Question

You have just been hired as Director of Regulatory Affairs at a contract sterilizer from a similar position at a surgical instrument manufacturer and are reviewing your firms' records. You haven't come across any device listing forms for the devices your firm sterilizes that are commercially available in the U.S. Which of the following responses is correct?

A) Contact FDA to request a large number of Device Listing forms and assign a member of your staff to begin completing a form for each device your firm sterilizes.
B) Exclude devices from foreign manufacturers from the list being prepared above.
C) Find something else to worry about, contract sterilizers are not required to submit Device Listing forms for the devices they manufacture.

Answer 1

Contract sterilizers are not required to submit Device Listing forms for the devices they manufacture.

Step-by-step explanation:

According to the FDA regulations, contract sterilizers are not required to submit Device Listing forms for the devices they manufacture. Therefore, option C, 'Find something else to worry about, contract sterilizers are not required to submit Device Listing forms for the devices they manufacture,' is the correct response. Contract sterilizers are responsible for sterilizing devices, while the manufacturers of those devices are required to submit the necessary forms.