[Federal Register Volume 79, Number 111 (Tuesday, June 10, 2014)]
[Notices]
[Page 33203]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-13565]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-P-1107]


OXIPLEX/SP Gel; FzioMed, Incorporated's Petition for Review of 
the Food and Drug Administration's Denial of Premarket Approval; Notice 
of Meeting Cancellation

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The meeting of the Medical Devices Dispute Resolution Panel 
scheduled for June 10, 2014, is cancelled. This meeting was announced 
in the Federal Register of May 14, 2014.

FOR FURTHER INFORMATION CONTACT: Pamela D. Scott, Center for Devices 
and Radiological Health, 10903 New Hampshire Ave., Bldg. 66, Rm. 3611, 
Silver Spring, MD 20993-0002, 301-796-5433, FAX: 301-847-8510, email: 
[email protected].

SUPPLEMENTARY INFORMATION: The meeting of the Medical Devices Dispute 
Resolution Panel (the panel) of the Medical Devices Advisory Committee 
scheduled for June 10, 2014, is cancelled. On June 10, 2014, the panel 
was slated to discuss the Center for Device and Radiological Health's 
(CDRH's) denial of a premarket approval application (PMA) for OXIPLEX 
submitted by FzioMed, the sponsor for OXIPLEX.
    On August 21, 2007, FzioMed submitted a PMA (PMA P070023) for 
OXIPLEX. OXIPLEX is an absorbable, clear, viscoelastic gel designed to 
be applied in the lower back during lumbar spine surgery. The device's 
proposed indication is for use as a surgical adjuvant in adult patients 
with primary leg pain and severe baseline back pain undergoing first 
surgical intervention (i.e., open or endoscopic posterior lumbar 
laminectomy, laminotomy, or discectomy) for diagnosed unilateral 
herniation of lumbar intervertebral disc material associated with 
radiculopathy. The proposed intended use is for one-time use, up to 3 
milliliters, after hemostasis during wound closure, as an adjunct to 
primary surgical intervention to improve patient outcomes by reducing 
leg pain, back pain, and neurologic symptoms.
    On October 9, 2012, CDRH issued a decision upholding a not 
approvable letter in response to the PMA P070023 for OXIPLEX. CDRH 
determined that PMA P070023 is not approvable based on its conclusion 
that the data and information offered in support of the PMA do not 
provide a reasonable assurance that the device is safe and effective 
under the conditions of use prescribed, recommended, or suggested in 
the proposed labeling, as required by section 515(d)(2) of the Federal 
Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360e(d)(2)).
    On November 5, 2012, FzioMed requested administrative review of 
CDRH's decision to uphold its not approvable letter. Submitted in the 
form of a petition for reconsideration under 21 CFR 10.33 (see Sec.  
814.44(f)(2) (21 CFR 814.44(f)(2)), FzioMed's petition for review 
(petition) stated that, in accordance with Sec.  814.44(f), FzioMed 
considered the decision to uphold the not approvable letter to be a 
denial of approval of PMA P070023 under Sec.  814.45). Under section 
515(d)(4) of the FD&C Act, FzioMed requested review of this denial 
under section 515(g)(2) of the FD&C Act.
    Accordingly, as required by Sec.  814.45(e)(3), CDRH issued an 
order denying approval of the PMA for OXIPLEX on October 21, 2013. 
Under section 515(g)(2) of the FD&C Act, on October 25, 2013, FDA 
granted FzioMed's petition for review of the order denying PMA P070023. 
In the Federal Register of May 14, 2014 (79 FR 27623), the Office of 
the Commissioner referred PMA P070023 and the basis for the order 
denying its approval to the Medical Devices Dispute Resolution Panel, 
and announced that the panel was scheduled to meet to discuss the 
clinical and scientific issues raised by CDRH's Denial Order on June 
10, 2014.
    Since the panel meeting announcement on May 14, 2014, the parties 
have agreed that the panel meeting should not go forward on June 10, 
2014. The Agency is thereby cancelling the June 10, 2014, meeting.

    Dated: June 5, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-13565 Filed 6-6-14; 11:15 am]
BILLING CODE 4164-01-P