Proposed Changes to the 510(k) Process: 10 Recommendations for Strengthening the 510(k) Program

For Medical Device

Recently released recommendations for changes to the Food and Drug Administration's (FDA) 510(k) clearance program for class II medical devices has been a hot topic within the medical device industry. The 510(k) notification process uses predicate devices that the Center for Devices and Radiological Health (CDRH) at FDA has previously cleared for market release through the 510(k) notification process. New devices submitted for clearance must show substantial equivalence to predicate (cleared) devices. Unlike the more restrictive premarket approval (PMA) process where the manufacturer must demonstrate reasonable safety and effectiveness (most often in combination with human clinical research trials) CDRH reviews documentation submitted as a 510(k) and determines if the device is substantially equivalent to a predicate device—and thus—cleared for market release. Of the roughly 4,000 510(k) submissions CDRH receives each year, it clears about 3,000 devices from some 1,500 firms.1

"...the 510(k) Working Group's challenge was to review the current 510(k) process and determine if there were enhancements that could be made to the Center's process for clearing 510(k)s..."

Having been influenced by the promptings from indstry and patient groups that changes would be beneficial and having grown sensitive to comments regarding devices that were cleared based upon equivalence to devices no longer on the market, devices cleared that were not found to be reasonably safe and effective, and inconsistent decision making, the agency conducted its own review of the 510(k) program. Dr. Jeffrey Shuren, Director CDRH, tasked two internal CDRH committees to review the 510(k) program: the 510(k) Working Group's challenge was to review the current 510(k) process and determine if there were enhancements that could be made to the Center's process for clearing 510(k)s while the Task Force on the Utilization of Science in Regulatory Decision Making's challenge was to review how to enhance predictability in the regulatory process and to review how science is used by the Center in its decision-making. Findings and recommendations were released in June 2010, by the 510(k) Working Group (volume I2) and by the Task Force on the Utilization of Science in Regulatory Decision Making (volume II2). Also, the agency commissioned an independent report from the Institute of Medicine that is expected to be released in summer 2011.

The volumes delivered by the two committees from CDRH provide high-level findings and recommendations with a subset of "how to" recommendations for each finding. Based on the recommendations in both volumes, Dr. Shuren, in a letter dated August 2010,2 and in audio conferences,2,3 listed three areas that form the core of the recommendations: A) Fostering Medical Device Innovation, B) Enhancing Regulatory Predictability, and C) Improving Patient Safety. Within these three areas, Dr. Shuren highlighted 10 recommendations that the Center sees as being particularly beneficial in strengthening the 510(k) program.

A. Fostering Medical Device Innovation

  • 1. Streamline the premarket pathway for lower-risk novel devices. In this recommendation, CDRH would "make major reforms in [its] implementation of the de novo process, including steps to streamline the process and clarify the Center's evidentiary expectations for de novo requests." These reforms would provide a "reasonable and effective template" for these lower-risk devices.
  • 2. Enhance science-based professional development for CDRH staff. In this recommendation, CDRH would "enhance training; professional development, and knowledge-sharing among Center staff, to assure that appropriate scientific expertise and regulatory experience are brought to bear in decision making." Training could include sending CDRH staff to "real world laboratory test beds" to enhance their understanding of new technology.

  • 3. Establish a network of external experts to better inform the review of cutting-edge technologies. CDRH would "develop a network of external experts using web-based social media technology. Such a network would allow Center staff to more efficiently and effectively leverage outside knowledge in order to answer important scientific questions, but would not serve in an advisory capacity." These external experts would understand advanced technologies. CDRH staff would be able to "ask scientific questions" of these experts and thus have a "better understanding of the technology as it's coming before the agency."

B. Enhancing Regulatory Predictability

  • 4. Increase the predictability of 510(k) data needs by establishing a new "class IIb." CDRH would "develop guidance to define, at least as a heuristic, a subset of class II devices called 'class IIb' devices, for which clinical or manufacturing information would typically be necessary to support a substantial equivalence determination. The development of a 'class IIb' guidance document would help clarify, up front, what information submitters should include in their 510(k)s, so that they can plan accordingly." Clinical or manufacturing information submitted with the 510(k) application for the new class IIb devices would not constitute large-scale clinical studies but rather if required, would have a smaller subset of patients or users, or may simply require an answer to a specific question. Splitting class II into IIa and IIb is similar to European regulatory classifications for class II devices.
  • 5. Create a new "Notice to Industry" tool to more rapidly communicate changes in premarket expectations. In this recommendation, CDRH would "begin to use standardized 'Notice to Industry' letters to quickly communicate to an affected sector of industry when we have changed in our regulatory expectations with respect to a particular group of devices, the general nature of the change, and the rationale for the change, generally as a precursor to more detailed guidance." As guidance documents take years to finalize, the "Notice to Industry" letters would be written in a few weeks, posted on FDA's website, and available for public comment.
  • 6. Clarify the meaning of key terms in the 510(k) "substantial equivalence" review standard to improve the consistency, transparency, and timeliness of the review process. CDRH would "more clearly define these terms in guidance and training for review staff and industry." CDRH is proposing to review and re-release guidance documents with consistent terminology.

  • 7. Establish a Center Science Council as a new governance model to assure quality and consistency in CDRH's science-based decision making. In this recommendation, CDRH would "establish a Center Science Council, comprised of experienced managers and employees and under the direction of the newly created Deputy Center Director for Science position." Under the direction of Dr. William Maisel, the Center Science Council will be responsible for "creating a new governance model for assuring quality and consistency in [CDRH] science based decision making."

C. Improving Patient Safety

  • 8. Require the up-front submission of more complete safety and effectiveness information to support the review of 510(k) devices. This would require manufacturers to submit in their 510(k) application "a summary of all scientific information known or that should be reasonably known to the submitter regarding the safety and/or effectiveness of the device under review." The summary information could also include publications pertaining to the technology or device under application. In addition, providing the summary would give the reviewer information upfront, which could eliminate delays in the clearance process due to questions that must be answered prior to the Center making a decision.
  • 9. Create a searchable online public database to provide more detailed, up-to-date medical device information to industry, the health care community, and patients. This recommendation would require that the Center "make major improvements to [its] current online 510(k) database, so that it can serve as a searchable one-stop source for detailed information about cleared devices, including photographs and design schematics, summaries of FDA review decisions, and up-to-date device labeling." This information would be beneficial to manufacturers to ascertain if another device could be used as a predicate. The FDA decision summaries are currently being developed. The summaries will include what the device was cleared for, the decision for clearance and evidence used to make the decision, and the justification for the clearance. In the current 510(k) process, draft labeling can be used in the application. With this recommendation, final labeling and periodic updated labeling would need to be provided to CDRH.

  • 10. Clarify CDRH's 510(k) rescission authority and the circumstances under which a device should not be used as a predicate. The recommendation concludes that CDRH "explore the development of guidance to identify situations in which a device should not be used as a predicate, such as when the device has been removed from the market because of safety concerns. In addition, to clarify the circumstances under which CDRH would exercise [its] authority to rescind a 510(k) clearance to remove an unsafe device from the market and preclude its use as a predicate, the 510(k) Working Group recommends that CDRH consider issuing a rescission regulation." Per Dr. Shuren, "29 percent of the 510(k)s submitted in 2009 cited a predicate that was no longer on the market." A new guidance document on use of predicates would outline what devices would not be appropriate for use in a submission. Rescission is not mentioned in CDRH regulations; however, per Dr. Shuren "agencies have implicit authority to revisit decisions." The 510(k) program has been in effect for around 30 years and during that time, about 100 device clearances have been rescinded by CDRH. A rescission rule was proposed in 2001 and CDRH will revisit the wording of that proposed rule to determine if new revisions are warranted.


  1. 510(k) Clearances. (n.d.). U S Food and Drug Administration Home Page. Retrieved October 28, 2010, from
  2. CDRH Preliminary Internal Evaluations. (2010, September 24). U S Food and Drug Administration Home Page. Retrieved October 28, 2010, from

  3. Audio: The FDA's briefing on proposed 510(k) revisions | MassDevice. (n.d.). Medical device news, information and jobs for New England and the world | MassDevice . Retrieved October 28, 2010, from

Claudette Kile has more than 20 years experience in the medical device industry and is a principal consultant for BMP Group (, a regulatory affairs and quality assurance consultancy.