Podcast
Questions and Answers
What constitutes a significant change in the manufacturing process of a device?
What constitutes a significant change in the manufacturing process of a device?
Which of the following is NOT considered a part of a significant change regarding a device?
Which of the following is NOT considered a part of a significant change regarding a device?
What is a stock recovery in the context of product management?
What is a stock recovery in the context of product management?
Who is typically responsible for maintaining records related to recalls?
Who is typically responsible for maintaining records related to recalls?
Signup and view all the answers
Which role in the recall process receives updates on potential recall problems?
Which role in the recall process receives updates on potential recall problems?
Signup and view all the answers
What does a recall of a medical device not imply?
What does a recall of a medical device not imply?
Signup and view all the answers
What defines the severity of a recall as Class I?
What defines the severity of a recall as Class I?
Signup and view all the answers
Which of the following is NOT a reason for a medical device recall?
Which of the following is NOT a reason for a medical device recall?
Signup and view all the answers
Who is responsible for taking action in the case of a recall?
Who is responsible for taking action in the case of a recall?
Signup and view all the answers
What is the primary action taken during a recall?
What is the primary action taken during a recall?
Signup and view all the answers
Study Notes
Compass Health SOP: Device Recall and Advisory Notices
- This procedure outlines instructions and a system for assigning responsibilities for recalling distributed Compass Health devices and issuing/implementing advisory notices.
- The scope covers all dispatched, shipped, and distributed Compass Health products, including investigational devices.
- The document specifies recall definitions and procedures for FDA QSR, Health Canada CMDR, and Australian regulations. Specific laws of each country must be followed.
Applicable Standards
- 21 CFR 7 (FDA Voluntary Device Recalls)
- 21 CFR 810 (FDA Mandatory Device Recalls)
- 21 CFR 806 (FDA Corrections and Removals)
Revision History
- Version 1.0, dated January 3, 2024, is the initial release.
Process Roles
- Management Representative of Recall Committee: responsible for maintaining internal records demonstrating efforts to contact all suitable consignees.
- Top Management: receives recall problem updates from Quality Assurance, including recall depth, notice type, and contact methods. They coordinate the recall plan with authorities.
- Recall Committee: responsible for initiating the recall, coordinating activities, and deciding if a recall is necessary. It's composed of minimum CTO, VP of Engineering, and QA/RA manager/director.
- Quality Assurance: responsible for maintaining the procedure and participating in recall initiatives.
Recall Process
- Top Management: ensures the procedure is understood and implemented.
- FDA Recall: refers to correcting or removing a marketed device violating FDA law.
- Health Canada Recall: refers to the manufacturer, importer or distributor's action to correct a faulty device or notify owners about its defectiveness.
- Types of Recalls: Class I (serious risk of death), Class II (temporary or medically reversible adverse health consequences), and Class III (no likely adverse health consequences).
Recall Classification
- Recall Classification (FDA): Class I, Class II, Class III determined by potential risk.
- Recall Classification (Australia/Canada): Follows similar (but not identical) classification structure focusing on potential health risk.
Recall Strategy
- The plan outlines courses of action for recalls to be conducted, addressing issues like depth of recall, public warnings, public notification, and effectiveness checks.
Recall Termination (FDA)
- FDA determines if a recall's termination is to occur, and any action by the sponsor is handled accordingly.
Recall Closure (FDA/Canada/Australia)
- Closure procedures, reporting requirements, disposition details, and required documentation (forms) are outlined.
Record Keeping
- Guidelines for maintaining records (advisory notices, minutes of meetings, correspondence) related to device recalls are provided.
- Records need to be kept for 2 years beyond the product lifecycle.
- Recall and advisory notice forms for FDA, Health Canada, and Australia's TGA are noted.
Contact Information
- Contact information for various individual and regional personnel are included (for the sponsor and FDA/Health Canada/TGA).
Studying That Suits You
Use AI to generate personalized quizzes and flashcards to suit your learning preferences.
Related Documents
Description
This quiz explores the key factors that define significant changes in the manufacturing processes of devices. Test your understanding of what constitutes a major alteration in manufacturing and how it impacts production and quality. Ideal for students and professionals in manufacturing and engineering fields.
