Advancing Policies to Promote Safe, Effective MedTech Innovation Posted on December 11, 2017 in FDA Voice by Scott Gottlieb, M.D.: “Early in the coming year, FDA’s Center for Devices and Radiological Health (CDRH) intends to advance several important new regulatory policy initiatives to further modernize the medical devices program and continue to foster new medtech innovation…” Cited were the following:
“New Steps to Reform, Modernize 510(k) Review
To address these challenges, in the first quarter of 2018, FDA intends to publish a draft guidance outlining a voluntary, alternative pathway for demonstrating substantial equivalence. This pathway will allow more flexibility to use more modern criteria as the reference standard, and permit comparisons to standards that more closely approximate the kind of novel technology we’re being asked to evaluate.”
“New Framework to Balance Pre- vs. Post-Market Requirements
For all medical devices that are subject to premarket review – whether through a premarket notification, premarket approval application (PMA), humanitarian device exemption application (HDE), or other type of marketing submission – FDA must determine whether probable benefits to health from use of the device outweigh any probable risk of injury or illness from its use. As part of that analysis, FDA considers what level of uncertainty is acceptable about the product’s probable benefits and risks before the device is available to the public. To fully discharge any uncertainty, FDA requires post-market follow-up studies. These studies are a way to fully elucidate the long-term performance of new medical products.
But the balance between acceptable uncertainty in the pre-market setting, relative to a product’s benefits and potential risks – and, in turn, how much reliance FDA can place on post-market follow-up studies – has never been objectively defined in one, comprehensive policy framework.
FDA intends to publish a draft guidance, again in early 2018, setting forth factors that the agency may consider when assessing acceptable uncertainty. The guidance will outline how certain issues could be ultimately resolved in the post-market setting, rather than the pre-market setting, to allow patients to gain faster access to potentially life-saving devices, when appropriate. Under this form of more progressive review, FDA will outline how it makes judgments about when it’s appropriate to place greater reliance on post-market data in order to facilitate access to certain innovation, or when the agency needs to rely more on pre-market data collection because of certain issues related to a particular product or how it may be used.”