Franklin Delano Roosevelt, more affectionately known as FDR, is the longest serving president in U.S. history. Throughout FDR’s nearly four terms in office, he suffered from paralysis that has been attributed to polio. Although the source of his immobility has been questioned recently, it is not debatable that polio was the cause of several epidemics during the nineteenth and twentieth centuries. However, the development of an effective vaccine and the widespread inoculation of the public resulted in the eradication of this malady in 1979. This is a great achievement, yet it can only be sustained by the continued commitment to preemptive protection.
This same strategy drives the regulatory requirements of the Federal Drug Administration (FDA) that all medical devices be registered and classified based upon the potential for harm with their usage. Based upon this classification, which can be 1, 2, or 3, additional precautions may need to be taken by suppliers of medical devices. The most rigid of these are reserved for class 3 medical devices, which pose the greatest risk to patients and users. Let’s first take a look at how to determine if your medical device is class 3, and if so, what guidelines you should follow for the development of its PCB(s).
Is Your Medical Device Class 3?
The first thing you need to do before developing a medical device is register with the FDA. This registration must be done annually for any entity, foreign or domestic, that produces, distributes, imports, or exports a medical device. In addition to registering, there may be other activities that must be performed to adhere to the FDA’s regulation of medical products that are made commercially available in the U.S. In order to determine which of these apply to your medical device, you must determine its classification.
How to Determine Your Medical Device Classification
Class 3 medical devices must meet the general and special requirements mandated for class 1 and class 2 medical devices; which should include design for safety, building for quality and testing for reliability. There are basically two ways to determine whether or not you have a class 3 medical device. Both methods can be executed by utilizing information available from the FDA online. Either method may be used for classifying a product type that is currently on the market; however, for new products, the second method below is probably the better option.
Method A: General Search
This is the simplest and most direct way to locate an existing device and its classification level. From the medical devices database, simply enter a part or all of the product name. This will generate a list of all devices related to the search term. Each entry will include a product code, link to the device’s description, and its classification. An example is shown below.
From this list, find the entry that most closely matches your device. More detailed information can be accessed by clicking on the product link.
Method B: Panel Match
The classification for a known product can also be found by first going to the panel listing of medical devices. Next, select the regulation citation for the panel under which you expect your device to be categorized. This will provide you with all medical devices that fall under that panel, arranged in subcategories, as shown below.
From here, click on the device link to access the detailed information page.
If your device is found to be class 3, then it will require premarket approval (PMA), unless it is a pre-amendments device or was on the market prior to May 28, 1976.
Developing Your Class 3 Medical Device PCB
If you have a post-amendments class 3 medical device (which was not commercially available before the Medical Device Amendments of 1976 went into effect), it will be necessary to obtain PMA before your device can be marketed and sold. Furthermore, based on Section 510(k) of FDA requirements for medical devices, in order to introduce a new medical device into the U.S. market from a domestic or foreign supplier or significantly change the labeling or packaging of an existing device, premarket notification at least 90 days in advance of introduction is required. Obtaining the PMA is a far more stringent review process and includes the following major steps:
Step #1: Acceptance and filing reviews
This step is to ensure that proper and complete documentation is filed such that the review process can be performed. This review is limited in scope and is performed by FDA staff personnel.
Step #2: Substantive review
During this step, in-depth analysis and evaluation of the device and adherence to regulatory and quality requirements is performed by suitable FDA personnel.
Step #3: Panel review
Here, an FDA advisory panel comprised of personnel able to understand and evaluate the medical device for safety and effectiveness perform a review and make recommendations.
Step #4: Notification
Once the review is completed, the applicant is notified of the FDA decision, which may be approval, non-approval, or either of these with information requests or suggestions.
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Obtaining PMA is an essential step in the development of any class 3 medical device and its electronic and PCB contents. As this process includes a review of the quality management and the ability of the device to perform effectively, it is imperative that all applicable regulations and standards for medical devices be followed.
At Tempo Automation, we are committed to working with you to build the highest quality boards at the highest level of efficiency. And to help you get started on the best path, we furnish information for your DFM checks and enable you to easily view and download DRC files. If you’re an Altium user, you can simply add these files to your PCB design software.