The Advanced Medical Technology Association (AdvaMed) urged FDA to move forward with changes to the premarket review program for low- and moderate-risk medical devices – known as the “510(k) process” – in a way that builds on the strengths of the current program. The association is concerned the number and scope of FDA’s recently proposed 510(k) changes could negatively impact the agency’s mission to ensure American patients have timely access to safe and effective medical technologies.
In comments submitted to FDA in response to the agency’s release in August of more than 60 proposals to change the 510(k) process, AdvaMed said that instead of implementing an extensive list of potentially disruptive proposals, FDA should focus on the proposals the agency has advanced that enjoy broad agreement, such as: increased reviewer training, development of specific guidance documents, and improvements to the de novo review pathway.
“Wholesale changes to a program that has such a strong record of protecting American patients while facilitating innovation and timely patient access to improved medical devices and diagnostics are not needed,” said AdvaMed President and CEO Stephen J. Ubl. “It is not in the best interest of patients to implement so many changes that it would likely overwhelm the agency and the industry, and have the effect of disrupting rather than improving an already effective program.”
In addition to increased reviewer training, specific guidance document development and improving the de novo pathway, in its comments AdvaMed supports a number of FDA’s recommendations and highlights many other proposals that, with modification, could also improve the predictability and efficiency of the 510(k) process.
However, AdvaMed also stresses that many of FDA’s recommendations could have a negative impact on medical innovation and the flow of improved products to patients while providing no corresponding public health benefits. For example:
· Redefining fundamental terms: AdvaMed notes that FDA’s proposals to help alleviate reviewer and sponsor confusion of some key 510(k) terms such as “substantial equivalence,” “intended use” and “indications for use” could significantly alter their meanings, add confusion to the process and increase delays in product clearances.
· Limiting use of predicates: Several agency recommendations to limit the type or number of predicates a sponsor could use to support the safety and effectiveness of their 510(k) would unnecessarily limit the range of evidence used in a submission and could unnecessarily complicate the review system for new medical devices.
· Consideration of off-label uses: FDA’s proposal for increased authority to consider an off-label use as the primary “intended use” of a device is troublesome, AdvaMed argues, since withholding clearance because the agency suspects a device will be used for an off-label purpose not sought by the sponsor could prevent needed technologies from reaching patients. FDA already has authority to deal with the inappropriate promotion of off-label uses and to require warning labels if needed.
· Greater authority to rescind 510(k)s: FDA currently has extensive post-market authority to remove a device from the market that it deems a danger to the public health without expanded rescission authority. AdvaMed is concerned that expanding FDA’s rescission authority could lead to more arbitrary removal of products from the market than under the current procedures. There could also be a significantly disruptive “domino effect” on the availability of medical devices, as the legal marketing status of devices that relied on the rescinded device as a predicate would be jeopardized – even if the concerns that prompted the rescission of the predicate do not apply to the subsequent devices.
AdvaMed also raised concern with FDA’s proposal to establish a separate category of 510(k) devices – identified as “Class IIb” – that would be subject to additional regulatory requirements.
“While AdvaMed supports identifying a small focused subset of Class II device types that would be subject to special requirements, we do not support the Class II b category as defined in FDA’s recommendations,” explains Janet Trunzo, AdvaMed’s executive vice president for technology and regulatory affairs. “FDA’s Class IIb proposal appears to include a much broader category of device types and the proposed additional requirements for this category are unreasonably burdensome.”
“AdvaMed looks forward to working with FDA and other stakeholders on ways to improve the 510(k) program that will increase the clarity and efficiency of the process but will not unnecessarily burden a process that has served American patients well for more than 30 years,” Ubl says.
A copy of the AdvaMed’s comments on FDA’s 510(k) recommendations is available here.