The United States Food and Drug Administration (FDA) has published four medical device guidance documents. The new guidelines cover brain-computer interfaces, considerations in the design of medical devices for the magnetic resonance imaging environment, clinical studies for devices intended to improve glycemic control, and pre-release notification submissions. in the market for peripheral atherectomy devices.
The four documents, one in draft form and three in final form, were part of a wide range of guidelines announced by the FDA on Wednesday. Federal Register.
Implanted brain-computer interfaces
The first final advice FDA’s Center for Devices and Radiological Health (CDRH) provides device developers with clinical and non-clinical considerations on clinical and non-clinical testing of implanted brain-computer interface (BCI) devices for use by patients with paralysis or amputation. These devices, the FDA explains in the guide’s introduction, are “neuroprostheses that interface with the central or peripheral nervous system to restore motor and / or sensory skills lost in patients with paralysis or amputation.”
These guidelines were made available in draft form in February 2019; he initiated the FDA’s leapfrog process. Scott Gottlieb, Commissioner of the FDA at the time the draft guidelines were published, Explain then that the BCI draft guidelines “help bridge where we are today with tomorrow’s innovations, by providing our initial thoughts on regulatory considerations for emerging health technology, with the understanding that our recommendations are subject to change as the FDA works to finalize the guidelines for reporting for public comment, technology developments, and new information. ” (RELATED: CDRH publishes guidance on brain-computer interface devices, regulatory guidance February 22, 2019)
In the period since the publication of the draft guidelines, the FDA has taken into consideration the comments it received and made some adjustments to the final guidelines. Among these is the addition of a section dealing with human factors that recommends early and iterative attention to usability information; the final guide also describes training in the home use of implanted BCIs, including how to assess the effectiveness of the training.
The final guide also advises developers to submit a pre-submission to receive FDA comments when developing “any BCI device with technological characteristics, components or indications for use or a patient population not described in the guide.”
The 30-page guidance document guides developers through the considerations in the investigational device pre-submission and exemption processes, paying particular attention to non-clinical benchmarking considerations. An appendix provides stimulation output specifications.
The guide strongly encourages developers to take advantage of FDA feedback early in the development process of BCI through the agency. Q Submission Program.
Safety in the magnetic resonance environment
The FDA also finalized advice on controlling and upgrading medical devices for safe use in the magnetic resonance environment. The strong magnetic forces used in magnetic resonance imaging (MRI) and other MRI work can lead to disaster if the ferromagnetic materials get too close to the magnets. (RELATED: FDA Updates Guidelines for Devices in the Magnetic Resonance Environment, Regulatory Focus 01 Aug 2019)
After reviewing the consensus standards and relevant guidance documents, the final guidance explains how to deal with a variety of hazards that medical devices may present in the MR environment. These range from magnetically induced moving force and torque to unintentional heating, gradient induced vibration, unintentional stimulation, and medical device malfunction.
The final guide clarified the approaches to be used to assess radiofrequency heating; other revisions provided more detail “on when the gradient-induced vibration and heating estimates are needed and to include the possibility that the magnetically induced force and torque cause the equipment to tip over” , according to Federal Register Entrance announce the availability of the final guide.
The guide also explains how to assess the artefact or MR image corruption that active operating medical devices can cause; another section explains to developers how to report the results of their tests.
For MRI safety labeling of devices, the FDA defines four categories: MR Safe, MR Unsafe, Conditional MRI, and a final category for devices whose MRI safety has not been assessed. Developers wishing to use the latter category should “explain why the labeling is appropriate for your medical device in your pre-market submissionâ€; a Q-submission engagement with the agency is also recommended if developers are unsure whether this category best fits their device.
The final 23-page guide is accompanied by two appendices; the first gives an example of a summary of test results that could be included in a regulatory submission, and the second gives examples of conditional RM labeling. The new RM analysis and labeling guide replaces a 2014 guide.
Pre-market submissions for atherectomy devices
The FDA also finalized a 2018 draft guideline that contained selected updates for pre-market notification submissions related to peripheral vascular atherectomy devices. This guide, intended for both industry and FDA personnel, defines the scope of information to be included in pre-market notifications; in the final 32-page document, these include “descriptive characteristics, labeling, biocompatibility, sterility, non-clinical, animal and clinical performance testing,” according to the Federal Register ad advices.
No public comments were submitted on the draft guideline, and the FDA made no substantive changes from the draft. (RELATED: FDA Draft 510 (k) n Peripheral Atherectomy Device Submission Guidelines, Regulatory Guidance July 26, 2018)
Draft guidelines for blood glucose monitoring devices without insulin
A new orientation project is intended to guide developers of devices intended to therapeutically improve glycemic control in patients with type 2 diabetes (T2DM).
The scope of this guide is intended to include devices such as’ neurostimulators, and those that mimic or cause anatomical changes similar to those brought about by bariatric surgeries, alter the anatomy and / or physiology of the brain. small intestine, or manipulate the sympathetic nervous system. system â€, according to the draft guidance. No such device is currently authorized or approved by the FDA, although the draft document indicates that devices in this area “have become an area of ​​increasing interest.”
Specifically excluded from the scope of this guide are devices for measuring or monitoring blood sugar, those that measure or administer insulin or calculate insulin doses, and software as a medical device (SaMD) to improve glycemic control in patients with T2DM.
The draft guidelines provide specific recommendations for early phase clinical studies of devices to improve glycemic control, including how to select the appropriate study design, length and schedule of follow-up, what sample size is appropriate, and which should be included and excluded from clinical studies. , patient demographics and treatment parameters.
The draft guidelines give specific recommendations on the upper and lower limits of glycated hemoglobin (HbA1c) levels for participants in feasibility studies, and recommends that in addition to their T2DM, patients participating in these studies at a stage early should be “otherwise in good health within the framework of optimal medical management.” . “
Drug management plans for the study of a new device are also described in the draft guidelines. The change in HbA1c is recommended as a key efficacy endpoint for early clinical feasibility and feasibility studies, “because it is a widely recognized objective measure of glycemic control.”
Also discussed are the appropriate safety and efficacy parameters and the data to be collected to support safety and efficacy claims, as well as considerations in the statistical analysis of study data.
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