Part 8: Imaging Systems Guidance | COVID-19

 

Imaging Systems Guidance

Navigating the Regulatory Pathway during a Global Pandemic


What are the motivations for the COVID-19 Imaging Systems guidance?

    • Leverage current mobile radiological products and facilitate imaging systems changes for portable use so patients can undergo such procedures without entering a large healthcare facility.
    • Enable updates to current image software that can provide radiological findings to healthcare professional for diagnosis of a specific condition or monitoring of disease state/severity.
    • Increase availability of imaging devices to ease the increased burden on healthcare systems.

What medical device types are covered by this guidance?

    • Table 1: imaging products (magnetic resonance, computed tomography, x-ray, mammography).
    • Table 2: ultrasound imaging systems.
    • Table 3: image analysis software or embedded as part of Table 1 or 2 devices.

What type of imaging system (Table 1) modifications are envisioned by the guidance?

    • Expansion of indications to acquire images in situations where no alternatives exist at a facility;
    • Changes that expand mobility, portability, or relocation of medical imaging systems;
    • Changes to protect the operator or patient;
    • Design modifications to improve the ability to clean, disinfect, and/or sterilize the product; and,
    • Material changes to components the change does not significantly degrade image quality, and hazards associated with the modifications are identified and mitigated by design and/or labeling.

What type of imaging system (Table 1) modifications are not covered by the guidance?

    • Reducing radiation shielding for patient/ operator without equivalent alternative;
    • Increasing radiation administered to the patient or result in insufficient image quality;
    • Reducing the ability to clean/disinfect portions of the device in direct contact with the patient; and
    • Changes that introduce new types of reconstruction algorithms.

What type of ultrasound imaging system (Table 2) modifications are envisioned by the guidance?

    • Changes to enable the use of ultrasound outside of its cleared environment of use.
    • Changes to enable the collection of images by healthcare practitioners who are not trained in sonography, under the guidance or supervision of a trained or licensed healthcare practitioner.
    • Addition of a lung scanning clinical application (and/or lung scanning pre-sets).

What type of ultrasound imaging system (Table 2) modifications are not covered by the guidance?

    • Changes that result in an increase of the derated global maximum acoustic output parameters;
    • Changes that result in a mechanical index that exceeds known safety limit; and
    • Changes to enable lay users acquire images without in-person healthcare provider supervision.

What Table 2 device modifications are not permitted?

    • The device is labeled or modified for use at a lower gestational age than the FDA clearance.
    • The device is labeled for over-the-counter sale directly to lay users.
    • The device is labeled for use by lay users under the direction of a healthcare provider.
    • The device applies an algorithm to transform a physiological parameter into a novel index or alarm that may aid a health care professional diagnosis of an obstetric condition.

What type of imaging software (Table 3) modifications are envisioned by the guidance?

    • Changes to enable the use of ultrasound outside of its cleared environment of use.
    • Changes to enable the collection of images by healthcare practitioners who are not trained in sonography, under the guidance or supervision of a trained or licensed healthcare practitioner.
    • Addition of a lung scanning clinical application (and/or lung scanning pre-sets).

What type of imaging software (Table 3) modifications are not covered by the guidance?

    • Changes indicating device can be solely or primarily relied upon to diagnose COVID-19;
    • Changes indicating device can be solely or primarily relied upon to triage COVID-19 patients;
    • Changes indicating device can predict treatment outcome/response in patients with COVID-19; and
    • Changes to distinguish COVID-19 from other lung diseases.

What is the envisioned validation of COVID-19 changes?

    • Designing, evaluating, and validating changes made to hardware, software, materials or duration of use should be done according to FDA recognized standards (Table 4).

What COVID-19 labeling updates does the FDA recommend for modified devices?

    • A clear description of the product modifications, performance and potential risks.
    • Adequate instructions for use for the intended user and indicated environment(s) of use.
    • The minimum installation and qualification testing to be performed during installation relocation.
    • The minimum post-installation servicing to sustain safe/effective operation of the modified product.
    • Distinctly delineate FDA-cleared indications and claims from those that are not FDA-cleared.
    • Include disclaimer that device recommendations should not be solely or primarily relied upon.
    • Statement that vitro diagnostic testing is currently the only definitive method to diagnose COVID-19.
    • Notice that all images should be interpreted only by a trained licensed healthcare practitioner.
    • Labeling consistent with most recent COVID-19 guidelines about imaging use by CDC or WHO.
    • Notice that user should be cognizant of start/local requirements for imaging systems use.
    • For all image analysis software (Table 3):
      • Specify that the image analysis should only be used as an aid and that final interpretation.
      • Specify that should not be used for screening, diagnosis, or patient management decisions.
      • Describe development dataset characteristics and limitations impacting generalizability.

What are acceptable temporary changes to the maintenance of imaging products?

    • Delay in repairing electronic defects/failures that are non-life threatening if the manufacturer notifies facility that it cannot access the system or having difficulty obtaining parts.
    • Delay in reporting of Accidental Radiation Occurrence Reports if manufacturers documents inability to identify the root cause due to limited access or communication with that facility.
    • Discontinuation of submission of FDA Form 2579 Report of Assembly of a Diagnostic X-Ray System to FDA by assemblers of diagnostic x-ray systems.
    • Discontinuation of report submission by manufacturers of diagnostic x-ray products.

 

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Gregory House spearheads innovation and technology at Syncro through exciting new initiatives. Greg earned a PhD in Electrical and Computer Engineer from Carnegie Mellon University and has a 20-year track record of commercializing digital technologies. He was Principal Investigator for $2 million in biomedical funding, awarded 14 US patents, and published 8 peer reviewed journal articles. His hands-on experience includes driving intellectual property strategy, building multi-disciplinary engineering and operation teams, and collaborating with research and medical institutions. Greg launched innovative products for health care and sports media into demanding real-world environments. He enjoys outdoor nature activities and serving the elderly and the community.

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