1. with Audrey Turley, B.S., RM (NRCM), CBA (ASQ)
How to Develop a Risk Based Biological Safety Evaluation Per New US FDA Guidance
Day 3: Summarize all your findings in a Biological Evaluation Report (BER)
with Audrey Turley, B.S., RM (NRCM), CBA (ASQ)
Research Scientist

2. BIOLOGICAL SAFETY EVALUATION
BEP: What are your risks and how do you plan to mitigate them?
Testing and risk assessments
BER: Is the device safe?

3. WEBINAR SUMMARY DAY 1 – Biological Evaluation Plan (BEP)
Assessing your biocompatibility is not a checklist approach!
Send BEP to regulatory bodies BEFORE you begin.

4. WEBINAR SUMMARY DAY 2 – Understanding Test Options
Know your material, perform useful E&L testing and follow up with a risk assessment.
ISO : Figure 1

5. STANDARDS FOR PRESENTATION
ISO : 2009
“Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process”.
US FDA guidance document
“Use of International Standard ISO , ‘Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process’” issued June 16, 2016.

6. STANDARDS FOR PRESENTATION
Agency advises to start using this now as most submissions will not be complete before the effective date of September 14, The link to the document is here.

7. What is a Biological Evaluation Report?
ANSWER
A BER is a summary of all the evidence gathered to support the biological safety of a device.
Requested in
US FDA guidance document
ISO Clause 7 and Annex B

8. Why do I need a BER? 3) BER If conclusion = “device is safe”, then
1) BEP
2) Testing/risk assessments

9. Why can’t I just submit all my testing reports?
Implant device
Predicate device
E&L testing
Tox Risk Assessment
Cytotoxicity, irritation, sensitization
Particulate testing
Biological Risk Assessment

10. What should a BER contain?
ISO clause 7: “Interpretation of biological evaluation data and overall biological safety assessment” a)
“the strategy and program content for the biological evaluation of the medical device;”
BEP b)
“the criteria for determining the acceptability of the material for the intended purpose, in line with the risk management plan;”
Internal documentation from R&D

11. What should a BER contain?
c) “the adequacy of the material characterization;”
If used to justify out of testing
Well characterized material
Novel material/process

12. What should a BER contain?
d) “the rationale for selection and/or waiving of tests;”
BEP
e) “the interpretation of existing data and results of testing;”
Address any unusual findings

13. What should a BER contain?
f) “the need for any additional data to complete the biological evaluation;”
Extended evaluations, change in standards, etc.
g) “overall biological safety conclusions for the medical device.”
Have all the risks been mitigated?

14. Can I Write a BER myself? Yes
Ensure that all the points in clause 7 are included.
FDA guidance document, Attachment C

15. Summary of 7 points (a-g)
a) Strategy to assess device. What was the BEP?
b) Justification for materials used
c) Was the material characterization adequate?
d) Rationale for selection/waiving of tests
e) Data review and interpretation
f) Was everything covered?
g) Is the device safety well supported?

16. Can I Write the BER myself?
A few things to keep in mind…
ISO states that “Expert assessors..” should review the findings and make an overall conclusion.
Outside perspective
Help with the submission process if it comes back

17. What does Nelson offer in a BER?
BACKGROUND
Reason for testing
Device
Company
a) Strategy to assess device. What was the BEP?

18. What does Nelson offer in a BER?
DEVICE DESCRIPTION
What is it used for
Where in the body is it used
Target population
b) Justification for materials used

19. What does Nelson offer in a BER?
a) Strategy to assess device. What was the BEP?
d) Rationale for selection/waiving of tests
DEVICE CATEGORIZATION
ISO :2009
Device contact
Biological considerations
Duration

20. What does Nelson offer in a BER?
COMPONENTS AND MATERIALS
Material biocompatibility data
COAs
Suppliers
b) Justification for materials used

21. What does Nelson offer in a BER?
TESTING SUMMARY
Tests performed
Laboratory
Standards followed
Study numbers
Results
Abnormal results
c) Was the material characterization adequate?
e) Data review and interpretation
f) Was everything covered?

22. What does Nelson offer in a BER?
c) Was the material characterization adequate?
e) Data review and interpretation
f) Was everything covered?
RISK ASSESSMENT DISCUSSION
Biological Risk
Toxicological Risk

23. What does Nelson offer in a BER?
CONCLUSION
The device is considered biocompatible.
The device is safe for only the following populations…
There are remaining areas of risk that need to be addressed.
g) Is the device safety well supported?

24. What if… …I didn’t have a BEP?
… the testing was done over several years?
…the device has gone through several design changes since the testing?
…we’re putting this all together as an afterthought?

25. Example Projects Catheter family Latex gloves
List all components and justify the use of a representative sample
Latex gloves
Failing cytotoxicity results
Kit with several components purchased at separate facilities
Failing cyto results on one component
New catheter
Predicate device from same manufacturer but shorter in length

26. BIOLOGICAL SAFETY EVALUATION
BEP: What are your risks and how do you plan to mitigate them?
Testing and risk assessments
BER: Is the device safe?

27. Thank you for attending
Questions?
Thank you for attending
How to Develop a Risk Based Biological Safety Evaluation Per New US FDA Guidance