FDA set SUDs (single-use devices) enforcement date:
This article was originally published in Clinica
The US FDA has warned that it intends to begin enforcing its premarket requirements for reprocessed single-use devices (SUDs) starting on February 14. The agency posted its "reminder to all concerned parties" on its special reuse website. Reprocessors must have approved PMAs or cleared 510(k)s for high-risk (class III) and medium-risk (class II) reprocessed devices by February 14 or risk facing an FDA enforcement action, the agency said. February 14 is also the deadline for submission of a 510(k) for class I, non-exempt, single-use devices, it noted. The FDA intends to process these latter submissions by August 14.