Understanding the FDA’s Device Accessory Guidance
And How the FDA’s Rule on Medical Device Accessories Impacts Your MedTech Company’s Submission Strategy
Device Accessory Guidance
The healthcare industry is constantly evolving, driven by technological advancements that have revolutionized patient care. Medical device accessories play a vital role in this evolution, enhancing the functionality and capabilities of existing devices. To ensure the safety and effectiveness of these accessories, the U.S. Food and Drug Administration (FDA) has developed a comprehensive framework known as the Device Accessory Guidance.
Before delving into the FDA's guidance, it's essential to understand what medical device accessories are.
Definition: An accessory is a finished device that is intended to support, supplement, and/or augment the performance of one or more parent devices.Medical device accessories encompass a wide range of products, from smartphone apps that facilitate remote monitoring to adapters and connectors for diagnostic equipment. They can be integral to the functioning of the parent device, and, as such, their regulatory classification is crucial to patient safety.
Accessory Requests
Accessory requests are formal submissions made to the FDA for the classification and regulation of a medical device accessory. These may be submitted for a new or existing accessory type. More explicitly defined:
A new accessory type is an accessory which has not been previously classified under the FD&C Act, cleared under a 510(k), or approved in a PMA. A New Accessory Classification Request is a request included in a PMA or 510(k) submission for proper classification of a new accessory type.
An existing accessory type has already been granted marketing authorization for another device with which it is intended to be used, but an existing accessory request may be submitted to classify this for another device.
Timeline
FDA may grant or deny an Accessory Classification Request.
Accessory Application Sections (Select Examples)
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Identification of the accessory for which a different classification from the parent device is being requested;
Identification of the proposed classification of the accessory (i.e., class I or class II)
The necessary information, based on Least Burdensome principles, to establish the risk profile of the accessory when used as intended with the parent device.
Requests for classification of an accessory into class II must include an initial draft proposal for special controls, if special controls would be required pursuant to subsection 513(a)(1)(B) of the FD&C Act.
Conclusion
In the ever-evolving landscape of healthcare technology, the FDA's Device Accessory Guidance provides a well-structured framework that benefits both manufacturers and patients. By offering a systematic approach to classifying and regulating medical device accessories, the FDA strikes the right balance between promoting technological advancement and safeguarding public health. This guidance not only benefits the healthcare industry but, most importantly, ensures that patients receive the best care with minimal risk. As technology continues to evolve, the FDA's guidance will remain crucial in shaping the future of medical device innovation and patient safety.
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