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Publication Number: 522580 Rule Parts:  Publication Date: 04/12/2007
Keyword: Implanted Medical Devices Labeling

First Category: Administrative Requirements
Second Category: Labelling - Parts 2.925 & 15.19

Question:   What are the labeling requirements for an implanted medical device?

Answer:   The labeling requirements for an implanted medical intentional radiator operating under Part 15 are contained in Section 2.925(e) and Section 15.19 The rules state that where a permanently attached label is not desirable or feasible, such as on an implanted device, then an alternative method may be used, if approved by the Commission. The manufacturer may place the FCC ID on the PC board inside the case (even if it has to be in very small type) and in the instruction manual. The FCC ID is then in the manual and can also be found somewhere on the equipment in case the manual is not available.


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