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cortesejd
I am trying to gain additional insight into a subtle nuance regarding specification developers in order to help a company I am representing. Let’s call them Company A and they are NOT a medical device company, instead they’re in the consumer electronics. Presently Company A is looking to manufacture a consumer electronic product that interacts with human vision.
Background:
Their product does require 20/20 vision to function properly and does not work with prescription eyeware. Corrected vision, contacts or lasik, work fine but glasses are not an option. So as to not eliminate a significant customer base, those wearing eyeglasses, they are thinking of creating a custom frame/lens that will ‘snap’ into the consumer electronic device. The frame/lens will allow for prescription lenses thereby making it a medical device per 21CFR866 (class 1, 510k exempt).
Company A is a consumer electronics company not wanting to get into medical devices. As such, they are looking to arrange for another FDA registered medical device company to manufacture the frame/lens so that they can stay clear of Medical Device regulations.
Question:
I am aware of Class 1 requirements for contract manufacturers and specification developers and appreciate the relationship between the two when jointly manufacturing a medical device. FDA clearly defines Specification Developers as
- Develops specifications for a device that is distributed under the establishment's own name but performs no manufacturing. This includes establishments that, in addition to developing specifications, also arrange for the manufacturing of devices labeled with another establishment’s name by a contract manufacturer.
However, I’ve also found the designation of Specification CONSULTANT yet no clear definition. In your opinion, would it be possible for Company A to help an outside manufacturer (who is FDA registered) to design, manufacture, and distribute the frame/lens to users of the consumer electronic product? And by ‘help’ it would be to purely provide the details for how their lens/frame would need to be designed so that it could fit into the consumer electronics products. Company A would not own, label, or distribute the frame/lens; this would be solely the responsibility of the outside manufacturer.
In this arrangement the goal would be to eliminate Company A’s regulatory requirement to register and create a QMS. Would this arrangement make Company A a specification CONSULTANT and therefore not require registration or GMPs?
Background:
Their product does require 20/20 vision to function properly and does not work with prescription eyeware. Corrected vision, contacts or lasik, work fine but glasses are not an option. So as to not eliminate a significant customer base, those wearing eyeglasses, they are thinking of creating a custom frame/lens that will ‘snap’ into the consumer electronic device. The frame/lens will allow for prescription lenses thereby making it a medical device per 21CFR866 (class 1, 510k exempt).
Company A is a consumer electronics company not wanting to get into medical devices. As such, they are looking to arrange for another FDA registered medical device company to manufacture the frame/lens so that they can stay clear of Medical Device regulations.
Question:
I am aware of Class 1 requirements for contract manufacturers and specification developers and appreciate the relationship between the two when jointly manufacturing a medical device. FDA clearly defines Specification Developers as
- Develops specifications for a device that is distributed under the establishment's own name but performs no manufacturing. This includes establishments that, in addition to developing specifications, also arrange for the manufacturing of devices labeled with another establishment’s name by a contract manufacturer.
However, I’ve also found the designation of Specification CONSULTANT yet no clear definition. In your opinion, would it be possible for Company A to help an outside manufacturer (who is FDA registered) to design, manufacture, and distribute the frame/lens to users of the consumer electronic product? And by ‘help’ it would be to purely provide the details for how their lens/frame would need to be designed so that it could fit into the consumer electronics products. Company A would not own, label, or distribute the frame/lens; this would be solely the responsibility of the outside manufacturer.
In this arrangement the goal would be to eliminate Company A’s regulatory requirement to register and create a QMS. Would this arrangement make Company A a specification CONSULTANT and therefore not require registration or GMPs?