Imaging Systems Guidance
Navigating the Regulatory Pathway during a Global Pandemic
What are the motivations for the COVID-19 Imaging Systems guidance?
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- 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?
What type of imaging system (Table 1) modifications are envisioned by the guidance?
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- 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?
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- 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?
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- 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?
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- 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?
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- 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?
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- 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?
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- 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?
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- 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?
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- 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?
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- 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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