If You're as Disappointed with the 510(k) Process as Everyone Else Who Manufactures Medical Devices, Here Is Your Chance to Actually Influence the Process

On Tuesday August 31, 2010, CDRH will host a live webinar to discuss the details of both reports and respond to any questions and concerns raised by the medical device Community. Click:


The FDA is now seeking additional public comments and input on the reports, especially on implementation feasibility and on potential alternatives.  

Before You Can Help Yourself, You Must Know the Subject Well

The 1976 Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act, formally established jurisdiction by the FDA over medical devices, requiring premarket review and approval by the FDA by means of a 510(k) submission prior to any marketing of new products. Such review is for the purposes of making available to consumers devices that are safe and effective, and fostering innovation in the medical device industry. “The 510(k) process was originally intended to ensure economic parity between post-enactment and pre-enactment devices.” Riegel v. Medtronic, 451 F.3d 104 (2d Cir. 2006).

Thirty-three years after the Amendments and the birth of the 510(k), in September 2009, CDRH convened an internal 510(k) Working Group that began a comprehensive assessment of the 510(k) process, being charged with evaluating the 510(k) program and exploring actions CDRH could take to strengthen the program and to improve the constancy of its decision making, with a principal focus on actions the Center could take in the short term under its existing statutory authority. Another and independent assessment by the Institute of Medicine is expected to conclude in the summer of 2011. (Another recent CDRH Report is entitled “Volume II: Task Force Utilization of Science in Regulatory Decision Making Preliminary Report and Recommendations.”)

Two open meetings earlier in 2010, plus comments entered into the dockets of each group, provided significant input for the Reports.

What FDA Says It Is Trying to Achieve By the Review Process

FDA’s preliminary report identifies the following objectives and findings:


(1) Finding: There is insufficient clarity with respect to pivotal terms in the definition of “substantial equivalence.” Key pivotal terms at issue are “intended use” as distinct from “indications for use”, especially since “indications for use” could refer to the manufacturer’s proposed statement in the device labeling as well as the “Indications for Use” form required in the 510(k) submission. 

  • The CDRH recommends consolidating the concepts of “indication for use” and “intended use” into a single term, while maintaining flexibility for submitters and not inadvertently resulting in making the concept of “intended use” more restrictive.  
  • Another recommendation is that the CDRH consider pursuing a statutory amendment providing the agency with express authority to consider an off-label use, in certain limited circumstances. 
  •   Yet another is to more clearly distinguish between “different technological characteristics” and “different questions of safety and effectiveness.”


(2)  Finding: CDRH’s current practice allows for the use of some types of predicates that may not be appropriate. 

  • The CDRH should consider a regulation providing for fully or partially rescinding a 510(k) clearance
  • More guidance to the industry is needed on when a device should no longer be available for use as a predicate because of safety and/or effectiveness concerns.
  •  More guidance is also needed on appropriate use of more than one predicate:
    • when “multiple predicates” may be used; 
    • considering expressly disallowing “split predicates”; and,
    • clarifying the distinction between multi-parameter or multiplex devices, and bundled submissions.
  • Conduct additional analyses to determining the basis for the apparent association between citing more than five predicates and a greater mean rated of adverse event reports.


(3) Finding:  Although there exists an alternative regulatory pathway for devices that lack a clear predicate but whose risks do not warrant class III controls, (i.e., the process for Evaluation of Automatic Class III Designation, also known as the de novo classification process), this pathway, as currently implemented, is inefficient and has not been utilized optimally across the Center.

  • Revise existing guidance to streamline the current implementation of the de novo classification process and clarify its evidentiary expectations for de novo requests.
  • There should be presubmission engagement between submitters and review staff to discuss what information is needed by the staff, in lieu of an exhaustive 510(k) review.
  • Possibly establish a generic set of controls to serve as baseline special controls for devices classified into class II through the de novo process, augmented by additional device-specific special controls as needed.


(4) Finding: It is challenging for CDRH to obtain, in an efficient and predictable manner, the information it needs to make well-supported premarket decisions and assure that each new or modified 510(k) device is substantially equivalent to a valid predicate. There are concerns over unreported device modifications, lack of clarity in submissions, improper use of recognized standards, and incomplete information from submitters.

  • Revise existing guidance to clarify what types of modifications warrant, or do not warrant, submission of a new 510(k), and what modifications are eligible for a Special 510(k).
  • Consider requiring each manufacturer to provide regular, periodic updates to the Center listing any modifications made to its device without the submission of a new 510(k), and clearly explaining why each modification noted did not warrant a new 510(k).
  • Consider adopting the use of an “assurance case” framework for 510(k) submissions, i.e., a formal method for demonstrating the validity of a claim by providing a convincing argument together with supporting evidence, useful in structuring arguments that would help assure that top-level claims are credible and supported.
  •  Consider requiring a submitter to provide detailed photographs and schematics of the device under review, to assist the reviewing staff in understanding key features; further, consider entry thereof into the public 510(k) database to the extent the photographs and schematics do not contain proprietary information.
  •  Consider requiring a submitter to keep at least one unit of the device available for CDRH access upon request.
  • Clarify appropriate use of consensus standards and revise requirements for “declarations of conformity” with a standard.
  • Consider explicitly requiring submitters to provide a list and brief description of all scientific information on safety and/or effectiveness of a new device, information that is known to or what should be reasonably known to the submitter.
  • Develop guidelines generally defining a subset of class II devices, called “class IIb” devices, for which clinical information, manufacturing information, or, potentially, additional evaluation in the postmarket setting, would typically be necessary to support a substantial equivalence determination:
    •  potential candidates may include some implantable, life-sustaining
    •       devices, and/or life-supporting devices, which present greater risks
    •       than other class II device types (i.e., class IIa devices);
    •  a device may be reclassified as class IIb based on new scientific information;
    •  clarification should be made regarding when the CDRH will require clinical data in support of a 510(k) submission, and what type and level thereof;
    • explore greater use of its postmarket authorities and consider postmarket surveillance studies as a condition of clearance for certain devices;
    •  consider a unique device identification (UDI) system, and using “real-world” data that is anonymized data on device use and pooled outcomes from electronic health record systems for future submissions; and
    • clarify when submission of manufacturing process information is warranted.
    •  Clarify when it is appropriate to use CDRH authority to withhold clearance on the basis of a failure to comply with good manufacturing requirements when a serious risk may be presented in such case.


                       (5)  Finding: Limitations in CDRH’s information technology (IT) and knowledge management infrastructure and tools make it challenging for Center staff and 510(k) submitters to access meaningful medical device information that would support better-informed and more predictable decision making.

  • CDRH should take steps to enhance its internal and public information systems and databases to provide easier access to more complete information about 510(k) devices and previous clearance decision; consider adopting Standard Operating Procedures (SOPs) on developing product codes, developing a publicly available, searchable database including a verified 510(k) summary, clarifying statutory listing requirements for submitting labeling and for updating of labeling, and clarifying the updating the 510(k) database related to transfers of 510(k) ownership.


  • (6) Finding: Variations in the expertise, experience, and training of reviewers and managers, including third-party reviewers, may contribute to inconsistency or uncertainty in 510(k) decision making.
  •  CDRH should enhance training, professional development, and knowledge-sharing among reviewers and managers, in order to support consistent, high-quality 510(k) reviews.

(7) Finding: CDRH does not currently have an adequate mechanism to regularly assess the quality, consistence, and effectiveness of the 510(k) program.

  • CDRH should enhance its systems and program metrics to support continuous quality assurance.

What You Should Do Now

  •  Prepare for the August 31, 2010 Webinar by reading and understanding both this blog entry and the report.
  • Immediately determine your company’s position on the issues to be discussed during the webinar.
  •  Be prepared to ask specific questions of the presenters.
  •  Gather and submit your company’s feedback regarding the draft reports to FDA by no later than October 4, 2010.

The Report, Volume I may be obtained at:


The Report, Volume II may be obtained at:


Further information from the CDRH on the Reports, Basic Questions and Answers”, may be found at:


Article by:  Alfred J. Monte, Jr., W. Christian Moffitt, Anton Ness