Imaging Systems Guidance

Navigating the Regulatory Pathway during a Global Pandemic

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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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