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Medical Devices

Minutes from Stakeholder Meeting on MDUFA III Reauthorization, February 16, 2011

Stakeholder Meeting on MDUFA III Reauthorization
Feb 16, 2011, 1:30 – 4:00 PM
HHS Humphrey Building, Washington, DC
Room 405A

Purpose

To discuss the current performance of the medical device user fee program and key aspects of the total life cycle of a medical device, with a focus on pre-market topics.

Participants

FDA
Bryan Benesch Center for Devices and Radiological Health (CDRH)
Malcolm Bertoni Office of the Commissioner (OC)
Ashley Boam CDRH
Nathan Brown Office of Chief Counsel (OCC)
Helene Clayton-Jeter Office of Special Health Issues (OSHI)
Kate Cook Center for Biologics Evaluation and Research (CBER)
Natalia Comella CDRH
Sharon Davis CDRH
Christy Foreman CDRH
Cindy Garris CDRH
Elizabeth Hillebrenner CDRH
Barbara Myklebust CDRH
Thinh Nguyen OC
Arleen Pinkos CDRH
Synim Rivers OSHI
David Shindell CDRH
Don St. Pierre CDRH
Ruth Watson Office of Legislation (OL)
Barbara Zimmerman CDRH
Stakeholders
Cynthia Bens Alliance for Aging Research
Pamela Bradley American Association for Cancer Research
Paul Brown National Research Center for Women & Families
Susan Campbell WomenHeart
Diane Edquist Dorman National Organization for Rare Disorders
Eric Gascho National Health Council
Donna Goldberg Heart Rhythm Society
Suzanne Henry Consumers Union
Mellanie True Hills StopAfib.org
Darby Hull Consumer Federation of America
Campbell Hutton Juvenile Diabetes Research Foundation
Jennifer Liljeberg American Society of Cataract and Refractive Surgery
Lisa McGiffert Consumer Union's Safe Patient Project
Rebecca McGrath Spina Bifida Association
Andrew Morris United Spinal Association
Kate Ryan National Women’s Health Network
Leslie Stevens Society for Women's Health Research
Cindy Tomlinson American Society for Radiation Oncology
Additional Registered Stakeholders
Jeff Allen Friends of Cancer Research
James Baumberger American Academy of Pediatrics
Hilary Hansen Spina Bifida Association
Lisa Swirsky Consumers Union

Meeting Start Time: 1:40 pm

Performance

FDA provided background on the history of Medical Device User Fee program, the associated performance goals, and described CDRH’s performance to date.

With the authorization of the original medical device user fee program (MDUFMA I, Fiscal Years 2003-2007), FDA received additional funds to support the pre-market review process and committed to performance goals based on review times. Under the program’s reauthorization (MDUFA II, Fiscal Years 2008-2012), both performance goals and user fees were restructured to make funding more stable and predictable and to further improve performance. There was also an overall increase in fees and an expansion of the third party accredited persons inspection program.

The current medical device user fee program has both qualitative and quantitative performance goals. There are quantitative goals for the time FDA takes to review Pre-Market Approval applications (PMAs), Expedited PMAs, PMA modules, 180-day PMA supplements, Real-time PMA supplements, and 510(k)s. Additionally, there are qualitative goals associated with the interactive review process, Investigational Device Exemptions (IDEs), guidances, pre-submissions, and reviewer training through CDRH’s Staff College. The area of in vitro diagnostics (IVDs) has specific qualitative goals for issuing new or revised guidance on a variety of issues, evaluating the potential integration of the 510(k) review process with the CLIA (clinical laboratory improvement amendments) waiver review process, evaluating potential CLIA waiver review performance goals, considering the possible exemption of certain low risk IVDs from pre-market notification, and reviewing the pre-IDE program as it relates to IVDs. Stakeholders asked how risk is defined. FDA evaluates the potential risks of an incorrect result from the IVD.

FDA described CDRH’s current performance relative to MDUFA II quantitative goals. FDA is meeting most PMA Supplement goals and the Original PMA Tier 1 goal; but is not yet meeting the Original PMA Tier 2 goal, although performance is steadily improving. FDA is meeting both performance goals associated with the review of 510(k)s. Prior to MDUFMA I, only 78% percent of 510(k)s were cleared in 90 FDA days. FDA now clears at least 90% of the 510(k) submissions in 90 FDA days and 98% of the submissions in 150 FDA days. FDA acknowledged that total time to market (FDA days + sponsor/manufacturer days) is increasing. When asked by stakeholders why that time might go up, FDA noted that Industry asserts FDA is asking for more information, so it takes longer for the sponsor to respond. FDA believes that both the quality and complexity of the submissions are key factors. While FDA is meeting the majority of the quantitative performance goals, FDA noted that there may be some unintended consequences associated with the goal structure, such as increased time to market for devices reviewed under 510(k).

When asked how the FDA system compared to the EU’s system for reviewing devices, FDA noted the U.S. system differs in many ways from the European model. By statute the FDA must review a device both for its safety and effectiveness; the European system uses Notified Bodies to only look at the safety and performance of the device. Even with this difference data suggests the European systems may not be getting 510(k) devices to market faster. Devices with more stringent clinical data requirements in the U.S., such as PMAs, take more time, but give greater assurance of effectiveness.

The Medical Device Regulatory Process

In order to understand how the performance goals interact with the regulatory process, FDA provided an overview of the regulatory framework. FDA described the three medical device risk-based classes and noted the factors taken into consideration when determining the classification of a device. Class 1 refers to the lowest risk devices. These are subject to general controls such as registration and listing, good manufacturing practices (GMPs), and labeling provisions. Devices in this class are typically exempt from premarket review. Class 2 refers to medium risk devices. These are subject to the general controls outlined above and special controls, which are implemented through guidance documents. Devices in this class typically require clearance of a 510(k) premarket notification submission prior to marketing. Some are exempt from premarket review, but remain subject to design controls (i.e., controls which ensure the design addresses all critical outputs required). Class 3 refers to the highest risk devices. Devices in this class typically represent life supporting/sustaining devices and implants, requiring approval of a PMA submission prior to marketing.

FDA also explained what types of submissions require clinical data. This includes almost all Original PMAs, Panel Track PMA Supplements, and 510(k)s for IVDs; as well as some 180 Day PMA Supplements and approximately 10% of all non-IVDs 510(k)s. FDA further clarified conditions in which the review standards might differ. For devices that qualify for a Humanitarian Device Exemption, the threshold for approval is safety and probable benefit.

510(k)s and Substantial Equivalence

The threshold for clearance of a 510(k) premarket notification submission is substantial equivalence to a predicate device. When new questions of safety and effectiveness arise from changes in technology, the subject device must be reviewed under a PMA. Stakeholders inquired about the use of multiple predicates. FDA noted that only one predicate is required, but sponsors often choose to identify more. All told, the 510(k) workload is the largest premarket program at CDRH, accounting for about 90% of the Center’s total workload.

Premarket application (PMA)

The threshold for approval of a PMA submission is a “reasonable assurance of safety and effectiveness.” This wording differs from the threshold for approval of a New Drug Application (NDA), which is “substantial evidence of safety and effectiveness.” FDA noted several differences between devices and drugs, including the faster rate of technological change of devices, the ease with which in vitro assessments can be performed on devices, the greater impact of physician technique in device use, and the ability to visualize and directly observe performance with a device. Designing device clinical trials poses several challenges that drug trials do not often encounter. For example, when evaluating a device compared to the standard of care, there are often treatment effects which make a cross-over design inappropriate. Device designs change so frequently that iterative changes are common during a clinical study. This results in the need for additional analyses to assess whether the clinical data generated support the design to be marketed. Additionally, blinding of patients and physicians is difficult in device trials. The success of a device can be dependent on the physician’s skill and user interfaces, which are not usually concerns in drug trials.

Post-market Monitoring

FDA emphasized that postmarket monitoring is not a substitute for a premarket review; however it can be an important element of the total product life cycle. FDA discussed the main postmarket oversight tools at its disposal. In some cases, FDA requires an additional clinical study as a condition of approval to assess “real world” device performance or to monitor performance for rare events. If failure of a device is reasonably likely to have adverse health consequences, FDA can issue a 522 Order for a clinical study up to 36 months in duration. FDA noted that it can impose such studies as a condition of clearance on a 510(k) if there is significant use in a pediatric population. In such cases, FDA can require studies in excess of 36 months.

Every year, firms must register and list their devices with FDA. All firms must follow the Quality System Regulation (QSR). This umbrella regulation requires manufacturers to meet established specifications, monitor processes, monitor device performance, and take corrective actions if problems are detected, as well as actions to prevent them from occurring again. FDA attempts to achieve voluntary compliance but FDA can take the following compliance actions: warning letters, seizures, injunctions, civil money penalties, and mandatory recalls. FDA noted that most recalls are voluntary.

Conclusion

FDA believes medical device technology can transform and revolutionize healthcare. The recent 510k report reflects one of FDA’s efforts to adapt to changes in technology. FDA’s goal is for safe and effective devices to reach the market in a timely manner. To do this, FDA requires staff who are up to date on latest technologies, such as nanotechnology and microelectronics. FDA understands science will advance rapidly and that innovation will transform healthcare and improve patient outcomes. FDA needs to be ready to deal with challenges related to innovation so it can continue to protect and promote public health.

Planning Topics for Future Meetings

In light of the topics presented today and the issues raised at the last meeting, FDA asked stakeholders what areas they may wish to discuss at subsequent meetings. Stakeholders offered the following suggestions:

  • Unique device identifiers
  • The President’s budget and finances of the program
  • Increased coordination across Centers on rare diseases
  • How to share information with stakeholders and their constituents
  • Innovation Initiative
  • Interactive review
  • Adverse event reporting

FDA provided some initial responses to the suggestions made. For example, it is difficult to discuss the President’s budget and program finances as these topics are subject to pending appropriations. FDA noted that if the cuts proposed by the House of Representatives is enacted, the impact on FDA would likely slow the review process, as our review standards will not change. With respect to finding and sharing basic information with stakeholders and their constituents, FDA recommended that anyone struggling with how to prepare a regulatory submission contact CDRH’s Division of Small Manufacturers, International and Consumer Assistance (DSMICA). With respect to the Innovation Initiative, FDA invited all to attend the March 15, 2011 public meeting on this topic.

FDA will plan to go into greater detail on some of these topics at future meetings. The next meeting may address adverse event reporting and data analysis.

Schedule of Future Meetings

The next meeting will be held March 22, 2011.

Meeting End Time: 4:15 PM

Page Last Updated: 07/16/2014
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