On Wednesday, January 19, 2011, the FDA released a plan to improve the current 510(k) program by announcing 25 action items "it intends to implement during 2011 to improve the most common path to market for medical devices." FDA identified these actions in its January 19th release after an almost 18-month review of the 510(k) program. Specifically, in August 2010, the Agency formed two working groups, the 510(k) Working Group and the Task Force on the Utilization of Science in Regulatory Decision Making, which were tasked with reviewing and proposing changes to the 510(k) programs to address "critical challenges facing the Center and [its] external constituencies." The Agency also said the numerous meetings with the public and industry stakeholders and comments submitted in response to the Agency’s proposed recommendations helped to inform the Agency’s final recommendations.

Importantly, however, the Agency’s identified action items do not provide specific details regarding any changes likely to be imposed over the coming months. Instead, the Agency’s recommendations signal that the real work of shaping modifications (or clarifications) to the 510(k) program is under way — modifications that will be articulated in guidance documents and policies. There will also be opportunities in the coming months to discuss additional areas of potential change to the 510(k) program in FDA’s proposed public meetings and topics of continuing evaluation. The Agency developed its action items by categorizing the 55 recommendations made by The Task Force and Working Group into three categories: (i) recommendations with strong support that translated into a specific action item for 2011 implementation; (ii) recommendations with support with a caveat or suggested modification that will be implemented in 2011 with consideration of the caveat or modification and (iii) recommendations with significant concerns that will remain on hold until the Agency receives the Institute of Medicine’s Report on the 510(k) Program.

Action Item: Wait and See

In presenting its recommendations, the Agency explained that the comments it received for some of its proposed recommendations suggested such strong opposition or concern that the Agency is essentially reserving a decision on final disposition of those recommendations for now. Because of the significant concerns raised by industry stakeholders, FDA stated that it intended to wait and see if the Institute of Medicine (IOM) addressed some or all of the most controversial of the recommendations. Specifically, IOM is conducting an independent evaluation of the 510(k) program and is expected to issue its report in mid-2011. Some of these "wait and see recommendations include:

  • Consolidation of the terms "indications for use" and "intended use" into a single "intended use" term
  • Issuing a regulation on FDA rescission authority
  • Expanding FDA’s authority to consider off-label use when determining the intended use of a device
  • Issuing guidance on removing a device from consideration as a predicate
  • Requiring manufacturers to keep one unit of a device available
  • Issuing guidance to create a "Class IIb" classification
  • Seeking additional authority to condition clearance of certain devices on required postmarketing surveillance studies

During a press conference announcing its action items, the Agency indicated that it had no plans to formally discuss the IOM’s review of the 510(k) program or these recommendations specifically. Although it is likely that the IOM report will address some, if not all, of these topics at least indirectly, there is no guarantee that it will do so. Moreover, industry stakeholders will need to monitor FDA’s reaction to the IOM report and what action, if any, the Agency signals it may take after the IOM report is released.

Action Item: Draft Guidance

Among the key action items the Agency intends to implement — and the anticipated dates of completion — are a series of draft guidance documents which will be intended to:

  • Streamline the "de novo" review process for certain lower-risk medical devices (September 30, 2011) Clarify when the Agency will require the submission of clinical data to support a premarket submission (September 30, 2011)
  • Clarify when changes to a cleared medical device warrant a new 510(k) and which modifications would be eligible for a Special 510(k) (June 15, 2011)
  • Clarify when the Agency will require the submission of photographs or schematics for internal FDA use only during the 510(k) review process (September 30, 2011)
  • Clarify the criteria for identifying "different questions of safety and effectiveness" and technological changes that generally raise such questions (September 30, 2011)
  • Clarify the appropriate use of multiple predicates to support a premarket submission (September 30, 2011)
  • Clarify the characteristics that should be included in the concept of "intended use" (September 30, 2011)
  • Resolve discrepancies between the 510(k) flowchart and the FDCA (September 30, 2011)
  • Improve the quality and performance of clinical trials (July 31, 2011)
  • Clarify the appropriate use of consensus standards (October 31, 2011)
  • Clarify the process for appealing CDRH decisions (October 31, 2011)
  • Expand available guidance on pre-IDE meetings and enhance the quality of pre-submission interactions between the industry and CDRH staff (November 30, 2011)

Although guidance documents do not create binding obligations on the FDA or industry, they are helpful because the represent the Agency’s current thinking on a matter. Moreover, the issuance of a draft guidance signals an opportunity for the Agency to provide comments and feedback to the Agency before the Guidance document is finalized. As a result, it will be important to monitor the FDA’s progress in issuing these draft guidance documents and providing the Agency with meaningful feedback in order to assist the Agency create meaningful Guidance that will help to achieve greater transparency and predictability in the Agency’s processes while fostering innovation in medical device technology.

Action Item: Draft and Publish FDA Policies

The Agency also intends to implement several internal or administrative matters that are intended to further support innovation, improve transparency and offer predictability in the review process. Included in these changes is the Agency’s plan to establish a Center Science Council within CDRH that would be tasked with oversight of the development of a business process and procedure for determining and implementing an appropriate response to new scientific information. The Center Science Council would also be tasked with auditing FDA’s 510(k) decisions to assess adequacy, accuracy and consistency. The FDA intends to develop and post the Council’s charter by March 31, 2011. The FDA has also stated that the Council’s first audit of 510(k) review decisions would be posted to FDA’s website by June 15, 2011. Significantly, FDA’s action items for the Council do not provide an intended timeframe for the Council developing an SOP for determining and implementing FDA’s response to new scientific information. This is one area, in particular, where the Council’s charter and additional information from FDA in the coming months regarding the Council’s tasks will warrant additional attention.

FDA’s intended action items also include the development and publication of several FDA internal policies and procedures in order to foster transparency and predictability. For example, the Agency intends to provide public access via FDA’s website to FDA’s policies for staff interactions and utilization of external experts by September 15, 2011. The Agency also intends to publish a policy on "Notice to Industry Letters" which will inform stakeholders when CDRH has changed its regulatory expectations on the basis of new scientific information. The SOP is intended to provide industry with insight on FDA’s process for issuing a Notice to Industry Letter and is designed to help eliminate some of the confusion regarding changes to FDA’s review requirements on a case-by-case basis. Another administrative matter that the Agency is working on is developing a network of external experts to appropriately and efficiently leverage external scientific expertise, including assessing best-practices and developing SOPs for staff engagement with external experts. FDA intends to develop and post these SOPs on its website by September 15, 2011.

Action Item: Evaluate and Discuss

The Agency’s intended action items include a number of items in which the Agency intends to continue seeking information and comments which, presumably, will inform future program modifications. For example, FDA is sensitive to challenges and inconsistencies in IDE decision making at the Agency. In order to improve the IDE process, FDA intends to characterize the root causes of these challenges and to identify trends in IDE decision-making. Concurrently, the Agency has identified that it intends to assess, characterize, and mitigate these challenges through an IDE program assessment. The Agency intends to complete this assessment by June 30, 2011.

FDA also intends to complete specific action items for improving the collection and analysis of postmarket information. By June 30, 2011, FDA has proposed to have determined the system requirements and selected the platform for creating a new adverse event database. The Agency hopes with this database to enhance its evidence synthesis and quantitative decision making regarding postmarket information.

In its action items, the Agency has also announced a public meeting on April 7-8, 2011 to discuss specific recommendations that it believes require additional feedback from industry stakeholders in order to effectively implement. Specifically, the Agency intends to discuss at the public meeting when and how it should make device photographs available in a public database in order to provide additional information about regulated products to the public while balancing the need to protect proprietary information. The second topic identified for the April public meeting is a discussion of FDA’s intent to develop an on-line labeling repository.

Action Item: Issue Regulations

FDA identifies three categories of proposed regulations that it intends to issue in 2011. The first regulation pertains to FDA’s implementation of a Unique Device Identification (UDI) System. A UDI System has been on-going and garnered much attention and industry discussion. Obviously, FDA’s proposed regulations will require much thought and comment by industry stakeholders to assist the Agency in implementing this System in a manner that is not overly-burdensome, protects proprietary information, and is cost-effective. The Agency intends to promulgate its proposed UDI System regulations by June 30, 2011. The Agency is also working to develop and issue proposed regulations on ownership transfers of 510(k) clearances and the statutory listing requirements for the submission of labeling. FDA intends to issue these regulations by December 31, 2011.

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Ultimately, the Agency’s released action items signal that there will be a continuing need to work with the Agency during the development, dissemination, and finalization of its anticipated Guidance Documents, policies, and regulations. There will also be a continuing need to work with the Agency regarding its continuing evaluation of the 510(k) program as the Agency contemplates additional modifications and clarifications.