Expediting approval procedures for devices at blood centers
This Act directs the FDA to establish an expedited process for approving supplemental applications from blood centers seeking to add apheresis collection devices to locations not previously licensed for such devices. The FDA must approve these applications within 30 days unless specific concerns regarding product safety or systemic operator failures exist. The procedure applies to entities that already hold a biologics license and meet specific criteria.
Key points
The FDA has 180 days from enactment to establish an expedited procedure for applications to add apheresis devices at new locations.
Expedited applications must be approved within 30 days of submission unless concerns regarding safety, purity, or potency of products are shown.
The procedure applies to operators holding a biologics license (BLA) who are accredited or hold licenses for at least 3 registered locations.
Introduced
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