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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