Industry Seeks Greater Clarity on De Novo Classification Process

Devicemakers are urging the U.S. FDA to clarify its definitions of risk levels and what qualifies a medical device for de novo process in draft guidance on the approval pathway.

As currently written, the agency’s definition of “low to moderate” risk is vague and open to interpretation, the Orthopedic Surgical Manufacturers Association says in comments on the draft. “It would be useful for a sponsor to know FDA’s threshold for what could be a low-moderate risk device and what is a high-risk device,” the group says.

Increasing clarity around de novo criteria could save both the FDA and sponsors time and resources by eliminating submissions that are doomed to fail, OSMA adds.

The trade group also asks the FDA to provide examples of what it expects to see in the way of benefits with a de novo device, since traditional 510(k)s tend to focus on risks rather than benefits.

Practical Examples

AdvaMed recommends adding practical information and examples of issues that can hurt a de novo submission’s chances of approval, to aid sponsors considering this pathway. Given the relatively low number of applications that succeeded in getting a de novo classification, there may not be a strong incentive to apply, AdvaMed says.

The group also wants the FDA to clarify the criteria it uses to determine whether a de novo submission for a device previously found to be not substantially equivalent to a predicate will be granted de novo status or placed in Class III.

AdvaMed suggests adding a “scope” section as well to clarify that in vitro diagnostic products are included under the guidance. OSMA and AdvaMed were among 16 organizations and individuals that commented on the August 2014 draft guidance.

In its guidance, the FDA encourages presubmission meetings between devicemakers and the agency and warns that applications filed without a presubmission meeting will be more closely scrutinized. The agency will be looking to see that the sponsor’s search for a potential predicate was thorough, that it identified any risks and special controls that might be needed, and that it collected sufficient data to support claims of safety and effectiveness.

Members of the Patient, Consumer and Public Health Coalition on Draft Guidance expressed concern that the de novo process could be used to lower premarket standards for high-risk devices. “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,” the group says.

The de novo route is available to novel technologies that are not considered high risk and not the subject of a pending 510(k) or PMA.

View the draft guidance at www.fdanews.com/ext/resources/files/08/08-18-14-denovo.pdf. The comments can be accessed at www.regulations.gov/#!docketBrowser;rpp=25;so=DESC;sb=postedDate;po=0;dct=PS;D=FDA-2011-D-0689. — John Bechtel