[Federal Register Volume 80, Number 28 (Wednesday, February 11, 2015)]
[Notices]
[Pages 7614-7615]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-02722]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-0288]


Premarket Studies of Implantable Minimally Invasive Glaucoma 
Surgical Devices; Draft Guidance for Industry and Food and Drug 
Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the draft guidance entitled ``Premarket Studies of 
Implantable Minimally Invasive Glaucoma Surgical (MIGS) Devices.'' This 
leap frog guidance document was developed to notify manufacturers of 
the recommended non-clinical and clinical studies to support a 
premarket approval application (PMA) for implantable MIGS devices. This 
draft guidance is not final nor is it in effect at this time.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment of this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by May 12, 2015.

ADDRESSES: An electronic copy of the guidance document is available for 
download from the Internet. See the SUPPLEMENTARY INFORMATION section 
for information on electronic access to the guidance. Submit written 
requests for a single hard copy of the draft guidance document entitled 
``Premarket Studies of Implantable Minimally Invasive Glaucoma Surgical 
(MIGS) Devices'' to the Office of the Center Director, Guidance and 
Policy Development, Center for Devices and Radiological Health, Food 
and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, 
Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to 
assist that office in processing your request.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852. Identify comments with the docket number 
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Michelle Tarver, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave. Bldg. 66, Rm. 2504, Silver Spring, MD 20993-0002, 301-
796-5620.

SUPPLEMENTARY INFORMATION:

I. Background

    When finalized, this draft guidance document will recommend non-
clinical and clinical studies to support a PMA for implantable MIGS 
devices. Glaucoma is a progressive condition that damages the optic 
nerve of the eye, is associated with elevated intraocular pressure, and 
leads to irreversible vision loss. It is the second leading cause of 
visual disability and blindness in the world, with 1 in 40 adults over 
40 years of age suffering from glaucoma having some visual loss. 
Current surgical treatments are aimed at reducing intraocular pressure 
(IOP) and often reserved for moderate to severe disease. During the 
past decade, novel medical devices, called MIGS devices, have emerged. 
These devices are designed to treat less severe glaucoma by enhancing 
physiological aqueous outflow with an approach that causes minimal 
ocular trauma.
    This draft guidance is a leap-frog guidance; leap frog guidances 
are intended to serve as a mechanism by which the Agency can share 
initial thoughts regarding the content of premarket submissions for 
emerging technologies and new clinical applications that are likely to 
be of public health importance very early in product development, 
generally before FDA has even received any such submissions. This leap-
frog guidance represents the Agency's initial thinking and our 
recommendations may change as more information becomes available. The 
Agency strongly encourages manufacturers to engage with the Center for 
Devices and Radiological Health (CDRH) through the Pre-Submission 
process to obtain more detailed feedback for implantable MIGS devices. 
For more information on Pre-Submissions, please see ``Requests for 
Feedback on Medical Device Submissions: The Pre-Submission Program and 
Meetings with Food and Drug Administration Staff'' (http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM311176.pdf).

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the Agency's current thinking on implantable 
MIGS devices. It does not create or confer any rights for or on any 
person and does not operate to bind FDA or the public. An alternative 
approach may be used if such approach satisfies the requirements of the 
applicable statute and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do 
so by downloading an electronic copy from the Internet. A search 
capability for all CDRH guidance documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance documents are also available at 
http://www.regulations.gov. Persons unable to download an electronic 
copy of ``Premarket Studies of Implantable Minimally Invasive Glaucoma 
Surgical (MIGS) Devices'' may send an email request to [email protected] to receive an electronic copy of the document. 
Please use the document number 1400049 to identify the guidance you are 
requesting.

IV. Paperwork Reduction Act of 1995

    The guidance document ``Premarket Studies of Implantable Minimally 
Invasive Glaucoma Surgical (MIGS) Devices'' refers to previously 
approved information collections found in FDA regulations and guidance. 
These collections of information are subject to review by the Office of 
Management and Budget (OMB) under the Paperwork Reduction Act of 1995 
(44 U.S.C. 3501-3520). The collections of information in 21 CFR part 
814, subparts B and E are approved under OMB control number 0910-0231 
and the collections of information in the guidance document entitled 
``Requests for Feedback on Medical Device Submissions: The Pre-
Submission Program and Meetings with

[[Page 7615]]

Food and Drug Administration Staff'' are approved under OMB control 
number 0910-0756.

V. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

    Dated: February 5, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-02722 Filed 2-10-15; 8:45 am]
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