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Aug 23 2010

CDRH Proposes Changes to the 510(k) Pathway

All for one, one for all, that is our device.

– Alexandre Dumas

The Center for Devices and Radiological Health (CDRH) has been somewhat under fire in recent years, so it surprised no one when it undertook a long look in the mirror in 2009.  With this period of introspection now complete, it has just published its preliminary findings and recommendations for public consideration and comment (Docket No. FDA–2010–N–0348; comments due 04 October 2010).

These will take some time to fully absorb, but the discussion is already well under way.  For example, the FDA Law Blog has a very nice write up of some of the recommendations.  I always suggest reading the primary source for yourself first, but because the full report is 177 (dense) pages (including the foreword), it may help to start by reading a few summaries before you really dig in.

The report is presented in two volumes.  The first is from the 510(k) Working Group; the second is from the Task Force on the Utilization of Science in Regulatory Decision Making.  Both committees are part of CDRH, so this is largely an internal evaluation, although some external input was also incorporated.

Without further ado, here are both the findings and recommendations of the committees [my comments in italics and brackets]:

Volume 1: 510(k) Working Group Preliminary Report and Recommendations

A Rational, Well-Defined, and Consistently Interpreted Review Standard

  • Finding: There is insufficient clarity with respect to pivotal terms in the definition of “substantial equivalence.” Recommendation: CDRH should clarify the meaning of “substantial equivalence” through guidance and training for reviewers, managers, and industry.  [I agree.  Who wouldn’t?  Establishing substantial equivalence for certain devices can be akin to reading tea leaves.]
  • Finding: CDRH’s current practice allows for the use of some types of predicates that may not be appropriate. Recommendation: CDRH should explore the development of guidance and regulation to provide greater assurance that any comparison of a new device to a predicate is valid and well-reasoned.
  • Finding: Although there exists an alternative regulatory pathway for devices that lack a clear predicate but whose risks do not warrant class III controls (i.e., the process for Evaluation of Automatic Class III Designation, also known as the de novo classification process), this pathway, as currently implemented, is inefficient and has not been utilized optimally across the Center. Recommendation: CDRH should reform its implementation of the de novo classification process to provide a practical, risk-based option that affords an appropriate level of review and regulatory control for eligible devices. [I completely agree.  The de novo process is, at best, baroque (pun intended).  Apply, then wait for certain rejection to apply for de novo classification.]

Well-Informed Decision Making

  • Finding: It is challenging for CDRH to obtain, in an efficient and predictable manner, the information it needs to make well-supported premarket decisions and assure that each new or modified 510(k) device is substantially equivalent to a valid predicate. Recommendation: CDRH should take steps through guidance and regulation to facilitate the efficient submission of high-quality 510(k) device information, in part by better clarifying and more effectively communicating its evidentiary expectations through the creation, via guidance, of a new “class IIb” device subset.  [Many companies have their own, shall we say, ‘unique’ ways generating 510(k) applications.  Creating standards would not be easy given how widely devices can vary from one another, but it would be well worth the effort.]
  • Finding: Limitations in CDRH’s information technology (IT) and knowledge management infrastructure and tools make it challenging for Center staff and 510(k) submitters to access meaningful medical device information that would support better-informed and more predictable decision making. Recommendation: CDRH should take steps to enhance its internal and public information systems and databases to provide easier access to more complete information about 510(k) devices and previous clearance decisions. [Yes please!]

Continuous Quality Assurance

  • Finding: Variations in the expertise, experience, and training of reviewers and managers, including third-party reviewers, may contribute to inconsistency or uncertainty in 510(k) decision making. Recommendation: CDRH should enhance training, professional development, and knowledge-sharing among reviewers and managers, in order to support consistent, high-quality 510(k) reviews.
  • Finding: CDRH does not currently have an adequate mechanism to regularly assess the quality, consistency, and effectiveness of the 510(k) program. Recommendation: CDRH should enhance its systems and program metrics to support continuous quality assurance. [This recommendation is fuzzy, but the intent is good.]

Volume 2: Task Force on the Utilization of Science in Regulatory Decision Making Preliminary Report and Recommendations

Enhancing CDRH’s Scientific Knowledge Base

  • Finding: Challenges related to CDRH’s current data sources, methods, and administrative practices make it difficult for the Center to efficiently and effectively obtain complete information about the risks and benefits of regulated products across the total product life cycle. Recommendation: CDRH should take steps to improve its ability to readily access high-quality information about regulated products.
  • Finding: Limitations in CDRH’s current staffing levels, training, and knowledge management infrastructure make it challenging to share scientific knowledge across the Center and to develop new knowledge from available information sources. Recommendation: CDRH should take steps, with existing resources, to address staffing needs and enhance processes and systems that support Center-wide integration.
  • Finding: It is difficult for Center staff to tap meaningful external scientific expertise in a timely manner. Recommendation: CDRH should improve its mechanisms for leveraging external scientific expertise. [In fact, it has already made several changes to the way device advisory committees function.]

Applying a Predictable Approach to Determine the Appropriate Response to New Science

  • Finding: There is a lack of clarity within and outside of CDRH about when new scientific information warrants certain types of action by the Center, particularly a change in premarket evidentiary expectations. Recommendation: CDRH should establish and adhere to as predictable an approach as practical for determining what action, if any, is warranted.

We’ll have to wait to see which recommendations CDRH formally accepts, but it’s clear that CDRH does not intend to sit around and ponder its navel now that this report is complete.  I’ll conclude with a quote from the foreword by CDRH Director Jeffrey Shuren to highlight the fact that CDRH is working hard in other arenas to improve both its processes and public relations.

“The actions proposed in these reports would complement two major steps CDRH is already taking, in collaboration with others in the federal government, to foster medical device innovation. We have established a new interagency Council on Medical Device Innovation, whose aim is to identify unmet public health needs and facilitate the development or redesign of devices to address those needs. In addition, FDA recently signed an information‐sharing Memorandum of Understanding with the Centers for Medicare and Medicaid Services (CMS), which will allow us to better coordinate the work of our two agencies. These efforts have the potential to dramatically streamline the process of bringing new safe and effective medical technologies to patients.”