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Select Updates for Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

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AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled “Select Updates for Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems.” FDA has developed this guidance to inform the coronary and peripheral stent industry about selected updates to FDA's thinking regarding certain non-clinical testing for these devices. While FDA is considering more substantial updates to the “Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems” guidance (http://www.fda.gov/​medicaldevices/​deviceregulationandguidance/​guidancedocuments/​ucm071863.htm), we are issuing this update on select sections in order to notify the industry in a timely manner of our revised recommendations. This draft guidance is not final nor is it in effect at this time.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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by September 30, 2013.

ADDRESSES:

Submit written requests for single copies of the draft guidance document entitled “Select Updates for Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems” to the Division of Small Manufacturers, International, and Consumer Assistance, Center for Devices and Radiological Health (CDRH), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4613, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your request, or fax your request to 301-847-8149. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance.

Submit electronic comments on the draft guidance to http://www.regulations.gov.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.

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FOR FURTHER INFORMATION CONTACT:

Lindsay Pack, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.66, Rm. 1270, Silver Spring, MD 20993-0002, 301-796-5214; or Erica Takai, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.62, Rm. 3226, Silver Spring, MD 20993-0002, 301-796-6353.

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SUPPLEMENTARY INFORMATION:

I. Background

FDA held a public workshop entitled “Cardiovascular Metallic Implants: Corrosion, Surface Characterization, and Nickel Leaching” on March 8 and 9, 2012, that provided information on current practices for performing these tests (see http://www.fda.gov/​MedicalDevices/​NewsEvents/​WorkshopsConferences/​ucm287535.htm). A group of participants from industry, test facilities, and academia provided comments on practices for corrosion testing and nickel ion release testing. Based on the discussion at the workshop, this draft guidance updates a key aspect of sample conditioning for pitting corrosion testing that is less burdensome, and includes additional information on when galvanic corrosion testing may be omitted with justification, based on information gained from the workshop. This guidance provides updates only for the following topics:

  • Pitting corrosion potential;
  • Galvanic corrosion;
  • Surface characterization; and
  • Nickel ion release.

This draft guidance provides cross-references and updates to the related sections of the existing “Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems” guidance. Following the close of the comment period on this guidance, FDA intends to consider the comments received, revise this draft guidance as appropriate, and publish it in final. Simultaneously, FDA will issue an update to the existing guidance to add cross-references where this selected updates guidance supersedes the existing recommendations. Subsequently, FDA will incorporate the elements of the final select updates guidance into an anticipated revision of the entire “Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems” guidance.

This draft guidance also lists the relevant product codes for stents addressed in the guidance. Of note is that the product code NXP (Stent, Tibial), which is not currently listed in the existing “Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems” guidance, has been added. This product code was not created until after the current guidance was published, however, the recommendations in this draft guidance are applicable to tibial stents. Further, FDA will include this product code in the anticipated revision of the entire “Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems” guidance.

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 certain non-clinical testing for coronary and peripheral stents. 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 using 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.

To receive “Select Updates for Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems,” you may either send Start Printed Page 53774an email request to dsmica@fda.hhs.gov to receive an electronic copy of the document or send a fax request to 301-847-8149 to receive a hard copy. Please use the document number 1826 to identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

This draft guidance refers to previously approved collections of information found in FDA regulations. 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 have been approved under OMB control number 0910-0231.

V. Comments

Interested persons may submit either electronic comments regarding this document to http://www.regulations.go v 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.

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Dated: August 23, 2013.

Leslie Kux,

Assistant Commissioner for Policy.

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[FR Doc. 2013-21191 Filed 8-29-13; 8:45 am]

BILLING CODE 4160-01-P