Stakeholders seek guidance, clarity from FDA on at-home medical technologies

Stakeholders from multiple industries want the US Food and Drug Administration (FDA) to reevaluate how it oversees at-home medical technologies compared to products used in traditional clinical settings. They also called on the agency to provide more clarity and predictability about its thinking, and to update and issue new guidances on the topic.

In June, FDA published a list of questions that it asked stakeholders for feedback on regarding at-home use devices. The issue is a priority for Jeff Shuren, director of the Center for Devices and Radiological Health, who hopes such technologies will help increase patient access to care and reduce healthcare costs. (RELATED: Shuren: At-home technologies must be fit-for-purpose, Regulatory Focus 16 June 2023)

The medtech lobby group AdvaMed provided an extensive list of recommendations, including asking the agency to define at-home use devices broadly. It noted that previous guidance from the agency defines such products as those that can be used outside a professional healthcare facility, which includes offices, schools, and independent living retirement homes.

AdvaMed also suggested several steps the federal government can take to increase access to treatments and diagnostics outside the clinical settings to address concerns about health equity. One example is to develop a network of community-based healthcare centers at places such as historically Black colleges and rural facilities.

“This network could also include community health facilities, clinical societies, community groups (e.g., church groups, beauty and/or barbershops), and patient or disease advocacy groups,” the group said.

AdvaMed noted that while doctor’s offices may not be considered nontraditional clinical settings, allowing doctors to administer in-vitro diagnostics (IVD) that they otherwise wouldn’t be allowed to administer would significantly increase FDA goal of increasing healthcare access.

“For instance, there is significant benefit to a patient that lives in a rural setting, in the ability to visit a local physician’s office, have the doctor’s office run the test, and obtain a result and clinical recommendations from the doctor in the same visit or very shortly after that visit,” said the group. “There is also a broader public health benefit to the extent that a patient with a communicable disease is identified more quickly.”

AdvaMed said FDA should broaden its definition of IVDs so that they are waived from requirements under the Clinical Laboratory Improvement Amendments (CLIA). Specifically, the group said allowing CLIA-waived testing at point-of-care (POC) settings such as doctor’s offices, mobile clinics and nursing homes can increase health equity.

AdvaMed also recommended that FDA reassess the standards for CLIA waivers and allow more flexibility and predictability in the studies that IVD manufacturers need to conduct to receive a waiver.

“Technology has evolved and is becoming easier to use,” said AdvaMed. “By contrast, obtaining CLIA waiver has been going in the opposite direction as expectations for CLIA waiver have increased with a resulting delay to patient access to tests in near-patient or POC settings.

“Our members have encountered significant challenges with the CLIA waiver studies,” the group added. “The metrics demonstrate that companies are reluctant to pursue these studies because even if they do everything right, it is unpredictable as to whether FDA will grant the CLIA waiver.”

To allow more flexibility and bring more certainty to the process, AdvaMed made a number of recommendations to FDA, including allowing flexibility in CLIA-waiver studies as long as the user is untrained, standardization of what is considered an untrained user and allowing companies flexibility in terms of the untrained user who is evaluated in the studies.

AdvaMed also recommended 510(k) devices traditionally used in clinical settings be reviewed under the Special 510(k) pathway if they have been modified for at-home use, and similarly, asked FDA to use its predetermined change control (PCCP) authority from Congress.

“For most devices FDA cleared/approved for use in a clinical setting, a change in use environment would necessitate a new marketing application, which is a time-consuming and costly process,” said AdvaMed. “To facilitate the timely expansion of devices to home use, and other non-clinical settings, we recommend FDA take an efficient and streamlined review approach for those devices that are already FDA-authorized for use in other environments.”

The group also said the agency should consider using several programs already available to achieve its goals and update several guidances to provide more clarity and predictability for companies planning to market at-home use devices.

The Medical Device Manufacturers Association (MDMA) made similar recommendations that FDA use the tools it already has, including the Special 510(k) pathway and expanding the Safer Technologies Program (STeP) to help get new home-use devices to market. The industry lobby group also recommended the agency use its breakthrough devices pathway for products used in non-clinical settings if they are for life-threatening or irreversibly debilitating conditions.

“In addition to leveraging existing authorities and tools during premarket review, FDA also should consider the use of its existing postmarket authorities in lieu of certain premarket clinical study requirements to facilitate earlier access to these important technologies while ensuring that the products achieve their anticipated risk-benefit profiles,” MDMA added. “Postmarket surveillance and real world data (RWD) and real world evidence (RWE) can provide additional evidence to support the risk-benefit profile of these technologies while reducing regulatory burden during premarket review and ensuring more timely access to devices in non-clinical care settings.”

In line with AdvaMed, MDMA also recommended FDA update its guidances to allow more at-home use devices on the market using a risk-based approach and develop new guidances as well as internal guidelines specifically addressing a product’s use setting. The group specifically asked the agency to reissue its 2014 guidance entitled, "Design Considerations for Devices Intended for Home Use," which could include updating its thinking on study design, patient participation, and digital health products.

“Adopting additional industry and internal Agency guidance reflecting a risk-based approach would increase transparency and predictability with respect to premarket review of devices intended for home use, and help to deliver on the promise of bringing important technologies into home use settings,” said MDMA. “New or modernized FDA guidance could also promote greater transparency and reduce burden on the Agency and other stakeholders through adherence to relevant established standards, including those of the American National Standards Institute (ANSI), the American Society for Testing and Materials (ASTM), and the International Organization for Standardization (ISO).”

MDMA, went on to recommend guidances that specifically address labeling of devices for at-home use products and address point-of-care environment questions. It also recommended that FDA should coordinate with other agencies, such as the Centers for Disease Control and Prevention (CDC) and the Centers for Medicare and Medicaid (CMS), on bringing such products to market.

While it was optimistic about how at-home use products could improve patient lives, the American College of Cardiology (ACC) also recommended FDA take a cautious approach. The physician group said social determinants of health need to be considered when allowing at-home use technologies on the market as such products could unintentionally contribute to further health inequities.

"The deployment of new tools comes with risks that could put patients in harm’s way and threaten the clinician-patient relationship that has been the central tenant of medicine," said ACC. "As the FDA and other federal agencies begin to examine ways to expand access to these at-home use technologies, it is essential that any regulations reaffirm, that the clinician, not the system/technology, is ultimately at the core of providing care to the patients.

"Clinical decision-making should still lay in the hands of the clinician and the patient, together deciding the best course of action based on what is best for the patient and the evidence available at the time," it added.

The Mayo Clinic said it's often hard to find devices that can be used in non-clinical settings because they weren't specifically designed for the home environment, to be operated by non-clinical users, or intended for diagnostic decision-making.

"While current FDA approval processes and regulations are effective at ensuring medical devices deployed within the walls of the hospital are safe and effective, we believe these same processes and regulations do not reflect the unique circumstances that at-home care providers are challenged with," said the Mayo Clinic.

"We feel that more guidance and regulatory rigor should be allocated to the data and interoperability functionalities of at-home devices," it added. "This would likely mean ensuring that sufficient data privacy measures are in place and that the device’s broadband functionalities work flawlessly and have redundancies for intermittent internet failure as opposed to stringent requirements and testing around infection risks."

The medical center went on to make several recommendations, such as reevaluating how FDA classifies medical devices, instituting validation protocols or issuing a guidance on how to validate at-home use products, and funding healthcare systems to implement at-home care systems.

“We believe that the difference between care delivered in the hospital and in the home is shrinking,” said the Mayo Clinic. “Using our Advanced Care at Home (ACH) model as an example, we deliver hospital-grade high-acuity care in the home that is just as safe and effective as care delivered in the walls of the hospital.”

Several drugmakers, including Pfizer, Otsuka and GSK, also commented on the issue. Echoing other stakeholders, they too asked for more clarity about how FDA plans to evaluate home-use technologies differently from those used in clinical settings and encouraged the agency to produce guidances on the topics. The pharmaceutical manufacturers stated they are especially optimistic about how digital health technologies can potentially revolutionize at-home patient care and asked the agency to make it easier for such technologies to come to market.

Besides asking FDA to streamline its premarket review process, Pfizer also recommended the agency adopt a fast-track pathway for promising digital health technologies and promote standardization within the sector. The drugmakers are also optimistic that at-home use digital health technologies can significantly help researchers remotely monitor patients in clinical trials.

"Digital health technologies (DHTs) have the potential to provide reliably matched and increasingly granular context to patient outcomes, including for example the time-of-day, weather, and pollen counts to cough/exacerbations tracking asthma trials," said GSK. "DHTs can improve trial data quality by enabling the collection and on-device storage of real-time patient outcomes data. The measurement and tracking of outcomes data can be designed to minimize subjective reporting by patients and HCPs, in favor of more consistent and objective measurement and tracking.

"FDA guidance in this space will be critical to ensure adoption of DHTs, including guidance on DHTs that can be used to capture digital endpoints, requirements for the use of digital biomarkers and DHTs, as well as FDA published lists of acceptable digital biomarkers," the company added.

The consumer retailer Best Buy also commented that it too sells products for patients to use at home and has partnerships with large health systems around the US to distribute products. An important part of its comments was on developing an effective payment model that gives patients access to such technologies.

"Currently, the payment models in place, such as the fee-for-service payment model, do not create an environment that is conducive to home-based care," said Best Buy. "The existing fee-for-service payment model directly limits the opportunities for home-based care—which is often designed to prevent more acute and expensive care—and instead incentivizes inpatient care.

"The policy changes the Centers for Medicare and Medicaid Services (CMS) implemented as part of its pandemic response, including remote patient monitoring and hospital-at-home, contributed to growth in digital health technologies (DHTs) and home-based care—generating cost savings and reducing readmissions," it added. "These policy changes should be continued and built upon going forward."

Stakeholders seek guidance, clarity from FDA on at-home medical technologies

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