The Food and Drug Administration (FDA) has developed a document to describe relevant information that should be provided in a premarket submission which covers such subjects as premarket approval (PMA) applications, humanitarian device exemption (HDE) applications, premarket notification submissions, investigational device exemption (IDE) applications to support a claim of electromagnetic compatibility (EMC) for an electrically-powered medical device. Electrically-powered devices include alternating current (AC) main powered devices, battery powered devices, and active implantable devices. The draft of this document was issued on November 2, 2015. The final document was issued on July 11, 2016.
EMC is described as a device’s ability to perform safely and effectively without giving off excessive electromagnetic emissions that might interfere with other electromagnetic devices, or being affected by other electromagnetic interferences.
In normal circumstances, the review of EMC information in a submission is assessed and based on the risk associated with EMC malfunction or degradation of the device under review, as well as the use of appropriate FDA-recognized standards or appropriate consensus standards. Medical device manufacturers have to abide by these FDA-recognized standards in premarket submissions to get their devices approved.
This is not the first time that FDA issued guidelines for approving medical devices. On 10th May, FDA issued Guidelines For 3D Printed Medical Devices. The proposal was aimed to streamline the complete 3D manufacturing process. The guidelines were meant to provide manufacturers an insight into the thought process of the agency when the idea is conceptualized. These regulations will provide the technical aspects that need to be considered during the initial stages of 3D manufacturing process in order to comply with the agency’s rules and regulations.
It is to be noted however that FDA’s guideline documents do not establish or enforce legal rules or regulations. Instead they are merely recommendations and describe the agency’s viewpoint on a topic. They are recommendations and suggestions, not requirements.
The rules that FDA introduced to facilitate EMC analysis in premarket approval are:
- The context need to be defined by the manufacturer for which the medical device is intended to be used;
- a summary of the testing process that was performed to support EMC needs to be provided;
- the detailed specifications of the standards that were met by the device (including immunity test levels);
- a summary of the device-specific pass/fail criteria used needs to be mentioned, including how the pass/fail criteria were derived. Each medical device should have specific criteria based on the device’s functionality, indications, intended use, and performance. Any specific device standards may contain device-specific test methods and pass/fail criteria that can also be referenced;
- the specific functions of the device that were tested should include performance that was performed and how these functions were monitored during testing. For example, use quantitative measurements and visual observation to monitor the specific functions of the medical devices. The monitoring system should not affect the test;
- specific information about the performance of the device during each test, demonstrating that the device met the emissions and immunity pass/fail criteria. This includes a summary of any device effects, disruptions, or degradations observed during testing and how these were reduced;
- an identification of and a justification for any of the standard’s allowances that were used, if applicable;
- a description of and justification for any changes from the specifications of the referenced standard should be provided. The justification should explain how the deviations would not compromise the safety and performance of the device;
- the device labeling and evidence of compliance with the reference standard’s labeling that include identification, marking and documents specifications;
- a detailed description of all changes or modifications that were made to the tested version of the device in order to pass any of the EMC tests. If modifications were made, a statement should be included in the premarket submission indicating that the changes or modifications will be incorporated into the legally marketed version of the device prior to marketing and documented in the design history file in accordance with design controls. Additionally, manufacturers should assess whether these modifications might impact other aspects of the device performance, for example, compatibility with other devices, and provide information in the device description section of the submission to demonstrate that the modifications would have no impact on other features of the device or that the modified device was used for the other performance tests.
These guidelines will provide device manufacturers and industry leaders a good guiding map to properly assess their device’s performance, effectiveness and compatibility with accordance to FDA standards. Such policies will not only benefit device manufacturers, by cutting down redundancies, production costs and time, they will also benefit both patients and doctors as it will instill a sense of ease in them, once they realize that the devices they are using have passed proper testing phases.