Biocompatibility Test for a Non Contact Medical Device

C

Cybel

#1
Hi there,

we have a 510(k) under review, it is for a non contact infrared thermometer.
The device does not come in contact with the patient, and it is handled by the operator (the part in contact with the hand of the operator is made of raw material which is biocompatible with up to 30 days human contact duration according to USP Class VI and ISO 10993-1).
The contact time of our device, in normal use, is of 5 seconds maximum per measurement. The device is intended for home healthcare, so it is supposed to be use occasionally and in order to take a very limited number of readings.

The FDA reviewer is asking for biocompatibility tests, "since the device does come into contact with the caregiver".
Being a surface device, with contact duration A and intact skin contact, only the basic tests are required, but I think that the reviewer should at least evaluate our risk assessment in order to determine if testing is needed, before ask for tests, as the device can be considered with "transient contact".

Do you have any suggestion?

Thank you very much in advance!
Cybel
 
Elsmar Forum Sponsor

Ronen E

Problem Solver
Staff member
Moderator
#2
Hi there,

we have a 510(k) under review, it is for a non contact infrared thermometer.
The device does not come in contact with the patient, and it is handled by the operator (the part in contact with the hand of the operator is made of raw material which is biocompatible with up to 30 days human contact duration according to USP Class VI and ISO 10993-1).
The contact time of our device, in normal use, is of 5 seconds maximum per measurement. The device is intended for home healthcare, so it is supposed to be use occasionally and in order to take a very limited number of readings.

The FDA reviewer is asking for biocompatibility tests, "since the device does come into contact with the caregiver".
Being a surface device, with contact duration A and intact skin contact, only the basic tests are required, but I think that the reviewer should at least evaluate our risk assessment in order to determine if testing is needed, before ask for tests, as the device can be considered with "transient contact".

Do you have any suggestion?

Thank you very much in advance!
Cybel
Hi Cybel,

Are you aware of this guidance document? It offers some leverage points in your situation, and is supposed to represent the FDA's current thinking on the topic.

Would be interesting to find out how well your FDA examiner knows this document...

Cheers,
Ronen.
 
C

Cybel

#3
Hi Ronen,
thank you for your comment. Yes, I'm aware of the guidance.
I think that also the reviewer is, because this guidance is the only document (from what I know) where biocompatibility is considered also with respect of the operator.
I think also that the guidance is oriented in avoiding biocompatibility tests were not necessary, and that my device falls into that case.

But the reviewer seems to be inflexible.

:-(
 

Ronen E

Problem Solver
Staff member
Moderator
#4
Hi Ronen,
thank you for your comment. Yes, I'm aware of the guidance.
I think that also the reviewer is, because this guidance is the only document (from what I know) where biocompatibility is considered also with respect of the operator.
I think also that the guidance is oriented in avoiding biocompatibility tests were not necessary, and that my device falls into that case.

But the reviewer seems to be inflexible.

:-(
I think that the guidance speaks quite clearly in your favour. You could appeal to that reviewer's superiors, and if that doesn't help you have this option. There should be transparency and accountability in the system.
 
J

Julie O

#5
I think that the reviewer should at least evaluate our risk assessment in order to determine if testing is needed, before ask for tests
This may be a left-hand/right-hand issue at FDA. I think biocompatibility is often a specialized review conducted by a biocompatibility expert, where the risk assessment is reviewed by someone else, probably the lead reviewer.

When you say "the FDA reviewer ," do mean a specific person you have spoken to or have received an email from, or are you referring to an official written communication from the Agency?

You imply, but do not state, that the FDA reviewer you refer to hasn't evaluated your risk assessment. Do you know if that is the case?

Is this a 510(k) or De novo review?
 
C

Cybel

#6
I think that the guidance speaks quite clearly in your favour. You could appeal to that reviewer's superiors, and if that doesn't help you have [ ]. There should be transparency and accountability in the system.
Thank you.
I will consider this possibility.
 
C

Cybel

#7
This may be a left-hand/right-hand issue at FDA. I think biocompatibility is often a specialized review conducted by a biocompatibility expert, where the risk assessment is reviewed by someone else, probably the lead reviewer.

When you say "the FDA reviewer ," do mean a specific person you have spoken to or have received an email from, or are you referring to an official written communication from the Agency?

You imply, but do not state, that the FDA reviewer you refer to hasn't evaluated your risk assessment. Do you know if that is the case?

Is this a 510(k) or De novo review?
Hi Julie, I mean the person who sent us the deficiency letter. The application is a 510(k). I've not submitted a specific risk assessment about biocompatibility, I've only justified in my general Risk Analysis report why biocompatibility tests are not necessary. I guess it is not enough, and obviously I'm completely available in preparing a more detailed document, but he doesn't want it...
 

Ronen E

Problem Solver
Staff member
Moderator
#8
Hi Julie, I mean the person who sent us the deficiency letter. The application is a 510(k). I've not submitted a specific risk assessment about biocompatibility, I've only justified in my general Risk Analysis report why biocompatibility tests are not necessary. I guess it is not enough, and obviously I'm completely available in preparing a more detailed document, but he doesn't want it...
That risk analysis should have been an integral part of the biocompatibility section of your 510(k). One needs to lead the reviewer down the preferred path and not count on them connecting the dots. I hope it's not too late. In theory it shouldn't be, but practice doesn't always align with theory.
 
C

Cybel

#9
That risk analysis should have been an integral part of the biocompatibility section of your 510(k). One needs to lead the reviewer down the preferred path and not count on them connecting the dots. I hope it's not too late. In theory it shouldn't be, but practice doesn't always align with theory.
:( I will learn from this.
You are perfectly right...
Thank you!
 
#10
In Reference to the FDA guidance document posted earlier in the thread - I think the footnote on page 1 just beneath the Introduction may be what the FDA reviewer is using to push back; the key words being their definition of "human body".

"For the purposes of this document, the term “human body” refers to either patient tissues or the clinical practitioner. For example, masks or gloves intended for protective purposes by clinical practitioners should be assessed for biocompatibility. Similarly, medical devices such as implants or skin electrodes also should be assessed for biocompatibility."
 
Last edited:
Thread starter Similar threads Forum Replies Date
S ISO 10993-1: External Communicating Device biocompatibility test requirements Other ISO and International Standards and European Regulations 4
R Biocompatibility Test of Blue Gown vs Blue Drape 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
M Three final products in one biocompatibility test? Other Medical Device and Orthopedic Related Topics 2
S Laminaria Stick (Cervical Dilator) - Biocompatibility Test required? ISO 13485:2016 - Medical Device Quality Management Systems 1
M Biocompatibility Test requirements for 510k - Orthopaedic Implant Screws US Food and Drug Administration (FDA) 2
M Biocompatibility Test Methods for Sensitization US Food and Drug Administration (FDA) 5
J SFDA Biocompatibility Test Report Requests (China) ISO 13485:2016 - Medical Device Quality Management Systems 10
N Can I submit 510(k) without Biocompatibility Test Results? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
bio_subbu Choosing a laboratory for biocompatibility test ISO 13485:2016 - Medical Device Quality Management Systems 8
C Biocompatibility test for absorbable ophthalmic suture EU Medical Device Regulations 1
F Biocompatibility evaluation for Hardware/Interface Components? Other Medical Device Related Standards 1
L Process changes and biocompatibility (ISO 10993-1) Other Medical Device Related Standards 1
Beliz Biocompatibility Testing for Laser Epilation Device EU Medical Device Regulations 2
L FDA Biocompatibility Requirements - Transitory Contact Other US Medical Device Regulations 1
K Biocompatibility Testing - Multile products of different sizes and shapes US Food and Drug Administration (FDA) 2
K Biocompatibility evaluation of gas pathways Medical Device and FDA Regulations and Standards News 5
Kuldeep Singh Diagnostic X-ray devices - Applicability of Biocompatibility Testing per ISO 10993-1 Manufacturing and Related Processes 7
Judy Abbott Activation of complement at 90 min - BSI requested for justifications to support the biocompatibility of the device EU Medical Device Regulations 2
Judy Abbott Can any one help me with an urgent BIOCOMPATIBILITY Impact assessment? Internal Auditing 9
S ISO 10993 Biocompatibility Evaluation - Electronic thermometer Other Medical Device Related Standards 3
shimonv Referring to previously submitted biocompatibility results in a new 510(k) submission Other US Medical Device Regulations 1
I ISO 10993 Biocompatibility Requirements - manufacturing process chemicals Other Medical Device Related Standards 8
R 510(k) Biocompatibility vs Cleaning Validation Other Medical Device Related Standards 4
K Biocompatibility classification for Lancet CE Marking (Conformité Européene) / CB Scheme 7
F Sample Size for Biocompatibility Tests Other Medical Device Related Standards 4
F Biocompatibility Device Categorization: Priming with Blood Other Medical Device Related Standards 1
W Biocompatibility Risk Analysis for Clinical Practitioner 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
F Biocompatibility on aged devices Other Medical Device Related Standards 3
Gamula Biocompatibility GLP conform tests outside China China Medical Device Regulations 1
K Biocompatibility Testing - Component Level or Assembled Medical Device? ISO 13485:2016 - Medical Device Quality Management Systems 7
I Biocompatibility Impact on Autoclaved Silicone Other Medical Device Related Standards 3
D Should Biocompatibility Tests be performed on Production Samples? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 9
R What is the expectation for Biocompatibility Testing when switching Suppliers? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 11
R Biocompatibility - ISO 10993 and SVHC Requirements Other Medical Device Related Standards 4
planB Biocompatibility: Blue Book Memorandum #G95-1 superseded by new FDA guidance Other Medical Device Related Standards 1
M Biocompatibility - why are animal studies necessary? Other Medical Device and Orthopedic Related Topics 11
R FDA Biocompatibility questions for Surgical Gown 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
D Biocompatibility requirements for a Class IIa medical device CE Marking (Conformité Européene) / CB Scheme 7
S Biocompatibility testing for nasal prongs made of medical grade silicone 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 9
J Biocompatibility tests in AAA LAC Laboratory ISO 13485:2016 - Medical Device Quality Management Systems 6
B Biocompatibility for Packaging Materials Other Medical Device Related Standards 3
J Biocompatibility Evaluation component other than Testing Other Medical Device Regulations World-Wide 1
J Grouping Products and Testing Sterile and Biocompatibility - Validating Products Other Medical Device Regulations World-Wide 3
S Laminaria - Is a Biocompatibility Study Required? EU Medical Device Regulations 6
M Biocompatibility in Respiratory Products - Help interpreting whitepaper IEC 60601 - Medical Electrical Equipment Safety Standards Series 22
S Laminaria - Biocompatibility Study? Imported Legacy Blogs 1
S Selecting materials for implants to comply with ISO 10993 biocompatibility Other Medical Device Related Standards 4
T Biocompatibility for "Desktop" used Medical Device ISO 13485:2016 - Medical Device Quality Management Systems 4
A Biocompatibility omission justification for FDA 510(k) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
Ajit Basrur Is Biocompatibility study performed on medical devices for possible contaminants? Other Medical Device Related Standards 4

Similar threads

Top Bottom