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Regulatory News In Brief

New guidance, rules and more from FDA and Congress.

FDA issued its final guidance on humanitarian use designations Jan. 24, following the draft version released last December. (See Also see "FDA Draft Guidance: How To Claim Humanitarian Device Status" - Medtech Insight, 19 December, 2011..) The guidance aims to assist applicants in the preparation and submission of HUD requests. Devices are eligible for HUD designation if they are designed to treat or diagnose a disease or condition that affects or is manifested in fewer than 4,000 individuals in the U.S. per year. Once designated, these devices can be marketed after receiving a humanitarian device exemption, which has a lower approval threshold compared to a PMA. FDA received five comments on the draft guidance, and made minor revisions to improve clarity in the final version.

The agency issued a proposed rule Jan. 25 to classify the scleral plug, a pre-amendment ophthalmic device, into class II with special controls. This device category currently enters...

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