e)(3). On November 5, 2010, in accordance with section 515(g)(2)
of the FD&C Act, FDA granted EES's petition for review of the Denial
Order.
FDA's Office of the Commissioner (OC) referred PMA P080009 and the
basis for CDRH's Denial Order to the Medical Devices Dispute Resolution
Panel of the Medical Devices Advisory Committee, an advisory committee
of experts established, in part, to receive referrals of petitions for
advisory committee review under section 515(g)(2)(B) of the FD&C Act.
(See 76 FR 15321, March 21, 2011.) In the Federal Register of November
21, 2011, FDA announced that this advisory committee was scheduled to
meet to discuss the clinical and scientific issues raised by CDRH's
Denial Order on December 14, 2011.
By letter dated November 28, 2011, EES notified OC that EES
``withdraws its request for administrative review'' of that order
``through an independent advisory committee under Section 515(g)(2) of
the Federal Food, Drug, and Cosmetic Act.'' Because EES has withdrawn
its petition for review of CDRH's denial of approval of the SEDASYS
PMA, OC regards the matter it initiated closed and is, accordingly,
canceling the previously mentioned meeting of the Medical Devices
Dispute Resolution Panel scheduled for December 14, 2011.
Dated: November 30, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-31105 Filed 12-2-11; 8:45 am]
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