AdvaMed questions changes to FDA's premarket program
The Advanced Medical Technology Association (AdvaMed) has released a comment in regard to the FDA’s August report proposing changes to the medical device approval process, expressing concerns that timely access to safe and effective medical technologies for U.S. patients may be disrupted.
The comment—issued this month—supported a number of the FDA’s recommendations and highlighted others that the association supports with modifications or does not support.
According to AdvaMed, the response urged the FDA to move forward with changes to the premarket review program for low- and moderate-risk medical devices “in a way that builds on the strengths of the current program…. [and] could also improve the predictability and efficiency of the 510(k) process.” Specifically, the FDA “should focus on the proposals the agency has advanced that enjoy broad agreement,” including increased reviewer training, development of specific guidance documents and improvements to the de novo review pathway, the comment asserted.
According to AdvaMed, FDA recommendations that could present negative outcomes on medical innovation include:
• Redefining fundamental terms;
• Limiting use of predicates;
• Consideration of off-label uses; and
• Greater authority to rescind 510(k)s.
AdvaMed also cited concerns regarding the plan to establish a separate category of 510(k) devices – to be identified as “Class IIb” – that would be subject to additional regulatory requirements, noting that these proposed additional requirements for this category are “unreasonably burdensome.”
The association said it hopes to work with the FDA in the future to ensure clarity and efficiency of the premarket review program. “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,” the statement concluded.
The comment—issued this month—supported a number of the FDA’s recommendations and highlighted others that the association supports with modifications or does not support.
According to AdvaMed, the response urged the FDA to move forward with changes to the premarket review program for low- and moderate-risk medical devices “in a way that builds on the strengths of the current program…. [and] could also improve the predictability and efficiency of the 510(k) process.” Specifically, the FDA “should focus on the proposals the agency has advanced that enjoy broad agreement,” including increased reviewer training, development of specific guidance documents and improvements to the de novo review pathway, the comment asserted.
According to AdvaMed, FDA recommendations that could present negative outcomes on medical innovation include:
• Redefining fundamental terms;
• Limiting use of predicates;
• Consideration of off-label uses; and
• Greater authority to rescind 510(k)s.
AdvaMed also cited concerns regarding the plan to establish a separate category of 510(k) devices – to be identified as “Class IIb” – that would be subject to additional regulatory requirements, noting that these proposed additional requirements for this category are “unreasonably burdensome.”
The association said it hopes to work with the FDA in the future to ensure clarity and efficiency of the premarket review program. “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,” the statement concluded.