Division of Docket Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
Comments of Members of the Patient, Consumer, and Public Health Coalition
on Draft Guidance
“De Novo Classification Process (Evaluation of Automatic Class III Designation)”
[Docket No. FDA-2011-D-0689]
As members of the Patient, Consumer, and Public Health Coalition, we have serious reservations about the use of the de novo classification process for implants, life-sustaining, and life-saving devices. We believe that all such high-risk devices should be Class III devices reviewed through the more rigorous PMA process. That is why we urge CDRH to revise the draft guidance to explicitly state when the de novo process may be used and when it cannot be used.
We strongly support language in the draft guidance that states the de novo process should be used for devices that are “low to moderate risk” (Class I or Class II devices). We also support language that states, “The de novo should include all (emphasis added) information and evidence regarding the safety and effectiveness of the device,” and “provide data demonstrating that general controls or general and special controls support a classification of Class I or Class II.” However, we urge the FDA to revise the second sentence to read: “provide publicly available scientific data and test results demonstrating that general controls…support a classification of Class I or Class II.”
We support the draft guidance section on “Supporting Protocols and/or Data.” It recommends that an applicant “Provide a summary of all performance and clinical testing” and that “the summary should include the objective of the testing, a description of study design, and a description of results.” If companies fail to provide this information, FDA should deny their de novo application. In the National Center for Health Research’s recent study of cleared 510(k) implants, researchers found companies provided no scientific data in 4 out of 5 recent 510(k) applications, because they either did not provide summaries or their summaries provided vague information such as “all required testing was completed and the results were satisfactory.” This is very disturbing since current law states that the summary must include “sufficient detail to provide an understanding of the basis for a determination of substantial equivalence.” 
Devices ineligible for de novo
We strongly support the following language that clearly states that a device is ineligible for the de novo process, if the “device falls under a class III classification regulation, or if it is a direct de novo and the device is not low-moderate risk, we [FDA] intend to decline your de novo.” However, we disagree with the restriction that a de novo review would not be considered “if a likely predicate device exists.” In many cases, implanted devices are listed as predicates even when they differ in size, shape, materials, or mechanism of action from new devices, and a de novo review would be a better choice than a 510(k) review.
The draft guidance states that if general and special controls are “insufficient to provide reasonable assurance of safety and effectiveness or…the data provided in the de novo are insufficient to determine…a reasonable assurance of safety and effectiveness, we [FDA] will decline the de novo and you may not legally market the device.” We are concerned about this wording, however, because the FDA’s definition of sufficient evidence is often very subjective and this has resulted in terrible harm to patients when based on assumptions that have proven to be incorrect, such as for Vena Cava filters (product code DTK).
Regarding the final sentence of the draft guidance, it states “All information posted to the FDA website will be redacted to protect any confidential commercial, trade secret, or personal privacy information.” FDA should delete the first word, “all” because the intent of the language is not to redact all information, which is how it currently reads. Moreover, we strongly urge the FDA to err on the side of transparency when redactions take place. In the past, information that is publicly available elsewhere has been redacted from documents by the FDA.
The de novo process should be used to strengthen the approval standards for low-to-moderate risk devices by replacing the 510(k) process. It should not be used to lower the approval standards for high risk (Class III) devices, which should always be reviewed through the more stringent PMA process. We strongly urge the FDA to revisit their classifications of many implants, 95% of which now go through the 510(k) process, according to recent research.1 We also urge the FDA to reconsider the Class II classifications of many other life-sustaining and life-saving devices that have also been cleared through the 510(k) process based on predicates that differ substantially from the new devices in ways that have clear implications for safety and effectiveness, such as surgical robotic systems that were cleared as substantially equivalent to surgical tools. To protect public health and ensure that medical devices provide a reasonable assurance of safety and effectiveness, the draft guidance must unambiguously describe when the de novo process may and may not be used to clear a medical device.
Annie Appleseed Project
Breast Cancer Action
Center for Medical Consumers
Connecticut Center for Patient Safety
National Center for Health Research
Our Bodies Ourselves
Center for Science and Democracy at the Union of Concerned Scientists
The Patient, Consumer, and Public Health Coalition can be reached through Paul Brown at (202) 223-4000 or at email@example.com
 Zuckerman D, Brown P, Das A (September 29, 2014). Lack of Publicly Available Scientific Evidence on the Safety and Effectiveness of Implanted Medical Devices, JAMA Intern Med.
 US Food and Drug Administration. Content and format of a 510(k) summary. 21 CFR 807.92.