FDA Reform Train Is Full Steam Ahead: CDRH Lays Tracks for 510(k) System Changes

On August 4, 2010, FDA's Center for Devices and Radiological Health (CDRH) took the next step toward potentially vast reform of the 510(k) review process by releasing its preliminary internal evaluations and recommendations - potentially one of the most wide-ranging and substantial sets of changes in recent memory. Comments will be due by October 4, 2010. After reviewing the comments, FDA may proceed on some or many of the proposals, either by publishing detailed or lengthy guidance (potentially without further public involvement) or through the rulemaking process.

While several of these changes could be considered non-controversial consensus changes, others go beyond mere administrative changes and will require more deliberation, full Administrative Procedure Act rulemaking and even statutory changes before the recommendations can be implemented. Some of the proposals, such as improving the de novo process and enhancing reviewer training, may benefit patient and industry stakeholders by allowing faster, more predictable product reviews. Other proposals, such as the new "Class IIb" subset and a series of proposals to increase data requirements, may increase the burden on industry and innovators and further delay bringing new products to patients.

Highlights of the proposals under consideration by FDA include:

• Create a new Class II subset called "Class IIb" devices, intended to cover higher risk 510(k) devices. Devices reviewed under this class would generally need to be supported by additional clinical data and manufacturing data.
• Utilize a new "notice to industry" process to rapidly announce policy changes or new directions in regulatory expectations. These notices to industry would later be captured in subsequent guidance documents.
• Revise the de novo process to make it more timely and more predictable, and therefore serve as an alternative to the full-application PMA process.
• Tighten the use of predicates by banning split predicates, limiting multiple predicates and excluding the use of "bad" prior predicates.
• Clarify the definition of "substantial equivalence" and combine the definitions of "intended use" and "indications for use."
• Create a new cross-agency Center Science Council to improve scientific decision making and help resolve scientific issues.
• Improve FDA data bases, including posting of product pictures and schematics, and creating an electronic data base of all labeling.
• Create a process for rescinding 510(k)s.
• Create a social media network of external experts that FDA could use to stay current on new science and technology.
• Seek statutory authorization to be able to consider off-label uses in clearance decisions.
• Revise the 510(k) flow chart to better address when new intended uses and new technologies will require a PMA rather than a 510(k).
• Require companies to periodically submit a description of all product changes or modifications that were not submitted to FDA, and to provide an explanation as to why such changes did not require a new 510(k).
• Require companies to submit all known (i.e., "complete") scientific and clinical information with each 510(k).
• Enhance FDA's post-market authorizations along the lines of the PMA conditions of approval or the new drug REMS process.
• Enhance the training and education of FDA reviewers and staff.
• Revise the guidance on what is defined as "least burdensome."
• Require the submission of "assurance case" analysis as part of 510(k) submissions. (Assurance cases are a system to help ensure that claims regarding the product are accurate and complete.)