Department of Health and Human Services December 23, 2021 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions.'' Computational modeling and simulation (CM&S) can be used in a variety of ways in medical device applications, including to perform ``in silico'' device testing or as part of software embedded in a device. This guidance provides a risk-based framework that can be used in the credibility assessment of computational modeling and simulation (CM&S) used in medical device regulatory submissions. The draft guidance is intended to improve the consistency and transparency of the review of computational modeling evidence. This draft guidance is not final nor is it in effect at this time.

The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of the draft guidance entitled ``Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.'' FDA recognizes that it will take time for device manufacturers, healthcare facilities, healthcare providers, patients, consumers, and FDA to adjust from policies adopted and operations implemented during the declared public health emergency (PHE) to normal operations. To provide a clear policy for all stakeholders and FDA staff, the Agency is issuing this guidance to describe FDA's general recommendations for a phased transition process with respect to devices that fall within enforcement policies issued during the COVID-19 PHE, including recommendations regarding submitting a marketing submission, as applicable, and taking other actions with respect to these devices. FDA is concurrently issuing a companion guidance to describe FDA's recommendations for this transition process with respect to devices issued Emergency Use Authorizations (EUAs) during the COVID-19 PHE. This draft guidance is not final nor is it in effect at this time.

The Indian Health Service published a Notice of Funding Opportunity in the Federal Register of November 4, 2021, for the Substance Abuse Prevention, Treatment, and Aftercare grant program. The notice was missing a section in the description of the required Project Narrative that applicants must submit with their application. The Project Narrative will have a fourth section added, Statement of Need, and the page limit for the Project Narrative increased from 15 to 17 pages.

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Technical Considerations for Medical Devices with Physiologic Closed-Loop Control Technology.'' Physiologic Closed-Loop Control (PCLC) devices are intended for automatic control of a physiologic variable(s) through delivery of energy or substance using feedback from physiologic sensors. PCLC devices may play an important role in reducing cognitive overload, minimizing human error, and enhancing medical care during emergency response and medical surge situations. This draft guidance provides technical considerations for PCLC technology in order to promote development and availability of safe and effective PCLC medical devices. This draft guidance is not final nor is it in effect at this time.

The Administration for Children and Families (ACF) is requesting a 3-year extension of the ACF Uniform Project Description (UPD) (OMB #0970-0139, expiration 2/28/2022). There are no changes requested to the form.

The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on Form FDA 3602 and Form FDA 3602A, on which domestic and foreign applicants certify that they qualify as a small business and pay certain medical device user fees at reduced rates.