AdvaMed Lauds Process Improvements in New User Fee Agreement

The Advanced Medical Technology Association (AdvaMed) praised several process improvements included in the recently announced medical device user fee agreement with FDA, stressing they would lead to greater efficiency, consistency and accountability in the agency’s device review process.
 
Key among the process improvements in the agreement is a new goal under which FDA commits to providing meaningful written feedback to companies at least five days prior to a scheduled pre-submission meeting. The agency also will update its guidance on the pre-submission process. In addition, for the first time, FDA will be required to document the scientific rationale for issuing a deficiency letter to a sponsor.
 
The agreement will increase patient input into the regulatory process by leveraging public-private partnerships and allowing for the voluntary use of publicly available and validated Patient Preference Information (PPI) or Patient Reported Outcomes (PRO) in device regulatory submissions. In addition, user fee funds will be dedicated to developing expertise within FDA’s device center to respond to submissions with PPI and PRO information.
 
MDUFA funding also will be devoted to a pilot project to assess whether real-world evidence (RWE) can be used to support premarket activities. This three-year pilot will look at the use of RWE for expanded indications for use, new clearances and approvals, and improved malfunction reporting. Stakeholders including industry will participate in overseeing the coordinating center that will establish the pilot.
 
“Industry strongly supports the expanded input and involvement the patient community will have in the device regulatory process under this agreement,” said Scott Whitaker, AdvaMed president and CEO. “Properly validated PPI and PRO information can play an enormous role in fostering medical technology innovation and improving patient care.”
 
“Likewise, we believe there is great potential in the use of real-world evidence to improve patient care, but it is important to ensure that any such data is valid and accurate. We look forward to the results of the pilot program to assess the potential of these additional data sources.”
 
Under the new user fee agreement, FDA has committed to significant improvements for total review time goals. For 510(k)s, the average total time goal will drop to 108 days by FY 2022, which is near to the historical norms for 510(k) reviews a decade ago; for PMAs, at the end of the new user fee agreements, the average total time goal is 290 days, a 25 percent decrease from the current benchmark. In addition, first-time goals for de novo products call for FDA to make a decision within 150 days for 70 percent of submissions by FY 2022.
 
The agreement provides FDA $999.5 million in funds over five years, building off the previous user fee agreement of approximately $679 million, plus $228 million in new resources to improve the device review process. In addition, the total funding includes $92.5 million in one-time operational costs to support other aspects of the agreement.
 
“All together, these additional resources represent a reasonable contribution from industry in support of activities that will allow FDA to continue to improve its performance and fulfill its mission of protecting the public health and promoting innovation,” said Whitaker. “This is a good deal for FDA, for industry and most importantly for patients, and we look forward to working with all to ensure its successful implementation.”