[Federal Register Volume 76, Number 54 (Monday, March 21, 2011)]
[Notices]
[Pages 15321-15322]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-6520]
[[Page 15321]]
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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, Inc.'s, Petition for Review of FDA's Denial of Premarket
Approval
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing that it
intends to refer for review before an advisory committee Ethicon Endo-
Surgery Inc.'s (EES's), petition for review of the Agency's denial of
premarket approval for its SEDASYS computer-assisted personalized
sedation system (SEDASYS system).
ADDRESSES: Submissions related to the petition should be filed with the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Tarita Rooths, Regulations, Policy,
and Management Staff, Food and Drug Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993, 301-796-9138.
SUPPLEMENTARY INFORMATION: On February 26, 2010, the Center for Devices
and Radiological Health (CDRH) issued a not approvable letter in
response to the premarket approval application (PMA) (PMA P080009)
submitted by EES for the SEDASYS system. The SEDASYS system is intended
for use by gastroenterologists as a drug-delivery system for the
administration of propofol for minimal-to-moderate sedation in healthy
patients undergoing a colonoscopy or esophagogastroduodenoscopy. CDRH
determined the PMA for the SEDASYS system not to be approvable under
Sec. 814.44(f) (21 CFR 814.44(f)) because it 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).
On March 25, 2010, EES requested administrative review of the not
approvable letter. Submitted in the form of a petition for
reconsideration under 21 CFR 10.33 (see Sec. 814.44(f)(2)), EES's
request 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). Pursuant to section 515(d)(4) of
the FD&C Act, EES requested review of this denial under section
515(g)(2) (21 U.S.C. 360e(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 the SEDASYS system on October 26,
2010 (Ref. 1). Pursuant to section 515(g)(2) of the FD&C Act, on
November 5, 2010, FDA granted EES's petition for review of the order
denying PMA P080009.
In accordance with section 515(g)(2) of the FD&C Act, the
Commissioner of Food and Drugs (the Commissioner) or her designee is
referring PMA P080009 and the basis for the order denying its approval
to an advisory committee of qualified experts. After independent study
of the data and information furnished by the parties, and other data
and information before it, the advisory committee will submit to the
Commissioner a report and recommendation with respect to the order,
together with the underlying data and information and a statement of
the reasons or basis for the recommendation (section 515(g)(2)(A) of
the FD&C Act). The Commissioner will provide a copy of that report and
recommendation to the petitioner (id.), as well as to CDRH. At this
time, the Commissioner also anticipates offering both the petitioner
and CDRH the opportunity to submit comments on the report and
recommendation before the final order is rendered. In keeping with
section 515(g)(2)(C) of the FD&C Act, the Commissioner will make the
report and recommendation public and issue an order either affirming or
reversing the denial of approval.
In 1999, FDA established a standing advisory committee known as the
Medical Devices Dispute Resolution Panel to provide advice to the
Commissioner on complex or contested scientific issues between FDA and
medical device sponsors, applicants, or manufacturers relating to
specific products, marketing applications, regulatory decisions and
actions by FDA, and Agency guidance and policies (see the charter for
the Medical Devices Advisory Committee (MDAC charter)) (Ref. 2). In a
guidance document entitled ``Resolving Scientific Disputes Concerning
the Regulation of Medical Devices, A Guide to Use of the Medical
Devices Dispute Resolution Panel'' (July 2, 2001) (the Guidance), FDA
clarified that the Medical Devices Dispute Resolution Panel was
established, in part, to receive referrals of petitions for advisory
committee review under section 515(g)(2) of the FD&C Act (Ref. 3).
Accordingly, the Commissioner will refer EES's petition for review
to this advisory committee for a report and recommendation with respect
to the order denying PMA P080009. The Office of the Commissioner will
select the temporary members of, and any consultants to, the advisory
committee, and otherwise ensure that the proceeding is conducted in
accordance with section 515(g)(2) of the FD&C Act, the Federal Advisory
Committee Act, FDA's regulations in 21 CFR part 14 governing its public
advisory committees, the MDAC charter, and any other applicable laws or
regulations. The Office of the Commissioner will also perform the other
duties assigned to FDA under section 515(g)(2) of the FD&C Act. The
Office of the Commissioner will publish a Federal Register notice
concerning the advisory committee meeting at a later date.
Although no statute or regulation requires that separation of
functions be applied to this proceeding, the Agency is observing
separation of functions as a matter of policy in this matter. As the
Center responsible for the action under review, CDRH will be, like EES,
a party to the advisory committee hearing and will be responsible for
presenting its position at that meeting.
In addition, as a corollary to its decision to observe a separation
of functions, until the Commissioner issues an order either affirming
or reversing the order denying approval of PMA P080009, the Office of
the Commissioner will not engage in any ex parte communication (see 21
CFR 10.3(a)) with anyone participating as a party to the hearing or any
person outside the Agency with respect to the matter under
consideration.\1\ Any written ex parte communication will be
immediately served on the two parties and filed in the docket. Any oral
ex parte communication will be immediately memorialized in writing,
served on both parties to the hearing, and filed in the docket.
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\1\ Communications regarding procedural matters between the
Office of the Commissioner and the advisory committee will not be
treated as ex parte communications.
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All documents filed in this matter are filed under Docket No. FDA-
2010-P-0176 and are available for public review in the Division of
Dockets Management (see ADDRESSES) between 9 a.m. and 4 p.m., Monday
through Friday. Persons with access to the Internet may obtain
[[Page 15322]]
documents in the docket at http://www.regulations.gov.
References
The following references are on display in the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20857, under Docket No. FDA-2010-P-0176 and may
be seen by interested persons between 9 a.m. and 4 p.m., Monday through
Friday.
1. Letter from Christy Foreman, FDA, CDRH, to Ken Charak, Ethicon
Endo-Surgery, Inc., containing the order denying approval of the PMA
for the SEDASYS system, October 26, 2010.
2. Charter Medical Devices Advisory Committee; Charter Amendment,
Medical Devices Advisory Committee; FDA; July 15, 2008, http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/ucm124098.htm.
3. ``Resolving Scientific Disputes Concerning the Regulation of
Medical Devices, A Guide To Use of the Medical Devices Dispute
Resolution Panel; Final Guidance for Industry and FDA'' FDA, CDRH; July
2, 2001, http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm.
Dated: March 11, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-6520 Filed 3-18-11; 8:45 am]
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