[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Surgical Devices; Draft Guidance for Industry and Food and Drug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availability of the draft guidance entitled ``Premarket Studies of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draft guidance is not final nor is it in effect at this time.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draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by May 12, 2015.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requests for a single hard copy of the draft guidance document entitled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Submit electronic comments on the draft guidance to http://www.regulations.gov.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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