Products that are not sold with a medical function, but that are incidentally used for a medical purpose, are legally general purpose articles and are exempt from all requirements of the Act except for the prohibitions against adulteration and misbranding. Products which are components of or accessories to a medical device are normally regulated in the same way as the "parent" device. For example, if the parent device is subject to GMPs and premarket notification, the normal presumption is for an accessory to be subject to the same requirements, even if marketed separately². Furthermore, the manufacturer of a device is responsible for assuring that the ultimate medical device, including all components, complies with the regulations.

 

Safety and Effectiveness: Dealing with Component Suppliers

The medical device manufacturer is responsible for the safety and effectiveness of all components, including any general-purpose articles incorporated within the device.² 

Whether by 100% component inspection or by approving the component supplier, the ultimate medical device manufacturer is responsible for ensuring that the finished product is safe and effective.

 

Still don’t know Whether your product is a medical device?

Device evaluation and classification activities (Section 513(g)) are carried out by ODE, the Office of Compliance (OC) is bestowed with the responsibility answering inquiries regarding whether or not a particular product is a medical device and thus subject to Center regulatory authority (device determination). If you have doubt as to whether your product is considered a medical device, the best thing to do is to ask the FDA.  You can do so at the following locations:

 

For products regulated by CDRH, requests for classification information under section 513(g) of the act should be submitted to:

513(g) Coordinator,

Food and Drug Administration,

Center for Devices and Radiological Health,

510(k) Document Mail Center (HFZ-401),

9200 Corporate Boulevard, Rockville, MD 20850.

 

For products regulated by CBER, 513(g) requests should be submitted to:

 

CBER Ombudsman,

Center for Biologics Evaluations and Research,

Suite 200 North, HFM-4,

1401 Rockville Pike, Rockville, MD 20852-1448.

 

References:

• Guidance for FDA Reviewers and Industry Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices

 

• Telemedicine Related Activities Center for Devices and Radiological Health Food and Drug Administration 11 July 1996