New FDA Guidance on 510(k)s for Guidewires

The FDA offers new advice for devicemakers on 510(k) submissions for guidewires used in coronary, peripheral and neurovasculature in a final guidance released last week.

The FDA notes that guidewires are not required to include directions for lay use, but labeling must include adequate information for the intended user. The information should cover indications, routes, methods, effects, frequency and duration of administration as well as contraindications, side effects, and any relevant hazards.

Submissions for guidewires should include: a device description; a predicate comparison; biocompatibility; sterility; pyrogenicity; shelf life and packaging; non-clinical bench testing; and clinical performance testing, the agency says.

A new 510(k) submission is required for modifications that would affect either the safety and/or efficacy of the device. Examples that would require a new submission include changes to guidewire material, coating, and tip configuration. Changes to device packaging would not likely warrant a new 510(k) submission, the agency says.

The final guidance replaces the agency’s Coronary and Cerebrovascular Guidewire Guidance released in January 1995.

Read the full guidance here: www.fdanews.com/10-10-19-510kguidance.pdf. — Brandon May