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Regulatory and Quality Affairs: Answers to FDA and ISO Gray Areas

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Every day, people like you in companies everywhere are sidetracked from more pressing priorities by questions and scenarios that aren’t clearly explained in a regulation or standard (a.k.a. "gray areas"). This panel of regulatory and quality experts were charged with mitigating your roadblocks and getting you on your way. Our panel shared their perspective on the pressing questions received from a pre-conference attendee questionnaire, including UDI and supplier relationships.

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Regulatory and Quality Affairs: Answers to FDA and ISO Gray Areas

  1. 1. Regulatory and Quality Affairs: Answers to FDA and ISO Gray Areas Jeff Tyber, Chief Executive Officer, Tyber Medical Dawn Norman, Executive Vice President, MRC-X Kimberly Light, Director of Regulatory, BioPro Ryan Belaney, Sr. Director, Regulatory Affairs, Active Implants
  2. 2. Objective of this Session • Situational interpretation from the experts • Examples of how to navigate new, ambiguous, unknown, or constantly changing requirements for compliance. • OMTEC audience identified the following topics: • Complaints • Clinical Evaluation Report • UDI • Sample Size/Statistical Justification • Supplier Relationships
  3. 3. What is the Gray Area? Example of Design Input – Implant Must Be Blue
  4. 4. Complaint? Background • 23 year athletic male • Distal screw was tightened via freehand fluoro visualization • “Screw appeared to be jammed and not tightening” • Driver tip confirmed fractured intraoperatively and removed. • Additional driver used and completed procedure Complaint? Investigate? Reportable? Case Example from G.S. Dharmshaktu , Prog Orthop Sci 2016, 2(3), pg 20-22
  5. 5. Complaint? Background • Fibular fracture with ankle instability • Syndesmotic screw placed to stabilize ligament instability • 6 weeks post op patient complains of Pain • Syndesmotic screw fractured (common implant fracture) • Required reoperation Complaint? Investigate? Reportable? Riedel et. al., Injury, 49 (4), Apr 2018, 877-880
  6. 6. Clinical Evaluation Report (CER) Product Details: • 3+ years on the US market • Made from Ti-6Al-4V • Indicated for fusion, arthrodesis, and fracture fixation • What credentials does the author need? • How to respond to “Not all the indications have clinical data with equivalent devices.” • What action can be taken when the clinical evidence doesn’t identify the device?
  7. 7. Unique Device Identification (UDI) Background: • Non-sterile drill and guidewire • Main diameter is <2.0mm • Drill lasermarked with Does US UDI apply? How does size play into your decision?
  8. 8. Markings (UDI) Does US UDI apply? What’s actually marked on the device? Non-sterile reusable drill guide
  9. 9. Validation Sample Size/Statistics Background: • Low risk instrument • Suppliers molding process is to be validated • Sampling plan to assure 99% confidence with 99% reliability • Supply partner wants to run parameters over a minimum of (2) OQ runs and (3) PQ runs
  10. 10. Validation Sample Size/Statistics Background: • OQ/PQ validation will require a minimum of 2295 components • Total order for these devices is 600 pieces. Should the process be validated? Are the confidence and reliability levels appropriate? How can you work with your supplier?
  11. 11. Supplier Relationship Background • Supplier inspection identifies a visual defect in the secondary sterile barrier • Inspection of sealer identifies deformation of the seal element
  12. 12. Supplier Relationship Background • Supplier inspection identifies a visual defect in the secondary sterile barrier • Inspection of sealer identifies deformation of the seal element • Dye penetrant confirmed seal intact How should the supplier handle this? What notifications should be given to the customer? What should the customer do?
  13. 13. Open Forum Scenarios From the Audience
  14. 14. CE Marking Markings Class I (MDR) ARTICLE 52 (7) - CONFORMITY ASSESSMENT PROCEDURES Manufacturers of class I devices, shall declare the conformity by issuing the EU declaration of conformity after drawing up the technical documentation. If those devices are placed on the market in sterile condition, have a measuring function or are reusable surgical instruments, the manufacturer shall apply the procedures set out by the notified body. XXXX VS.
  15. 15. CE Marking Markings Class I (MDR) “Reusable surgical instrument” means an instrument intended for surgical use in cutting, drilling, sawing, scratching, scraping, clamping, retracting, clipping or similar procedures, without a connection to an active device and which is intended by the manufacturer to be reused after appropriate procedures such as cleaning, disinfection and sterilization have been carried out. XXXX VS.
  16. 16. CE Marking Markings Class I (MDR) ARTICLE 20 - CE MARKING OF CONFORMITY 4. The CE marking shall be followed by the identification number of the notified body responsible for the conformity assessment procedures set out in Article 52…. XXXX VS.
  17. 17. CE Marking Markings Class I Instrument XXXX VS.
  18. 18. CE Marking Markings Class I Tray XXXX VS.
  19. 19. Key Take Away 1. Communication is a two-way street 2. Document logic process and justifications 3. It’s okay to ask for help (FDA/NB/Network)
  20. 20. Thank You!!!!

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