Did you miss these important 2019 FDA medical device guidance documents?

FDA finalized its Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program guidance on May 7, 2019. Although it is largely similar to the 2017 draft version, there are some minor updates. FDA added a helpful table that lays out the method and timeframe for feedback by Q-Submission type (pre-submission, submission issue request, informational meeting, and study risk determination). Discussing waiver requests under 21 CFR 812.28 (related to FDA’s acceptance of clinical trial data gathered outside the U.S.) was removed from the Q-Submission Program scope and cybersecurity was added as an appropriate Q-Submission topic.

Device manufacturers currently designing a clinical trial or considering conducting a clinical trial may find FDA’s new draft guidance on Patient Engagement in the Design and Conduct of Medical Device Clinical Investigations useful. FDA acknowledges that patients have valuable insights when it comes to living with a disease including the treatment and management of that disease, which can be very useful to manufacturers when designing and conducting a clinical trial. Patient engagement may help mitigate some challenges associated with clinical trials including enrollment and retention, especially when protocols include lengthy follow up periods and/or frequent visits to the investigational site. By using a patient advisor, FDA believes these common challenges may be lessened.

The guidance covers many topics aimed at improving and encouraging patient engagement in clinical trials. It provides suggestions for engaging a patient advisor who can help with activities such as the informed consent documents, follow-up options, and providing input to help determine clinically meaningful endpoints.

FDA recommends involving a patient advisor in the early planning phases of the clinical investigation so that input can be incorporated into the protocol. The input from the patient advisor should be included in the final protocols and informed consent documents of an investigational device exemption (IDE) application so that FDA may review these as part of the IDE application. For ongoing studies, FDA recommends involving a patient advisor and the research coordinator to review and propose potential solutions.

With respect to how patient engagement with a patient advisor implicates a study’s institutional review board (IRB), FDA notes that these patient engagement activities involve interactions that are consultative or advisory in nature. Therefore, FDA wouldn’t generally consider these activities to constitute research and IRB requirements generally would not apply. In contrast, interactions between the patient and the investigator usually include collecting information as part of a research plan. These interactions are generally in the context of clinical investigations and therefore must satisfy the applicable FDA requirements.

FDA encourages patient engagement and recommends sponsors utilize the informational meeting through the Q-Submission Program in order to discuss patient engagement approaches.

FDA finalized its guidance on Annual Report for Approved PMAs on December 16, 2019. This final guidance document clarifies and expands upon the 2014 draft guidance on PMA annual reports. The final guidance recommends the addition of several columns in the annual report’s “changes table,” including type of change (design, labeling, manufacturing), description of the change, related changes, and why a change does not impact the safety and effectiveness of the device.

The guidance also provides some additional examples of rationales for device changes. Remember, annual reportable changes are limited to those that do NOT affect the device’s safety or effectiveness. Change summaries in PMA annual reports should be carefully drafted to ensure that the change is accurately captured and fully described, but you should avoid using language that implies that the change could have an effect on safety or effectiveness. Consider having your regulatory lawyer review annual report change summaries.

Change summaries that are disorganized or sloppily-written may raise a red flag with the FDA, resulting in questions, deficiencies, and awkward retrospective submissions and even present the prospect of an enforcement action.

If FDA believes that the changes reported in the annual report could affect the device’s safety or effectiveness, they will tell you submit the change in a PMA Supplement or 30-Day Notice—even though the change was already implemented. This is another reason why it is important to get the regulatory assessment right the first time—before the change is implemented.

On September 19, 2019, FDA issued a new draft guidance for its Safer Technologies Program for Medical Devices. The new voluntary program for certain medical devices and device-led combination products is expected to “significantly improve the safety of currently available treatments or diagnostics” and is intended for conditions that are less serious than those eligible for the Breakthrough Devices Program. Devices that are subject to review under PMA, De Novo classification request, or 510(k) submissions are eligible for the program.

The program supersedes the Expedited Access Pathway that was launched in 2015, and has been modeled on the principles of the Breakthrough Devices Program. The intent of this program is to “help patients have more timely access to these medical devices and device-led combination products by expediting their development, assessment, and review” while preserving FDA’s current statutory standards for “traditional” submission pathways (e.g., 510(k), PMA, De Novo).

There are two specific eligibility factors that must be met in order to be eligible for inclusion in the program:

1. The device should not be eligible for the Breakthrough Devices Program due to the less serious nature of the disease or condition treated, diagnosed, or prevented by the device; and
2. The device should reasonably be expected to significantly improve the benefit-risk profile of a treatment or diagnostic through substantial safety innovations that provide for one or more of the following:
   • Reduction in the occurrence of a known serious adverse event;
   • Reduction in the occurrence of a known device failure mode;
   • Reduction in the occurrence of a known use-related hazard or use error; or
   • Improvement in the safety of another device or intervention.

The draft guidance document goes into great detail regarding these factors as well as other considerations—including flexible clinical study design and prioritized and/or expedited review. At its core, this is another indication of FDA’s willingness to engage with industry and promote innovation.

If you have ever had to print and ship multiple voluminous premarket medical device submission to the FDA, you are likely thrilled about FDA’s recent Final Rule regarding electronic submissions and the corresponding guidance document, eCopy Program for Medical Device Submissions, that was issued on December 16, 2019. An “eCopy” is an electronic version of a medical device submission on a CD, DVD, or flash drive. Unlike other guidance documents, the FDA specifically states that this guidance does indeed contain “binding provisions” as it relates to standards, criteria for waivers, and exemptions per Section 745A(b) of the FD&C Act.

Under this new rule, only a single eCopy of the submission is required to be submitted to the FDA. Remember to include a signed hard copy cover letter with the electronic copy of the submission. FDA’s eCopy guidance document contains technical standards that should be carefully followed. If you fail to meet the eCopy technical standards, your submission will be placed on hold until a valid eCopy is received, resulting in a delay in your submission review. This transition to eCopy will likely save time and money for companies by eliminating the burden of printing, packing, and shipping paper copies of submissions to the FDA.