A medical device manufacturer is preparing a report for their Class II Recall to submit to the FDA. The manufacturer ha
Posted: Mon Apr 04, 2022 6:38 am
A medical device manufacturer is preparing a report for their
Class II Recall to submit to the FDA. The manufacturer has
completed full reconciliation assessments of the recall in terms of
best and strategic approach for recall strategy implementation. The
information described in the recall report does not add any "risk
to health". What should be the next step for the manufacturer?
Group of answer choices
A. Submit the recall report within 10-days
B. No report is required to be submitted
C. Submit the report within 15-days.
Class II Recall to submit to the FDA. The manufacturer has
completed full reconciliation assessments of the recall in terms of
best and strategic approach for recall strategy implementation. The
information described in the recall report does not add any "risk
to health". What should be the next step for the manufacturer?
Group of answer choices
A. Submit the recall report within 10-days
B. No report is required to be submitted
C. Submit the report within 15-days.