Must a lay summary be provided to the patient if the images from an examination are re-read by a physician not associated with the facility where the examination was originally performed and interpreted (e.g., if the patient or health care provider requests a second opinion from another facility)?

No, there is no requirement that a lay summary be provided to the patient when re-interpretations of images are done at a facility different from the facility that made the original interpretation. However, FDA strongly recommends that the second facility inform the patient requesting the second opinion of the results, especially when the second opinion differs from the initial results.