- A new Booz Allen Hamilton report evaluating FDA’s medical device review process under the Medical Device User Fee Amendments IV found the agency’s device center has successfully implemented the consultancy’s 11 recommendations to improve the review program made in June 2014.
- The 11 recommendations fall under four categories: standardizing Center for Devices and Radiological Health operations, increasing staff knowledge to perform submission reviews, increasing clarity of the regulatory process and improving consistency of decision-making consistency.
- Next steps for FDA to continue improvement, according to Booz Allen, include: further consolidation of IT systems; building more accurate workload tools; providing more online, on-demand or more frequent in-person training sessions for staff; examine the steady withdrawal rate of accepted submissions; and continue to promote earlier interactions with sponsors to resolve submission issues.
Booz Allen noted FDA has undertaken a number of efforts to keep up with a rapidly evolving industry such as its digital technology efforts and its Office of Product Evaluation and Quality pilot aimed at creating a super office dealing with high level regulatory and policy issues.
“The Center should carefully manage the impact that these and any additional changes may have on staff to ensure smooth implementation and adoption,” the report said.
Of 136 CDRH staff surveyed, 102 said improved access to information about previous regulatory decisions of similar devices would improve decision-making consistency and increase review efficiency. Eighty-nine said more structured electronic submissions from sponsors would also be an impactful change.
In September, FDA launched a pilot program aimed at cutting 510(k) review times to as little as 60 days by utilizing eSubmitter software to generate better-organized submissions.
“This new approach is like a Turbo Tax for information submitted in 510(k)s,” FDA Commissioner Scott Gottlieb said at the time.
Booz Allen encouraged FDA to continue to develop resources that result in structured electronic submissions to help staff.