Last month, FDA announced that it plans to complete classification actions for remaining preamendments devices by the end of 2014. These actions could take the form of orders requiring the filing of premarket approval applications (PMAs) or notices of completion of a product development protocol (PDPs) for various devices (referred to as “calls for PMAs”) or reclassification orders. With the most recent round of proposed orders calling for PMAs, it appears that the agency is making significant progress towards meeting this goal.
As we previously reported, in January, FDA issued a proposed order that would require the filing of PMAs or PDPs for metal-on-metal hip joint implants. In March, FDA issued a proposed order requiring PMAs or PDPs for automated external defibrillators and their accessories (i.e., pad electrodes, batteries, and adapters). And last week, on April 4, FDA issued a proposed order requiring PMAs or PDPs for three Class III preamendment devices:
- sorbent hemoperfusion devices for the treatment of hepatic coma and metabolic disturbances;
- cranial electrotherapy stimulator for the treatment of depression; and
- transilluminator for breast evaluation.
According to the proposed order, FDA intends that any manufacturer that wishes to continue marketing one of these devices will need to file a PMA or PDP within 90 days of the effective date of the final order, should such order be issued. FDA also proposed that sorbent hemoperfusion devices for the treatment of poisoning and drug overdose be reclassified from a Class III (premarket approval) to a Class II (special controls) device. Comments are due by May 6, 2013.
This latest round of FDA “calls for PMAs” follows the creation of more streamlined procedures for these actions in the Food and Drug Administration Safety and Innovation Act (FDASIA), enacted in July 2012. Before FDASIA, the process for requiring PMAs had to proceed by notice-and-comment (i.e., informal) rulemaking. FDASIA § 608 modified this requirement, permitting FDA to require PMAs and reclassify devices via administrative order rather than informal rulemaking. FDASIA also directed FDA to either issue administrative orders requiring PMA approval for the preamendment devices or reclassify them into Class I or Class II within 2 years of enactment. As of April 8, 2013, FDA has issued proposed administrative orders for ten preamendment devices.