a.) if the above statement is true
Premarket approvals and notifications for the medical devices in USA, including Puerto Rico are under the FDA jurisdiction, so the answer is yes.
there is a specific FDA regulation regarding labeling of the devices sold in Puerto Rico:
21 CFR 801.15(c)
33 says that a device is misbranded under section 502(c) of the Act unless:
“All words, statements, and other information required by or under authority of the act to appear on the label or labeling shall appear thereon in the English language: Provided, however,
That in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English, the predominant language may be substituted for English.”