* 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This draft guidance provides cross-references and updates to the related sections of the existing "Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents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,
This draft guidance also lists the relevant product codes for stents addressed in the guidance.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This product code was not created until after the current guidance was published, however, the recommendations in this draft guidance are applicable to tibial stents.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,
II. Significance of Guidance
This draft guidance is being issued consistent with
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Persons interested in obtaining a copy of the draft guidance may do so by using the Internet.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 an email request to firstname.lastname@example.org 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This draft guidance refers to previously approved collections of information found in
Interested persons may submit either electronic comments regarding this document to http://www.regulations.go v or written comments to the
Assistant Commissioner for Policy.
[FR Doc. 2013-21191 Filed 8-29-13;
BILLING CODE 4160-01-P
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