2015-02722. Premarket Studies of Implantable Minimally Invasive Glaucoma Surgical Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability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.

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The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled “Premarket Studies of Implantable Minimally Invasive Glaucoma Surgical (MIGS) Devices.”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 This draft guidance is not final nor is it in effect at this time.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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment of this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by May 12, 2015.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 Submit written requests for a single hard copy of the draft guidance document entitled “Premarket Studies of Implantable Minimally Invasive Glaucoma Surgical (MIGS) Devices” to the Office of the Center Director, Guidance and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Submit electronic comments on the draft guidance to http://www.regulations.gov.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When finalized, this draft guidance document will recommend non-clinical and clinical studies to support a PMA for implantable MIGS devices.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 [e-mail] 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 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.