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Accessory or Component and the FDA – The Fine Line Between Them

Accessory or Component and the FDA – The Fine Line Between Them

Determining if your product or innovation should be considered a component or an accessory is a critical early-life cycle inflection point. In fact, the distinction between the two terms has long been the subject of debate and interpretation. In August 2017, the FDA began a new effort to classify a “list of [medical device] accessories that the Agency believes are suitable for distinct classification into class I.”  However, this effort lead to even more questions and less understanding between the classification designations and the actual device. Let’s try to break this down to help with the clarification process: What does the FDA consider an accessory versus a component?An accessory is intended to support, supplement, and/or augment the performance of one or more devices, often called “parent devices”. It is considered a finished device—meaning it is ready for use or capable of functioning.A component (in 21CFR 820.3) is defined as “…any raw material, substance, piece, part, software, firmware, labeling or assembly which is intended to be included as part of the finished, packaged and labeled device.” In other words, it would serve no direct medical purpose by itself, in the form that you deliver, and you are not selling directly to patients/end users/health care providers.21CFR 807.65(a) explicitly exempts “a manufacturer of raw materials or components to be used in the manufacture or assembly of a device…”  This means the parts or sub-components that go into make a device are exempt from Registration. The creator of the final device bears the burden of Registration. Let’s talk about some possible scenarios where this designation is important. Company A makes sensors that are incorporated into a finished blood...
FDA Issues New List of 510(k) Exempt Medical Devices

FDA Issues New List of 510(k) Exempt Medical Devices

New Class II 510(k) Exempt Medical Devices As part of the FDA’s movement to decrease regulatory burdens on the medical device industry, the agency published a list of more than 337 Class II product codes of 510(k) exempt medical devices (see the FDA’s Federal Register notice). The FDA has determined that assurance of safety and effectiveness of these devices can be provided by other regulatory controls. By issuing exempt status for these devices, the FDA can redirect resources that would have been spent reviewing these submissions to more significant public health issues. In March of this year, the FDA published a draft of their proposed Class II devices to be exempted in accordance with the 21st Century Cures Act. FDA is now required to publish a list of Class II devices that no longer require premarket notification, also known as 510(k) exempt medical devices, at least once every five years. 93 product codes are now 510(k) exempt subject to partial exemption limitation in addition to general limitations. So, it will be important for manufacturers to confirm if their device is indeed exempt. For example, FDA exempted devices regulated under product code DHB (Radioallergosorbent immunological test system), but they do not believe all products with the product code DHB meet the partial exemption limitation. Therefore, you are still required to file a 510(k) submission if your device falls under product code DHB and is not identified on the list. Pending 510(k) Submissions Medical device manufacturers with pending 510(k) submissions that are now on the list of exempted devices are directed to withdraw their submission. This is great news for these...