FDA Releases Plan Intended to Improve the 510(k) Program; Plan Contains 25 Action Items to Implement During 2011

By Jeffrey K. Shapiro –

Yesterday FDA announced that the Center for Devices and Radiological Health (“CDRH”) intends to take 25 actions to improve the 510(k) program in 2011.  The full action plan and remarks from CDRH Center Director Jeffrey Shuren, M.D., J.D. can be accessed here.  Our brief summary of the plan is laid out below.

Guidance Documents

FDA says it will issue several guidance documents in 2011.  Our list of the most important:

• “Clarification” of when a device modification requires a new 510(k) submission, and which device modifications are eligible for a Special 510(k) (expected June 15, 2011).  Depending upon how this is implemented it could increase the burdens on industry.
• Streamlining of the “de novo” process (expected September 30, 2011).  This process is needed for lower risk devices that lack a predicate device but do not need the rigor of the PMA process.  In recent years, the timelines to de novo classification have ballooned.  Any steps to shorten the process will be welcome.
• Clarification on how to appeal CDRH decisions, including decisions to rescind a 510(k) (October 31, 2011).  Better information will be helpful, since the menu of available appeals processes and their associated requirements has created confusion.  However, right now there are no deadlines for the agency in the most commonly used appeals processes (e.g., supervisory appeal), and appeals can languish for months.  CDRH needs to improve the appeals process and adopt firm deadlines for their own decision making.
• Clarification of the 510(k) Paradigm, to provide greater clarity regarding when clinical data should be submitted for a 510(k), the appropriate use of multiple predicates, resolving discrepancies between the 510(k) flowchart and the Federal Food, Drug, and Cosmetic Act, and development of 510(k) summaries to ensure their accuracy (September 30, 2011).  All of this clarity could be helpful, or it could be a means of introducing greater regulatory burdens.  Time will tell.

Internal, Administrative, and Regulatory Matters

FDA is considering establishing a Center Science Council, enhancing staff/reviewer training, and developing a network of external experts, among other matters.  CDRH is also considering establishing a “Notice to Industry Letters” as a standard practice to clarify to manufacturers those changes in CDRH’s regulatory expectations, and it is also considering the implementation of a unique device identification system.  Most of these reforms are promising, but the implementation will tell the tale.

CDRH says it will issue a regulation by the end of this year to track transfers of 510(k) ownership.  This reform is long overdue.  Unlike PMA approvals, CDRH has never tracked ownership of 510(k) clearances.  The result has been uncertainty as to ownership, creating difficulties for industry, especially in contractual agreements.  A 510(k) clearance is an asset.  As with real estate assets, it is appropriate to have a system that accurately tracks ownership.

Referrals to IOM

The agency has postponed decision making on many of the more controversial issues, deferring to the review that the Institute of Medicine (“IOM”) will conduct later this year.  These include the agency’s rescission authority, post-market surveillance authority, establishment of a Class IIb, clarification on when a device should no longer be available as a predicate, consolidation of the terms “intended use” and “indications for use,” and the possibility of pursuing a statutory amendment that would provide the agency with authority to consider an off-label use when determining a device’s intended use.  It is possible that this is a “good cop, bad cop” situation, in which the IOM will recommend the most controversial and unpleasant changes.  Again, time will tell.