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What information can I use to advertise for my unapproved PMA medical device when recruiting investigators?

Your advertising should be limited to:

Manufacturer’s name and address

Information on how the investigator can apply

How an investigator can go about obtaining the investigational device

What the investigator’s responsibilities are

And a description of the investigational device and proposed study

Do not make claims on the product’s safety and efficacy

Do not include device’s pricing information

Do not make comparative descriptions to other devices including devices you already have on the market

Do not enroll excessive patients or investigators

Do not offer discounts on bulk purchases

Do not seek additional sponsors