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FDA Time Frames (Device) RAC Exam 2024 | 35 Questions with 100% Correct Answers | Verified | Latest Update 2024| Graded A+ $12.49   Add to cart

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FDA Time Frames (Device) RAC Exam 2024 | 35 Questions with 100% Correct Answers | Verified | Latest Update 2024| Graded A+

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FDA Time Frames (Device) RAC Exam 2024 | 35 Questions with 100% Correct Answers | Verified | Latest Update 2024| Graded A+

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  • October 26, 2024
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FDA Time Frames (Device) RAC Exam
2024 | 35 Questions with 100% Correct
Answers | Verified | Latest Update 2024|
Graded A+


MDR - Death, serious injury or malfunction reports only (Important) -

✔✔30 calendar days (On Form 3500A) + 30 WORKING days for follow-up

report




Devices - Baseline report (Important) - ✔✔Updated as new model added +

annual if model changed. (On Form 3417)

NO annual reporting for manufacturer (unlike drugs)


Distributors - NO reporting




User reporting - Devices: Deaths to Manufacturer & FDA (Important)


User reporting - Devices: Serious injury to Manufacturer (or FDA if M/F unknown)

- ✔✔10 WORKING days (On Form 3500A)

, User reporting - Devices - Total deaths & serious injuries to FDA (Important) -

✔✔Annual




User reporting - Devices - Malfunction (Important) - ✔✔Voluntary




Manufacturing Records (Record Retention) - Devices - ✔✔Expected life of

the device, (NEVER less than 2 years from the date of distribution)




Complaints - Devices - ✔✔Expected life of the device, (NEVER less than 2

years from the date of distribution)




MDR Records - Devices - ✔✔Expected life of the device, (NEVER less than 2

years from the date of event)




Recall - Devices, Drugs or Biologics - Firm Initiated - Report to FDA (Important) -

✔✔10 days

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