June 20, 2018
FDA Issues Draft Guidance on Performance Tests and Labeling for Guidewires
June 20, 2018—The US Food and Drug Administration (FDA) has issued a draft guidance document that provides draft recommendations for 510(k) submissions for guidewires intended for use in the coronary, peripheral, and neurovasculature to facilitate the placement of therapeutic devices during percutaneous interventional procedures.
The draft document (available online here) is intended to assist industry in designing and executing appropriate performance testing to support a premarket notification and provides recommendations for content and labeling to include in the submission. When final, this guidance will replace the “Coronary and Cerebrovascular Guidewire Guidance" document dated January 1995.
As stated in the document, the background of the guidance is that there have been many technological advancements since the initial regulation of these devices and since the current final guidance on the topic was published. Therefore, updated information and additional clarity is needed regarding FDA’s recommendations for performance testing and labeling for a 510(k) for new or modified guidewires.
The premarket submission recommendations address the following topics: device description, predicate comparison, biocompatibility, sterility, pyrogenicity, shelf life and packaging, nonclinical bench resting, clinical performance testing, and labeling. Additionally, the document addresses device modifications.
The FDA advised that the draft guidance is issued for comment purposes only. Comments and suggestions regarding the draft document should be submitted within 60 days of publication in the Federal Register of the June 15 notice announcing the availability of the draft guidance. Electronic comments can be submitted to the FDA at: https://www.regulations.gov. Submit written comments to Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Identify all comments with the docket number listed in the notice of availability that publishes in the Federal Register.