On January 19, 2011, FDA released its “Plan of Action for Implementation of 510(k) and Science Recommendations.” See http://tinyurl.com/6hsd43h. This plan announced that the Center for Devices and Radiological Health (CDRH) intends to take 25 actions to improve the 510(k) program in 2011. This plan is the outgrowth of two internal working groups set up by CDRH in September 2009 to address industry concerns that the 510(k) process was too unpredictable, inconsistent, and not transparent enough, while also addressing concerns from consumer groups that the process was not robust enough to protect patients. At the same time CDRH undertook this review, it also asked the independent, nonprofit Institute of Medicine (IOM) to study the program. IOM's review is still underway. While these actions should provide guidance in several important areas, they also may place significant new burdens on the industry that may not be well received.
The Plan states that between June and December 2011, CDRH will issue eight new guidance documents. The most significant of these are:
- Issuing new clarification of when a device modification requires a new 510(k) submission, and which device modifications are eligible for a Special 510(k) (June 15, 2011). Though additional guidance is needed in this area, industry concerns are that the guidance may require industry to file additional 510(k)s not required under current guidance.
- Streamlining the de novo process for lower-risk devices that lack a predicate but do not require a PMA (September 30, 2011). The current process is very lengthy, and the hope is this guidance will shorten the time needed for the process.
- Clarification of the 510(k) Paradigm to provide greater clarity regarding when clinical data should be submitted to support 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). This guidance, while potentially helpful, may lead to increased burdens on industry.
- Clarification on how to appeal CDRH decisions, including decisions to rescind a 510(k) (October 31, 2011). Because there are currently no timeframes for CDRH to deal with appeals, such efforts often drag on too long.
FDA also has proposed the issuance of three new regulations before the end of the year:
- A rule regarding implementation of a Unique Device Identification system, designed to permit the rapid and accurate identification of device to facilitate and improve adverse event reporting and device specific problems (June 30, 2011).
- A rule to track transfers of 510(k) ownership (December 30, 2011). Currently 510(k) holders are not required to notify FDA when they transfer ownership though, in practice, many often do. This should ease the process and provide FDA with a mechanism to process such transfers.
- A rule to clarify the statutory listing requirements for the submission of labeling (December 31, 2011). This regulation will likely require manufacturers to submit current labeling as part of their annual listing submissions.
Though the proposals that CDRH has indicated it intends to issue are significant, the plan also defers a number of the most controversial proposals, including:
- A recommendation to seek greater authority to require post-market surveillance as a condition for clearance of some devices
- Instituting a new IIb classification for devices in which clinical or other information would typically be required to demonstrate substance equivalence
- New authority for FDA to consider “off-label” use when determining the “intended use” of a device
- Defining the scope and grounds for rescinding a 510(k) clearance and/or to clarify when a device should no longer be permitted for use as a predicate
With respect to these more controversial proposals, FDA intends to wait until IOM issues its review later this year. Despite this deferral of certain proposals, it is clear that CDRH has publicly announced an aggressive schedule that has the potential to alter the regulatory landscape in significant ways. Key to these proposals is whether these will ease the regulatory burden for industry or create new hurdles. Though time will tell, that time is coming quickly.