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Reforming the 510(k) Process: Where We Are, How We Got Here, and What’s to Come

FDA moves forward with its plan to reform the 510(k) premarket notification process.


For a medical device to be marketed in the United States, it  must go through a regulatory process outlined by the Federal Food, Drug, and Cosmetic Act (FD&C Act) and enforced by FDA.1 For most moderate risk medical devices, the path involves clearance through the 510(k) process, named for section 510(k) of the FD&C ACT.2 In recent years, there has been dialogue between patients, healthcare providers, and policymakers in regards to the 510(k) process and the safety and efficacy of medical devices on the market. Additionally, with global pressures to innovate and compete, U.S. device manufacturers are concerned that changes to the 510(K) process could delay new device market entry.

FDA's Assessment

In response to this dialog, FDA began an assessment of the 510(K) process in September 2009 to improve the program. A working group was charged to explore actions by CDRH. It was comprised of representatives from across CDRH, consisting of 10 subgroups assigned a particular focus within the broader 510(k) framework.
The working group focused on strengthening the program and improving consistency of its decision making, with the principal focus on actions CDRH could take in the short term under its existing statutory authority to evaluate the 510(k) process. To that end, the working group analyzed how the current process operated, what challenges it presented for CDRH staff, and what steps the center might take to improve the program. The report from the working group was issued in August 2010. The findings focused on three major areas—a  rational, well-defined, and consistently interpreted review standard; well informed decision making; and continuous quality assurance.
The Working Group has issued or is planning to issue the following:
  • Draft guidance on changes to 510(k) cleared devices.
  • Draft guidance on the de novo Process.
  • Draft 510(k) Paradigm guidance.
  • Draft standards guidance.
  • Draft 510(k) transfer of ownership regulation.
  • “515 Program Initiative” to address all outstanding preamendment Class III device types subject to 510(k) review.
  • Total Product Life Cycle database.

Response from the Institute of Medicine

FDA asked for input from the Institute of Medicine (IOM), which focused its review on whether the current 510(k) process protects patients, promotes innovation, and If not, what legislative, regulatory, or administrative changes are recommended to best achieve the goals of the 510(k) process.
In July 2011, the IOM issued its findings that the current 510(k) process does not determine safety or efficacy,  lacks the legal basis to screen for safety and efficacy, and furthermore, was never intended to do either. In the area of innovation, the IOM found that the process does not require a device to be innovative and does not reward innovation, but that it can play a role in facilitating innovation by making devices available in a timely manner.
 The IOM recommended “rather than continuing to modify the 35-year-old 510(k) process, the IOM concludes that the FDA’s finite resources would be better invested in developing an integrated premarket and postmarket regulatory framework.”3

FDA's Next Steps

While none of the IOM’s recommendations are binding, FDA announced that it would open a public docket in July 2011 to begin receiving public comments on the IOM’s report on the 510(k) program. At the same time, the agency defended its decision to modify the current process rather than start from scratch as the IOM recommended, saying “the 510(k) process should not be eliminated but the FDA is open to additional proposals and approaches for continued improvement of our device review program.”4 

FDA has continued to move forward with its own plan to reform the 510(k) process as outlined in the 510(K) preliminary report.5 The main elements of FDA’s approach are the following:
  • Create new or update existing guidances for clarity.
  • Integrate systems and databases to make information more accessible.
  • Issue regulation to cover previously neglected items such as reclassified devices (515 Program Initiative) and transfer of ownership of a 510(k).

Figure 1: Regulatory Reform Timeline

Current State of Change

New Guidance: Changes to 510(k) Products.

The new draft guidance eliminates the flow chart, one of the industry’s most used tools. Additionally, comparisons of a device can now only be made to previously cleared versions of that device. When device changes require the manufacturer to submit a 510(k) for a change, it must use the previously cleared version of the device for the predicate. Previously, if a company were to submit a new 510(k), it could use any cleared device for the predicate. Another change is that the new guidance does not allow limiting the indications for any reason beyond marketing or it will be considered a substantial change. Lastly, the new guidance added a section on manufacturing process change.

New Guidance: De Novo Process.

Besides the original de novo request after not substantially equivalent (NSE) pathway, the new draft guidance creates a second pathway, pre de novo submission followed by 510(k). The pre de novo submission brings FDA in from the beginning, instead of after NSE determinations, which many companies with innovative products were already doing. Device manufacturers will likely benefit from the new pathway, because the defined process will no doubt enhance communication between industry and regulators. In addition to the new pathway, the guidance provides greater definition and more fully explains the FDA review process. These changes suggest a more consistent result for future submissions.

In addition to the new pathway, the new guidance provides greater definition and more fully explains FDA review process. These changes suggest a more consistent result for future submissions.

515 Program Initiative.

When FDA’s medical device regulation program began in the late 1970s, FDA regulated more than 100 Class III device types through the 510(k) program. The intent was that FDA’s regulation would be temporary and that over time, the agency would decide to reclassify those device types (or regulations) into Class I or II, or to sustain the classification in Class III and call for PMA applications.7
As of 2009, 26 out of 100 medical device regulations remained in the transitional state of class III designated 510(k) pending reclassification. In late 2009, FDA kicked off the 515 Program Initiative to facilitate the final adjudication of these remaining Class III device types with targeted completion end of 2012.6 An example of one of the 26 device types is pacemaker programmers, classified under 21 CFR 870.3700, with product code KRG.

Total Product Life Cycle

The total product life cycle (TPLC) database combines data to present an integrated record of premarket and postmarket activity for medical devices. The databases included in TPLC:

  • Premarket approvals (PMA).
  • Premarket notifications (510(k)s).
  • Manufacturer and User Facility Device Experience (MAUDE).
  • Recalls of medical devices.
  • Device classification.

The TPLC database integrates data by product code, so only datasets containing a procode are included. The TPLC reports include counts of the database information (see Figure 2). Details about which events were counted are available through links on the pages. As the various data sources are updated or refreshed, these counts may change.

Manufacturer names continue to provide a challenge. Firm names are subject to changes, and it’s not unusual to find inconsistent spelling or abbreviations in the MAUDE database. To aggregate the information in the TPLC, all firm names have been simplified and consolidated. As the data in MAUDE improves, firm names will become the firm name in the registration database as well.

Figure 2: This is a screenshot of a TPLC report for cable electrodes. Cable electrodes are 510(k) exempt, which is why the “premarket reviews” section is brief.

510(k) Paradigm Guidance

On December 27, FDA released “The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]” that fulfills their intent to provide a draft 510(k) Paradigm Guidance.7

Given that the vast majority of medical devices come to market through the 510(k) process, changes to this process are the most impactful for the industry. The draft guidance provides greater clarity regarding both the process of equivalence determination and the expected content for a 510(k). The guidance also specifies that FDA intends to verify the content of a 510(k) summary for accuracy and completeness and will require updates if further information is submitted for review.

Appendix B of the document is devoted to defining the requirements of the 510(k) summary.

The draft guidance addresses many of the industry’s concerns regarding the 510(k) process, mainly the lack of predictability and transparency. The process of determining substantial equivalence (or not) is detailed step by step in the body of the draft document, including specific examples, then pulled together via flowchart in appendix A, which includes reference back to both the relevant section of the draft document and to the applicable regulation. The draft document explains the appropriate use of multiple predicates, introduces a new term “reference device”, and establishes principles for determining new intended use.

Another commonly expressed concern is that companies are unclear when FDA will require clinical data for submissions. According to section IV.F, FDA uses a “stepwise analytical approach” to showing equivalency: descriptive information is considered first, then non-clinical performance testing, then clinical testing when other data is insufficient to show equivalence. Although this information is vague, there are several examples included that demonstrate instances when FDA might request clinical data.

By documenting the process in such a descriptive way, this draft guidance allows industry insight into what the reviewers are looking for and will hopefully provide for a reduction in the amount of requests for more information received by the industry.

Anticipated Steps

Standards Guidance. The standards guidance is intended to provide clarity and consistency in the application of standards. The release date is unknown.

Draft 510(k) transfer of ownership regulation. Currently, FDA is not involved in transfers of ownership; a 510(k) may be bought, sold, or transferred by companies.8 Due to lack of official documentation, the buyer obtains a warranty from the seller that the seller owns the 510(k) and has not previously sold / transferred it to another party. Inadequate record keeping can cause legal issues. The purpose of the new regulation is to better document 510(k) transfers of ownership. The recommendation from the 510(k) working group was that the center should update its 510(k) database in a timely manner when a transfer of ownership occurs.9 Currently, the 510(k) database reflects who submitted the 510(k) initially, and this inaccuracy is perpetuated by the TPLC report.

The release date is expected shortly.

FDA and Innovation

FDA launched an Innovation Initiative in response to concerns from the medical device industry that modifications to the 510(k) process would negatively impact innovation because of increased time and cost as well as the need for time-intensive clinical evaluation. The Innovation Pathway is a priority review program for new, breakthrough medical devices and is intended to strengthen the nation’s research infrastructure for developing breakthrough technologies and advancing quality regulatory science.

The Future: Reading the Tea Leaves

Given the release of the “The 510(k) Program” document, it is clear that FDA is standing firmly behind the 510(k) process and is committed to its ongoing improvement. Although the released guidances are in draft form, we anticipate that FDA will apply these guidances immediately.

As time unfolds, we expect this reform to have the following effect:

  • A higher standard for the selection of the predicate device.
  • A higher standard for claiming substantial equivalence.
  • Limitation on the use of split predicates and multiple predicates.
  • Greater use of the de novo process.
  • Higher probability of a NSE determination.
  • Greater consistency and predictability of the process.
  • FDA’s willingness to continually review and improve the 510(k) process is a critical part of its ongoing mission to provide American patients with safety, efficacy and innovation in medical devices.


Chris Henza is a regulatory affairs specialist with Regulatory Compliance Associates Inc. Geoff Hutchins is a senior program director, medical devices with Regulatory Compliance Associates, Inc. 

Image source: iStockphoto

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