A Medical Device Daily
User fees for medical device makers have generated some expectations of FDA's review times for various applications, and those expectations have not always been met. Hence, the announcement last week that FDA's review cycle goals for the next five years will tighten timelines for many types of applications might understandably be met with some skepticism by industry.
On the other hand, the agency has set a target number of review days for the entire five years, whereas the objectives in the previous five-year agreement grew more demanding. Whether this fact will mollify industry remains to be seen.
In 2006, officials at the Centers for Devices and Radiological Health acknowledged that while 510(k) applications were more or less on schedule (75% turned around within 90 days), the timelines for PMAs had ballooned (Medical Device Daily, May 24, 2006). Deputy director of CDRH Linda Kahan said at a May 22, 2006, meeting that the issuance of a major deficiency letter at 150 days often left sponsor and agency with more work than they could both complete in the 30 days remaining to bring in the application under the "stretch" goal, which was completing half of all PMAs within the 180-day window.
Kahan also said at the time that FDA took in fewer, not more, dollars as a result of the Medical Device User Fee Stabilization Act, passed in 2005, further complicating the picture for FDA's device review capacity.
All the same, expectations may be ramped up again with the publication of FDA's latest guidance document on the performance goals for turn-around of PMAs and other applications, which were reset as part of the FDA Amendments Act of 2007.
The document, which is dated June 30 but was not released until July 3, notes that the objective for traditional PMAs and panel-track supplements for the years 2008-2012 will be to complete the review within 180 days for 60% of all applications. Under the previous schedule, put in place by the second iteration of the Medical Device User Fee Modernization Act (MDUFMA), the objective was to complete only 50% within 180 days.
The secondary goal for PMAs and panel track supplements for the next five years is to wrap up 90% of all applications within 295 days, whereas the previous goal was to finish the same percentage in 320 days.
FDA may be shooting for faster turn-around of some of the interim steps in the process for traditional PMAs and panel-track supplements, but the document states that "there are no cycle goals" for the next five years. For the previous half decade, the target number of elapsed days for the issuance of a major deficiency letter was 150 days, which as was noted earlier, often put the sponsor and the agency in a crunch to hit the 180 day mark for completion of the agency's review of the application. The guidance says only that "if we issue a major deficiency letter as a first action, then we have the remaining number of days allotted ... to complete our review."
Another area of change is how the agency will handle PMA modules. According to the guidance, the cycle goal for modules is to get 75% of them out the door within 90 days and 90% by 120 days. However, the agency also notes "the cycle goals for individual PMA modules do not apply once the final module is submitted." At that point, "all open modules are considered closed," and the agency assumes that any issues remaining from all but the last module are addressed in the final module. "Then the modular PMA is assigned a PMA number ... and we apply the performance goals for a traditional PMA."
RHCs to file quality reports
CMS has published a rule that will allow Medicare beneficiaries living in rural areas to continue to receive healthcare services from rural health clinics (RHCs) so long as those clinics establish quality assessment and performance improvement (QAPI) programs.
RHCs have traditionally enjoyed higher reimbursement rates than their suburban and urban counterparts in an effort by CMS to boost the availability of primary care doctors and other personnel, such as nurse practitioners, in rural areas.
According to the June 26 announcement, RHCs would also have to establish location requirements, presumably a reference to population density in the area served. Existing RHCs can obtain an exemption from this location requirement, but the statement offered no details.
Acting CMS administrator Kerry Weems said that the proposed changes "to the rural health clinic program would ensure that Medicare beneficiaries in rural underserved areas have ready access to high quality primary healthcare from physicians and certain non-physician providers" with the intent of ensuring that "beneficiaries and Medicare get the best value from RHC providers."
The rule is also said to clarify when an RHC "could share resources with an on-site Medicare or Medicaid fee-for-service provider to allow greater flexibility in providing needed services for beneficiaries."