By Vani Singhal
What should life sciences manufacturers do if contacted by patients?
How much information can the manufacturer pass along, if any?
When responding to a patient inquiry, whether from a telephone call or an email, a medical device manufacturer should frame the communication around the information contained in the device label. A manufacturer should develop and provide detailed and clear instructions on the safe and effective use of every device. The label, or a user guide or instructions for use (IFU), will serve as the manufacturer’s script when responding to patient queries. A manufacturer should not stray from these instructions to advocate an off label use, or give information or advice that could be construed as medical treatment. Device manufacturers should develop a protocol for a “Patient Assistance Line” utilizing the IFU as the guide.
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