MDUFA Comments Call for Improved Review Times, Better Staff Training

As the FDA continues negotiations with industry on reauthorization of the Medical Device User Fee Amendments for 2018 to 2022, stakeholders have offered recommendations for improving the program.

Returning review times to pre-user fee program levels and ensuring predictable application evaluations are two themes that appear in comments to a docket posted ahead of a July 13 public meeting that started the clock on the MDUFA reauthorization. Comments were due Aug. 12.

LifeScience Alley, which represents life sciences businesses in Minnesota, says improving review timetables is crucial to encouraging innovation.

“We urge the FDA to make review timetables, consistency and predictability a highest priority and to implement the changes necessary for rapid improvement,” according to the group’s comments.

The Medical Imaging & Technology Alliance voices similar concerns, noting that “increased and unpredictable data requests” have led to inconsistent use of the interactive review process. Decisions on 510(k)s are taking longer than the historical average, with reviewers increasingly asking applicants to submit additional data.

Training Concerns

Comments also urge the agency to hire and train staff to ensure consistency in application reviews.

As the American College of Cardiology notes, understanding the complexity of medical devices requires training and a scientific background. However, those with the knowledge and skillsets to fulfill these duties often are wooed to the private sector with the promise of higher salaries.

While that may continue to remain a problem, the ACC encourages the FDA to engage with national medical specialty societies to develop programs to enhance the educational development of staff. It also reminds the agency of its Network of Experts, which is designed to identify clinical experts to help CDRH employees. This program, according to the ACC, has not been utilized adequately.

“The college encourages the agency to better promote this program to its staff and to provide it the necessary resources,” the comments note. Beyond that network, the agency should allocate funds to support infrastructure to provide the agency with access to experts in the appropriate fields.

The American Association of Orthopaedic Surgeons recommends that FDA personnel participate in research and scientific meetings to gain knowledge and develop solid working relationships with industry. MITA agrees, adding that there should be qualitative goals for training, industry-FDA meetings, regulatory science and guidance development.

Postmarket Surveillance

Comments also praise the agency for enhancing postmarket surveillance and adopting a total product lifecycle approach to ensure the safety of devices.

“It is impossible to know everything about a medical device from a randomized clinical trial; a device’s full capabilities and problems will not be identified until it is used and observed in the real world,” the ACC says.

To further improve postmarket surveillance, the group recommends that MDUFA IV include funding for the following activities:

• The implementation of a National Medical Device Postmarket Surveillance System Planning Board, as issued by the Brookings Institution earlier this year (IDDM, Feb. 27);
• The development and ongoing maintenance of medical device registries to collect real-world data;
• The identification of novel techniques for postmarket surveillance, such as the DELTA pilot studies in the National Cardiovascular Data Registry; and
• The drafting and implementation of regulations and guidance to address issues related to the use of existing data sets for FDA-regulated activities.

Meanwhile, the Pew Charitable Trusts says postmarket surveillance could be enhanced through the creation of a body dedicated to device data collection. That entity would encourage the adoption of common data standards; ease the sharing of data on medical devices from electronic health records, claims and registries across the healthcare system; and support standards for the capture and exchange of unique device identifiers.

The organization also promotes utilizing user fees to include UDI in the postmarket surveillance Sentinel program, which currently uses claims data to examine the safety of drugs. Congress required the FDA to expand the program to devices in 2012, and Pew says the agency worked on ways to expand Sentinel to evaluate to healthcare technology.

The comments are available at: AAOS: www.fdanews.com/083115-AAOS-comments.pdf;
ACC: www.fdanews.com/083115-ACC-comments.pdf; LifeScience Alley: www.fdanews.com/083115-lifescience-alley-comments.pdf; MITA: www.fdanews.com/083115-MITA-comments.pdf; and Pew: www.fdanews.com/083115-Pew-comments.pdf. — Elizabeth Hollis