Recall Simulation - CBI | Powering Thought Leadership ... · IVT December 2016 Recall Simulation ... • Specific form / format for closure request • May require completion in justification
This document is posted to help you gain knowledge. Please leave a comment to let me know what you think about it! Share it to your friends and learn new things together.
• Notification to authority within the prescribed timelines (FDA Part 806, HC Section 64, Field Safety Corrective Action Report (FSCA), etc.)
Note: Reason for action may dictate if formal notification is required
• Will require: Affected product list Consignee List Reason and justification (likely the associated HHE/HRA) Draft of consignee notification High level strategy including effectiveness check
• Local language translations of FSN, if applicable
• Periodic Updates and request for closure• Specific form / format for closure request• May require completion in justification or globally
File and gain agreement on FSCA with lead authority
• Note: if the action originated within the jurisdiction of a CA other than your lead authority, then notification of the FSCA to the lead authority and the other affected CA shall be conducted in parallel
Additional Competent Authorities (CA)
• File the agreed FSCA with each of the affected authorities
• Report the number of affected units and the affected consignees in that country
Lead Competent Authority will issue National Competent Authority Report (NCAR)
• The FSCA will serve as an input to NCAR
Action for each country can commence when the CA for that country has been notified
Send status reports on a pre-defined basis
Submit a closing status report to each CA including:
• Rate of completion of the action for the Authority’s local jurisdiction and
• Relevant justification for any part of the action that is incomplete
Clearly identify the product (affected batch, model, lot, serial number(s) etc.) and any other pertinent descriptive information to enable accurate and immediate identification of the product
Explain concisely the reason for the field action and the hazard involved, if any Provide specific instructions on what, if anything, should be done with respect to the
affected product or any other action the recipient needs to take Where appropriate, that further distribution or use of any remaining product should
cease immediately Instruction to distribute the notification to the applicable personal Contact information
Separate notification may be appropriate for Distributors • Notify its affected customers about the field action OR notify Manufacturer who
their affected customers are
Should not contain irrelevant qualifications, promotional materials, or any other statement that may detract from the message.
Note: Follow authority guidelinesE.g., 10.5 ANNEX 5 - Template for a Field Safety Notice MEDDEV 2.12-1 rev 8
• Avoid contradicting what was previously communicated with authorities• Have you captured ALL affected product – define what is in-scope and what is not
(HRA/HHE should define this)• Have you captured ALL affected consignees – Accurate sales records
• Response Form: Ensure you capture all relevant data from your consignee (where applicable)• Certificate of Destruction• Quantities in stock• Software upgrade installed• Confirmation that Distributor has notified their end users• Confirmation that FSN has been circulated to relevant departments within organization
• Distributors:• What agreement is in place (Contractual agreements for Recall Activity)• Tracking communications received from indirect customers (i.e., distributor end-users