[Federal Register Volume 80, Number 240 (Tuesday, December 15, 2015)]
[Notices]
[Pages 77634-77636]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-31407]


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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; Guidance for Industry and Food and Drug 
Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of the guidance entitled ``Premarket Studies of 
Implantable Minimally Invasive Glaucoma Surgical (MIGS) Devices.'' This 
leapfrog 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.

DATES: Submit either electronic or written comments on this guidance at 
any time. General comments on Agency guidance documents are welcome at 
any time.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

[[Page 77635]]

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2015-D-0288 for ``Premarket Studies of Implantable Minimally 
Invasive Glaucoma Surgical (MIGS) Devices.'' Received comments will be 
placed in the docket and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at http://www.regulations.gov or at 
the Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.
     Confidential Submissions: To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    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 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.

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

    This guidance document recommends 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 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.
    In the Federal Register of February 11, 2015 (80 FR 7614), FDA 
announced the availability of the draft of this guidance. Interested 
persons were invited to comment by May 12, 2015. FDA received and 
considered 12 sets of public comments and revised the guidance, where 
applicable. Multiple comments were received regarding the definition of 
glaucoma and the inclusion of pre-perimetric glaucoma. Based on 
discussion at the ``FDA/American Glaucoma Society Workshop on 
Supporting Innovation for Safe and Effective Minimally Invasive 
Glaucoma Surgery,'' February 26, 2014, we do not believe that pre-
perimetric glaucoma (i.e., optical coherence tomography changes and 
optic nerve changes without any field abnormalities) should be included 
in these interventional studies because there are differing opinions 
amongst experts about whether this condition warrants surgical 
treatment. This guidance is a leapfrog guidance; leapfrog 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 leapfrog 
guidance represents the Agency's initial thinking and our 
recommendations may change as more information becomes available. The 
current recommendations are designed to provide a conservative approach 
to protection of human subjects.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on ``Premarket Studies of Implantable Minimally 
Invasive Glaucoma Surgical (MIGS) Devices.'' It does not establish any 
rights for any person and is not binding on FDA or the public. You can 
use an alternative approach if it satisfies the requirements of the 
applicable statutes and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by 
downloading an electronic copy from the Internet. A search capability 
for all Center for Devices and Radiological Health 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

[[Page 77636]]

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

    Dated: December 8, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-31407 Filed 12-14-15; 8:45 am]
 BILLING CODE 4164-01-P