Document ID: FDA-2010-P-0176-0003
Agency: fda
Document Type: Notice
Title: SEDASYS Computer-Assisted Personalized Sedation System; Ethicon Endo-Surgery, Inc.'s, Petition for Review of FDA's Denial of Premarket Approval
Posted Date: 2011-03-21T04:00Z

[Federal Register Volume 76, Number 54 (Monday, March 21, 2011)]
[Notices]
[Pages 15321-15322]
From the Federal Register Online via the Government Printing 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]
BILLING CODE 4160-01-P