CDRH has reviewed 69 percent of PMA products approved before 2010 — exceeding its 2014 target — as it works to implement a goal of speeding new technologies to patients without compromising safety.
Under its 2014-2015 strategic goal of balancing premarket and postmarket data collection during the premarket application review, CDRH aimed to review half of those product codes by the end of last year. PMA codes created since 2010 weren’t included because the device center needs more information on postmarket performance of these devices before evaluating them for a change in classification or data collection requirements, CDRH says.
In a retrospective review published April 29, CDRH listed 42 product codes identified as candidates for reclassification, three that were reclassified in 2014 and 96 expected to remain unchanged.
The list includes 21 codes for products considered candidates for reclassification into Class II, such as cervical dilators, certain laser and testicular hypothermia devices. Codes were placed in this category if it was determined that special controls would suffice to provide reasonable assurance of safety, CDRH says.
Another 21 codes were determined to be candidates for reduced premarket data and greater reliance on postmarket controls or data collection.
Products under these codes include silicone gel-filled breast prostheses, cervical cytology slide processors and radionuclide microspheres.
Ninety-six codes — including pacemakers and heart valves, intraspinal catheters, cochlear implants, multifocal intraocular lenses, hip prostheses and glucose sensors — should remain in Class III with no changes to data collection, CDRH says.
CDRH is working to have 75 percent of product codes reviewed by June 30 and 100 percent by the end of the year. Once that is done, the FDA will prioritize candidates for reclassification and for change in data collection to determine how to ensure the greatest impact, the review says.
The review follows the release of two guidances by CDRH and the Center for Biologics Evaluation and Research last month on balancing premarket and postmarket data collection for devices and expedited access to devices for patients with life-threatening or irreversibly debilitating conditions.
CDRH seeks public comment until June 29 on the product codes it has reviewed. Read the guidance at www.fdanews.com/04-28-15-Pre
market.pdf. — Charlotte Astor