At the 2019 FDA/Xavier MedCon conference in Cincinnati this week, modernizing the 510(k) program at the US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) was called into question because of limited industry use of the new or expanded 510(k) programs. But CDRH officials remained steadfast in their plans.
Industry struggled to keep pace with the rapidly evolving 510(k) landscape, with 510(k) modernization
initiatives launched in the past few months ranging from new programs such as the least burdensome flag
and Safety and Performance Based Pathway
, as well as the Special 510(k) Pathway’s proposed expansion
The conference sessions on premarket processes were the first time that many industry participants had even heard of the changes. Still, CDRH expressed hope that the changes will garner interest with greater awareness.
“Either we’re doing an excellent job” with 510(k) deficiency letters “or people don’t know this is an option” that has been available since March, said CDRH 510(k) program director Marjorie Shulman in reference to the least burdensome flag. CDRH’s 2018 pilot of the least burdensome flag—an NFL reference—took place internally to evaluate a new approach on resolving issues in 510(k)s. The least burdensome flag is not being used and participants attributed this to the program’s quiet launch.
Questioned on the mechanism used to communicate the availability of the new program, Shulman said CDRH will spread the word on the least burdensome flag. CDRH just began to include an attachment offering the opportunity to use the least burdensome flag, which in turn created some confusion among those that had been unaware of the new program. “I know you all get confused, we're confused,” said Shulman. “There is a lot going on. Reviewers told us that if we start one more pilot, they will walk out.”
Yet another pilot is now taking place at CDRH’s Office of In Vitro Diagnostics and Radiological Health (OIR). OIR is piloting an in vitro
diagnostic-specific smart template. The device version is already in use.
From October 2018, all submitted special 510(k)s began being evaluated using the September 2018 draft guidance’s expansion of eligibility criteria to allow some changes in device use indications. CDRH has yet to receive more special 510(k)s during the pilot phase
versus previous years, according to Shulman. The center intends
to continue running the pilot until it determines it has sufficient data to evaluate success.
Critics of the special 510(k) draft guidance cautioned
against promoting the opposite of a program expansion and potentially restricting changes in certain device types from reviews via special 510(k)s.
Steris senior director of regulatory affairs Bill Brodbeck, however, said the company had used the special 510(k) pilot. “It worked perfectly” and a submitted special 510(k) was cleared in under 30 days.
On the Safety and Performance Based Pathway for 510(k)s of well-known devices, Brodbeck said he is a skeptic mostly because he does not know what the program “really looks like” since work is unfinished.
Joshua Nipper, director of CDRH’s premarket approval application and humanitarian device exemption programs, said draft guidance documents on eligible product codes for use of the new 510(k) pathway will be issued in upcoming weeks to allow for input on the identified objective performance criteria.
“There is an internal list” of product codes “that we’re working off from in trying to get the draft guidances out,” Nipper said.