FDA Seeks to Expand Access to At-Home Medical Devices

The U.S. Food and Drug Administration (FDA) is looking for ways to increase access to medical devices intended for use outside of traditional clinical settings, such as in the home. In a recent request for public comment, the FDA asked for feedback on how it can better support the development and availability of technologies like at-home diagnostics and digital health products.

The goal of digital healthcare is to lessen healthcare gaps by bringing devices directly to patients in their homes and communities, allowing patients an amount of care between appointments, monitoring in lieu of more frequent in-person visits, or simply more information and control over their own health metrics. The FDA’s pursuit into this area aligns with the Agency’s strategic priority to advance health equity so all patients can access safe, high-quality medical products regardless of demographics or location.

Specifically, the agency wants input on:

• How to facilitate regulatory review and availability of devices for non-clinical settings
• Design factors to optimize use of technologies in the home or design factors necessary to ensure uniform use across a variety of users
• Methods to foster remote clinical trials and local care models with digital health
• Processes and diagnostics that could potentially transition from hospitals to homes
• Strategies to improve access for diverse populations like non-English speakers, or those in remote locations

The public comment period ends on August 30, 2023. Comments can be submitted to the FDA docket at Regulations.gov under docket number FDA-2023-N-1956.

This request reflects the FDA’s commitment to empowering patients and supporting innovation. If you have perspectives to share on any of the agency’s questions, make your voice heard. Patient advocates, healthcare providers, device manufacturers, and any citizen stakeholders should consider weighing in – your insights could catalyze impactful changes in health equity and innovation.

At MedLark, we share the FDA’s commitment to enabling health equity through expanded access to regulated home use devices. We specialize in helping medical device and biotech manufacturers navigate the ins and outs of regulatory approvals and quality system regulations for innovative products. If expanding access to health technologies resonates with your organization like it does ours, please get in touch – we welcome the opportunity to collaborate.

Looking to market in Europe or the UK? Check out our articles on the EU Medical Device Regulation or the UK MDR!