On October 30, CDRH finalized the guidance entitled, “Manufacturers Sharing Patient-Specific Information From Medical Devices With Patients Upon Request”. This is the final version of the guidance, “Dissemination of Patient-Specific Information from Devices by Device Manufacturers” issued in June 2016 (see our blog post on the draft here.)
We do not typically comment on guidance name changes from draft to final, but in this case the addition of “Upon Request” to the final guidance name marks a significant change from the draft to final guidance. The draft guidance contemplated prospective, unrequested dissemination of patient-specific information from medical devices. The final guidance, however, is limited to providing such information in response to a “request.” The guidance does not explain or define a request other than to say that a request could be directed to a patient’s healthcare provider or a device manufacturer.
The draft guidance was significant precisely because it allowed device manufacturers to share patient-specific data, including interpretive information, directly with patients without the communication being considered labeling or requiring a new premarket clearance or approval. The more limited scope of the guidance certainly tempers the importance of the guidance if providing data upon request will have a much more limited impact. The guidance highlights that patients are taking greater interest in and control of their health. However, patients are likely to request certain information only if they know of its availability. The guidance is silent as to whether a patient’s request can be solicited or not. For example, would this guidance still apply if a manufacturer posts on its website that certain information from its device can be shared upon request? Without specific restriction in the guidance, it appears the answer would be yes, unless FDA viewed this as improperly soliciting an unsolicited request.
In the draft guidance, the flow of information was from a device manufacturer to a patient directly. The guidance indicates that often times patient-specific information is accompanied by other explanatory text. If a healthcare provider could also be disseminating patient-specific information, it may be appropriate for device manufacturers to have a standard template for such communication. However, the guidance is silent on this point.
The definition of “patient-specific information” is relatively unchanged from the draft to final guidance. However, notably the final definition excludes the statement that the device information be “consistent with the intended use of the medical device.” The final guidance defines patient-specific information as:
information unique to an individual patient or unique to that patient’s treatment or diagnosis that has been recorded, stored, processed, retrieved, and/or derived from a legally marketed medical device. This information may include, but is not limited to, recorded patient data, device usage/output statistics, healthcare provider inputs, incidence of alarms, and/or records of device malfunctions or failures.
Like the draft guidance, the final states that interpretive information should be limited to “interpretations of data normally reported by the device to the patient or the patient’s healthcare provider.” To illustrate this point, the final guidance provides the following example as falling outside the scope of this guidance: “results of individual component tests for specific analytes that comprise or are utilized in a cleared assay but have not been individually approved or cleared to test for those specific analytes.” Thus, even though the “consistent with the intended use of the medical device” has been removed from the final definition, the remainder of the information continues to suggest that any patient-specific information provided should still be consistent with the intended use.
The final guidance, like the draft, emphasizes the need for providing comprehensive and contemporaneous information to patients, and manufacturers sharing such information should consider the content and context of the dissemination when responding to requests. The final guidance, interestingly, provides less guidance on these points than the draft. We expect that manufacturers seeking to provide patient-specific information will still have a lot of questions that are unanswered by this guidance before they start sharing information.