The document discusses regulatory gray areas and provides examples of how experts navigate ambiguous requirements. It addresses topics like complaints, clinical evaluation reports, unique device identification, and validation sample sizes. For complaints, it provides case examples and discusses when to investigate and report. For clinical evaluation reports, it discusses author credentials and responding when not all indications have data. For unique device identification, it discusses applicability based on size. For validation, it discusses sample size requirements and working with suppliers. Finally, it discusses supplier relationships and appropriate handling of defects. The key takeaway is that communication, documentation, and asking for help can aid in navigating regulatory uncertainties.
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Regulatory and Quality Affairs: Answers to FDA and ISO Gray Areas
1.
2. 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
3. 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
4. What is the Gray Area?
Example of Design Input – Implant Must Be Blue
5. 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
6. 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
7. 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?
8. 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?
9. Markings (UDI)
Does US UDI apply?
What’s actually marked on the device?
Non-sterile reusable drill guide
10. 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
11. 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?
12. Supplier Relationship
Background
• Supplier inspection identifies a
visual defect in the secondary
sterile barrier
• Inspection of sealer identifies
deformation of the seal element
13. 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?
15. 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.
16. 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.
17. 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.
