Shortly after telling researchers to go virtual to keep their clinical studies going, the FDA has issued a new policy giving manufacturers some leeway in marketing their remote vital-sign-measuring devices.
This includes new uses of FDA-cleared connected electrocardiograms, electronic stethoscopes, thermometers, blood pressure monitors and other noninvasive devices. One of the agency’s goals is to expand the use of these technologies during the coronavirus outbreak to help get noninfected patients out of hospitals and clinics and free up resources.
“Allowing these devices to be used remotely can help health care providers access information about a patient’s vital signs while the patient is at home, reducing the need for hospital visits and minimizing the risk of exposure to coronavirus,” Principal Deputy Commissioner Amy Abernethy said in an agency statement.
These technologies can work for patients diagnosed with COVID-19 as well, the FDA said in its guidance, pointing to respiratory monitors and certain clinical decision support software functions that provide COVID-19 treatment guidelines.
The policy, limited to the duration of the public health emergency, details how the FDA does not intend to object to companies making certain changes in product indications, claims or functionality nor to limited hardware and software modifications.
The earlier agency announcement this week described how the FDA was aware that certain clinical studies—such as those requiring in-person site visits or procedures such as biopsies—may not be able to continue as planned in light of efforts to maintain patient and provider safety and contain the spread of the coronavirus. The FDA recommended that companies use telehealth programs, phone interviews and self-administration where possible.