- A slate of future FDA medical device regulations listed on the Office of Management and Budget's Fall 2018 Unified Agenda indicates a major effort by the agency to update its medical device application rules to adhere to the device center's priority to move to take a risk-based and least burdensome approach.
- FDA Commissioner Scott Gottlieb said the forthcoming regulations build on the agency's 2018 Strategic Policy Roadmap, and will focus on "outdated provisions that can add to development costs or forestall beneficial innovation without also enhancing device safety and effectiveness." Efforts include revamping the agency's De Novo classification process, amending the definition of a medical device to exclude certain medical software functions, harmonizing medical device quality systems with international standards and finalizing its proposed rule codifying procedures and timeframes of senior staff review of significant device center decisions.
- One proposed rule appears to be set to be published shortly: OMB is already reviewing a proposal it received Tuesday to update mammography regulations to incorporate best practices such as "addressing breast density reporting to patients and health care providers."
Gottlieb said the effort to update the mammography regulations first issued under the Mammography Quality Standards Act of 1992 will help FDA enforce consistent quality standards for mammograms by taking a more uniform nationwide approach to reporting requirements rather than relying on a "patchwork of reporting requirements that has been implemented in various states."
The OMB proposal estimates public health benefits will come in the form of earlier breast cancer detection, which it hopes will lead to lower cancer treatment costs. But it warns that the effort will hike industry labor costs and spending on testing and biopsies. The proposed rule is targeted for a November release.
Another anticipated proposed rule is FDA's plan to revamp the Medical Device De Novo Classification Process, which the agency pegs for release this month. The docket states that the proposal will "establish procedures and criteria for the de novo process and would make it more transparent and predictable for manufacturers."
Gottlieb said FDA's effort to amend the definition of medical devices in accordance with the 21st Century Cures Act, slated to be published in November, will help the agency focus on regulating products that fall within its purview.
"Digital health devices have the potential to improve our ability to accurately diagnose and treat disease, and to enhance the delivery of health care," Gottlieb said in a statement "These opportunities require us to explore ways to modernize our regulatory approach to better advance safe and effective innovation in this rapidly evolving area."
One interesting action by FDA is a plan to withdraw a proposed rule this month that would have required medical device establishments with certain home-use medical devices to electronically submit the label and package inserts for the agency to list publicly online.
The action comes after AdvaMed urged the government to withdraw the proposed rule, arguing it would confuse patients and be duplicative of labeling information on a manufacturer's website.
FDA also plans to discontinue publishing quarterly lists of premarket approval applications and humanitarian device exemption applications in the Federal Register. The agency said the effort is duplicative of its posting of the applications on its website and their availability through the Division of Dockets Management.
The agency is also targeting late 2019 for a proposed rule outlining its framework for over-the-counter hearing aids.