510(k) Retooling-Part 2: Increased Industry Burden | Orthopedics This Week
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510(k) Retooling-Part 2: Increased Industry Burden

Image created by RRY Publications/Source: Wikimedia, FDA

In Part One of our review of FDA recommendations to fix the 510(k) program we asked if these suggestions were a solution in search of a problem. In Part Two, our legal and medical experts offer up their views on the burdens these recommendations will add to industry and physicians.

Here’s a preview: The recommendations will likely cause more industry headaches in the development of innovative device technologies.

Something’s Gotta Be Done

After the ReGen Biologics fiasco, internal scientist whistleblowers and industry criticism that the 510(k) program had become unpredictable, the agency, under new leadership, decided that changes were needed.

The new Director of the Center for Device and Radiological Health (CDRH), Jeff Shuren, M.D., convened 10 internal workgroups and asked the Institute of Medicine (IOM) to conduct an external review of the program.

The internal review was completed last month and on August 3, the agency released 70 recommendations to retool the clearance program. The IOM’s recommendations are expected next summer.

Shuren said the recommendations were designed to help the agency achieve three main objectives: foster innovation, increase predictability and enhance safety.

In Part One of our series, we highlighted the evidence University of Minnesota Law Professor Ralph Hall and his research team presented to the IOM earlier this year regarding the safety record of the program. Hall's research showed that during a five-year period, 99.78% of all 510(k) applications did not result in a product recall.

Viewpoints From the Lawyer and the Physician

William Mihalko, M.D.
Here in Part Two, we ask Professor Hall and AAOS (American Academy of Orthopaedic Surgeons) member William Mihalko, M.D., to give their opinions on whether or not the recommendations hit the mark of fostering innovation and making the clearance process more predictable for industry and physicians. Mihalko is one of the Academy leaders monitoring the IOM proceedings. He will have a significant voice in how the Academy responds to the agency's recommendations.

Below are CDRH Director Shuren’s highlighted recommendations. After each recommendation, Dr. Mihalko offers his opinion on whether the recommendation will enhance or impede a physician’s ability to provide patients with new and better medical procedures.

I. Fostering Medical Device Innovation
  1. Streamline the premarket pathway for lower-risk novel devices (de novo pathway).

    The de novo classification process is a regulatory pathway for novel devices that cannot be cleared through the 510(k) process because they lack a clear predicate, but do not warrant a premarket approval (PMA) level of review. This process is associated with lengthy review timeframes and nontransparent data requirements.

    The FDA recommends major reforms in the implementation of the de novo process, including steps to streamline the process and clarify the Center’s evidentiary expectations for de novo requests.


  2. Enhance science-based professional development for CDRH staff.

    The FDA recommends enhanced training and professional development for agency staff. The agency recommends these efforts include providing greater opportunities for staff to stay abreast of recent scientific developments and current clinical practice.


  3. Establish a network of external experts.

    The FDA recommends continued efforts to develop a network of external experts using web-based social media technology. Such a network would allow staff to leverage outside knowledge in order to answer scientific questions without requiring experts to serve in an advisory capacity.

    Mihalko: "This would be difficult to predict due to the issues impeding external reviewers from accessing previous data and reports which would aid in the external review process."

II. Enhancing Predictability
  1. Establishing “Class IIb.”

    Most concerns raised have involved the small subset of devices for which staff requested clinical information midway through a review. The submitter thus had no advance notice that such information would be needed and this has lead to avoidable delays.

    The FDA recommends the development of guidance to define a subset of Class II devices called “Class IIb”, for which clinical or manufacturing information would typically be necessary to support a substantial equivalence determination.

    Mihalko: He says that in orthopedics, "multiple devices need to be reclassified and this may give an avenue for a quicker reclassification of devices from Class III." As an example he cites mobile bearing knees.

  2. Create a new “Notice to Industry” tool to communicate changes in premarket expectations.

    The FDA may need to modify premarket evidentiary expectations for certain types of devices as science evolves and new information emerges about the risks and benefits of a device type. Current law has not allowed the agency to communicate such changes in a rapid manner. Instead, manufacturers typically learn of these changes through individual engagement with the Center, often not until after they have prepared their premarket submissions.

    The FDA recommends that CDRH begin to use standardized “Notice to Industry” letters to quickly communicate when the agency has changed regulatory expectations. This would apply to a particular group of devices, the general nature of the change, and the rationale for the change.

    Mihalko: No impact on physicians.

  3. Clarify “substantial equivalence” review standards.

    Insufficient clarity in the definition of “substantial equivalence” has contributed to inconsistency in the agency's decision making, internal and external debates, and delays in review.

    The FDA recommends that CDRH more clearly define these terms in guidance and training for review staff and industry.

    Mihalko: He believes this will allow applicants to provide the necessary information upfront to reviewers and minimize the need for the FDA to ask further questions after the initial application process.

  4. Establish a Center Science Council.

    The FDA recommends the establishment of a Center Science Council, under the direction of the Deputy Center Director for Science. This body would be responsible for overseeing science-based decision making, including: premarket reviews, periodical auditing decisions and assessing program performance. It would also be in charge of and acting as a resource for staff on scientific questions, supporting greater consistency in decision making and the treatment of cross-cutting issues.

    (Note: The agency has already established this Council. It is headed by Bill Maisel, M.D. Part Three of our series on the clearance program overhaul will focus on this Council and the potential impact on industry and physicians.)

    Mihalko: "More levels of review are not necessary, " says Mihalko. He supports better training and retention of reviewers.

III. Improving Patient Safety
  1. Require more upfront submission of safety and effectiveness data.

    The FDA recommends requiring submitters to provide a summary of all scientific information known, or that should be reasonably known, regarding the safety and/or effectiveness of the device.

    Under current regulations relevant information may not be included upon initial submission, even when that information is readily available to the submitter. This would allow review staff to make decisions that consider all relevant safety and effectiveness information. Shuren says this should not present a significant additional burden for submitters.

    Mihalko: He says there is no evidence, especially in orthopedic devices, that a current safety issue exists. He says that through guidance and document development, the safety issues will become even more negligible.

  2. Create a searchable online public database.

    The FDA recommends the enhancement of the agency’s web-based public resources to provide ready access to meaningful, up-to-date device information.

    The FDA is also recommending improvements to the Center's current online database, so that it can serve as a searchable one-stop source for detailed information about cleared devices, including photographs and design schematics, summaries of FDA review decisions, and up-to-date device labeling. Such a database would allow prospective submitters to identify appropriate predicate devices and provide practitioners and patients with more comprehensive and current information to support the safe use of cleared devices.


  3. Seek rescission authority and clarify when a device should not be used as a predicate.

    Concerns have been raised that current FDA regulations allow for predicate comparisons that are insufficient to provide reasonable assurance that a device is safe and effective.

    The FDA recommends the development of guidance to identify situations in which a device should not be used as a predicate. In addition, the FDA recommends that CDRH consider issuing a rescission regulation.


Industry Burden

Professor Hall didn't buy Shuren's highlighted list and gave us his own list, based on the ten internal task forces' agenda. Hall evaluated the potential of these recommendations increasing industry burden.

  • Predicates - Increases
  • Indications - Increases
  • New Technology - Increases
  • De novo - Neutral
  • Evidence - Increases
  • Modifications - Increases
  • Standards - Neutral
  • Bundling - Increases
  • 3rd Party review - Increases
  • Postmarket data - Increases

Professor Hall's main complaint is that he sees the FDA's recommendations as increasing the burden on industry without increasing the level of safety of devices in any meaningful way. "The FDA clearly focused on perceived safety issues, ” says Hall.

Ralph Hall/reilly.nd.edu
Hall adds that many of the proposals lack specific language and express ideas without details. As such, the actual impact of the proposals is not certain. As an example he notes that the FDA is proposing multiple ways to limit the availability of predicates without defining what a "bad" predicate is or what administrative process would be used to make such a determination. 

For Hall, this reinforces the need for a second round of public input.

For now, we’ve learned the recommendations are addressing a nonexistent safety problem and will likely add a burden on innovation. That leaves recommendations to upgrade agency staff and streamline their own processes as the remaining ideas for increasing the predictability of the 510(k) process.

Click here to read the recommendations yourself. You’ve got until October 4, 2010 to let the agency know what you think.


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