MedCon: CDRH plans return to normal pre-submission timelines

The head of the US Food and Drug Administration’s (FDA) device center says the agency is planning to get back to normal pre-submission timelines soon. His office hit the pause button for certain pre-submission meetings and delayed others to conserve its resources during the COVID-19 pandemic.
 
Jeff Shuren, director of the Center for Devices and Radiological Health (CDRH), said, “Staring fairly soon,” FDA will reopen its pre-submission doors after the agency had to make some tough choices about the program last year.
 
In April 2021, FDA announced it would only accept pre-submission meetings for in vitro diagnostics (IVDs) if they were related to the COVID-19 pandemic, companion diagnostics, breakthrough designation requests, or those with a significant public health impact. All other IVD pre-submission meetings were put on hold because the agency did not have enough staff to allocate to those meetings. For other medical devices, the agency offered an extended timeline; 120 days instead of the normal 70 days.
 
“We had put on hold pre-submissions for many circumstances for IVDs because that was part of the center hardest hit but we are going to open that back up in the very near future as we start to return to normal,” Shuren said during the virtual annual MedCon Conference on 4 May, which was hosted by the Association of Food and Drug Officials (AFDO) and the Regulatory Affairs Professionals Society (RAPS).
 
“We had limited pre-submissions in some of the product areas over a year ago, particularly for IVDs,” he added. “We had that in our Office of Health Technology 4, for example, with personal protective equipment, and in our Office of Health Technology 1 with a number of ventilators and other respiratory technologies because they were hammered by COVID.”
 
For the delayed pre-submission meetings, Shuren said that FDA has sped up its timelines and for the most part is caught back up.
 
On IVDs, however, he noted that FDA will still have longer timelines as it goes through a backlog of pre-submission requests.
 
“We think we're at the point where we can take on more,” said Shuren. “It will be slower for IVDs but better that we do it slower than we don't do it all for folks because we know how important it is for developers to get that feedback.”
 
“It's just one more sign of our attempts to … return to normal,” he added.
 
FDA has touted the pre-submission process over the years as means of giving sponsors more opportunities to address questions and to ascertain what FDA wants to see in premarket applications, before submitting products for review. These early conversations can provide sponsors more certainty about what FDA needs to get products on the market.
 
During his talk, Shuren also discussed FDA’s proposed total product lifecycle advisory program (TAP), which was a major sticking point with industry during the Medical Device User Fee Amendments (MDUFA V) negotiations. Both sides eventually agreed to fund a pilot program to assess the viability of the program before funding a fully-fledged TAP program.
 
Shuren noted that the objective of the TAP program is to go beyond the capabilities of the pre-submission program. It is designed to include discussions with other stakeholders such as physician and patient advocates, as well as health insurance providers, during the product development phase. A major objective is of the program is to have a product ready for reimbursement once it’s been given the green light by FDA to avoid what industry calls, “the valley of death.” (RELATED: MDUFA V: Commitment letter includes TPLC pilot, claw back provisions and more, Regulatory Focus 23 March 2022)
 
“TAP really comes out of our COVID experience with [pre-emergency use authorization meetings] where we knew if we can engage with developers in more near real-time, have a fluid dynamic and be able to proactively problem solve, we can rapidly expedite development on technologies,” said Shuren.
 
He noted that if Congress approves the negotiated MDUFA V deal to include the TAP pilot, it will fund a small cadre of TAP advisors who can think strategically and quickly address issues. They would even go so far as to reach out to the sponsors to check on them if they haven’t heard from them in a while. (RELATED: Burr chastises FDA at second Senate user fee hearing, Regulatory Focus 26 April 2022)
 
“That's the goal, move away from your traditional pre-submission meeting and move to faster, more fluid engagement,” said Shuren. “But it is a pilot and we will learn from it, and we'll see if this is something that ultimately would continue moving into MDUFA VI.”