Thank you for agreeing to participate in this brief survey to assess industry readiness for  implementation of FDA’s Final Rule on Postmarketing Safety Reporting for Combination Products (available here). We hope to use your responses to help advise FDA on reasonable expectations for how long it will take companies to come into compliance with the Final Rule as well as provide insight about potential hurdles, recognizing that FDA guidance on the Final Rule is still forthcoming. All of your responses will be kept anonymous.

* 1. Please indicate what type(s) of combination product(s) your company markets, or plans to market (select all that apply):

* 2. Which category below do the combination products that your company markets, or plans to market, primarily fall into?

* 3. Do you believe your company is on track to implement the postmarket safety reporting requirements laid out in the 2016 final rule, “Postmarketing Safety Reporting for Combination Products” (“Final Rule”) by the compliance date of July 19, 2018?

* 4. Is the planned solution:

* 5. As part of the implementation strategy, have you made any system / IT infrastructure changes?

* 6. At this point in time, how much progress would you estimate that your company has made toward implementation of the Final Rule’s requirements (please provide a percentage, with 100% being fully implemented)?

0% 50%
i We adjusted the number you entered based on the slider’s scale.

* 7. Is your company planning to use the narrative section to report device malfunctions?

* 8. What do you expect the volume of reports to be for combination product device malfunctions that include a device-related reportable event?

* 9. What do you think your company’s top challenges are with respect to implementation of the Final Rule?

* 10. How confident are you that your company’s IT systems will be ready for implementation of the Final Rule?

* 11. As FDA guidance regarding the Final Rule is forthcoming, how long, following release of the guidance, do you think it is reasonable for FDA to expect companies to come into compliance?

* 12. Do you believe postmarket safety reporting for combination products is most effective with a “structured” approach (information placed in structured fields) or “unstructured” approach (information placed in unstructured freeform text/narrative fields)?