FDA allows modifications to coagulation monitoring systems for COVID-19

Regulatory NewsRegulatory News | 18 January 2021 |  By 

The US Food and Drug Administration (FDA) is allowing manufacturers to modify coagulation systems for measuring whole blood viscoelastic properties to allow for greater use in hospitals for the supportive management of patients with COVID-19.
The enforcement policy, which was issued in January 2021, is temporary and will remain in effort only for the duration of the COVID-19 public health emergency.
“As hypercoagulability has been observed in patients with COVID-19, FDA recognizes the importance and utility of increased availability of devices to test for and manage coagulopathies in patients in hospitals and other healthcare facilities, which are experiencing increased patient load due to the COVID-19 public health emergency,” the agency wrote in the 10-page guidance.
Coagulation systems that measure whole blood viscoelastic properties are typically used to flag changes used in assessing hemostasis before surgical procedures and in assessing bleeding and thrombosis after a traumatic injury, but the current policy would seek to expand their use for “the purpose of supporting and providing adjunctive patient management recommendations to the healthcare professional about treatment of COVID-19 or co-existing conditions.”
The policy applies to multipurpose systems for in vitro coagulation studies and coagulation systems for the measurement of whole blood viscoelastic properties, both considered Class II medical devices. The output for these systems consists of semi-quantitative results and a graphical display.
Currently, these systems have not been cleared or approved for use in hospital patient healthcare settings, according to the agency. Under the policy, the FDA will not object to limited modifications to the “indications, functionality, hardware, and/or software of the coagulation systems for measurement of whole blood viscoelastic properties” without prior submission of a premarket notification. The policy applies to modifications that would typically require a 510(k) submission to the FDA.
The agency will allow the following hardware and software modifications without premarket notification:
  • Expansion of indications to include hospitalized patients suspected of a COVID-19 associated coagulopathy.
  • A change in the indication for use to include hospital patient healthcare settings by trained healthcare professionals for viscoelastic devices previously cleared or approved only for use in hospital clinical laboratories.
  • Hardware or software modifications that support relocation of these devices to not previously reviewed or cleared hospital patient healthcare settings with testing performed by trained healthcare professionals.
  • Hardware or software modifications intended to reduce electromagnetic emissions in confined spaces to prevent electromagnetic interference with surrounding systems.
But the agency advised that the policy is not intended to allow manufacturers to make changes to the hardware or software that directly affect the measuring capabilities and functionality of viscoelastic devices. Additionally, the modified devices should not be used as the sole basis for making a clinical diagnosis or treatment decision about COVID-19 or coexisting conditions.
For manufacturers that do make modifications to coagulation systems under the enforcement policy, the FDA recommends that the devices be labeled to make the modifications clear to the user. The agency is recommending several labeling changes, including:
  • A detailed description of the changes including, which indications for use have been FDA-cleared or granted marketing authorization and which have not, changes to functionality, changes to hardware or software, new performance characteristics and new health risks, and instructions for mitigating known risks from changes.
  • Adequate instructions for use and indicated environments of use.
  • Minimum installation and qualification testing to be performed during installation.
  • Minimum post-installation inspection, calibration, testing, and maintenance to be performed.
  • A prominent and clear statement to both the patient and healthcare provider that results generated by the devices are supporting and should not be solely or primarily relied upon to diagnose or treat COVID-19 associated coagulopathy.
  • A prominent and clear statement that all results are intended to be interpreted by a licensed healthcare practitioner with the appropriate training.
  • A prominent and clear statement that the device is not indicated for the diagnosis of COVID-19.
  • A prominent and clear statement to the user that only appropriately calibrated pipettes should be used.
  • A prominent and clear statement that the device has been evaluated for interfering substances, such as antiphospholipid antibodies, and a list of any interfering substances that the device has not been tested for, if any.


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