SBS - the best value in QMS software

FDA Biocompatibility Requirements - Transitory Contact

#1
Hi,

My company is developing a sensor patch made of biocompatible foam that looks similar to the EKG electrode except that ours is a bit thicker (approximately 0.6 cm), so supposedly when it is attached to the patient's body, the upside will not touch the patient.
We already sent the previous version of the sensor to a third-party laboratory for ISO 10993 testing (<12 hours, intact-skin contact category) and the results indicated no biocompatibility concerns.

Recently, because of clinical feedback, we are looking to print on the upside of the sensor to help the users distinguish the two sides, and to prevent the print from coming off during use, we will add a transparent layer on top.
However, the available biocompatible adhesive is not strong enough to hold the transparent layer in place for multiple uses because the print will affect its adhesiveness. We turn to the adhesive that has not been subject to biocompatibility testing,

My questions are:
1. We think that the non-biocompatible adhesive will be on the upside and is very unlikely to touch the patients under usual use scenario. We think based on ISO 10993-1, the adhesive is categorized as "transitory contact, " and would therefore not requiring biocompatibility testing.
Is this explanation usually acceptable to the FDA? Can different parts of a single device have different contact categories?

Annotation 2020-07-01 111720.png

2. Based on the FDA guidance (Use of International Standard ISO 10993-1), it seems that they are particularly concerned about materials interacting with each other, especially polymers. Would this raise the concerns of the foam polymer interacting with or leached by the adhesive, therefore making the previous explanation not acceptable?
 
Elsmar Forum Sponsor

planB

Trusted Information Resource
#2
lin2020

ad Q1:
you may want to take a decision for the adhesive, based on your product design: either it is not in potential patient contact when your device is applied according to its intended use - then ISO 10993-1 does not apply; or the adhesive is in potential body contact when the device is used as intended.

For the latter case, your final device has to be biocompatible. The exposure duration "transitory" still requires you to perform a risk-based biocompatibility evaluation for the device also considering the adhesive. You may waive dedicated biocompatibility testing (and only rely on existing data) to support this evaluation - with a caveat, quote from ISO 10993-1:2018, section 5.3.2:

However, for products made with materials such as coatings or lubricants that could be left in contact with body tissues after the medical device is removed, it is possible that a more detailed biocompatibility assessment will be necessary. Cumulative use should also be considered.
So if you claim potential body fo the adhesive, FDA might challenge you in case your biocompatibility evaluation does not consider the adhesive as part of your final device.

> Can different parts of a single device have different contact categories?

Yes, they can - quote from ISO 10993-1:2018, section 5.1:

Certain medical devices might fall into more than one body contact or duration category, in which case evaluation appropriate to each category shall be carried out.
ad Q2:
You may want to gather adequate physical and chemical composition information to reach an informed decision for your desired combination of materials (over their lifecycle). If existing data does not allow you to perform this assessment, then further experimental characterization (e.g. chemical analysis of extracts and even biological testing in a second step) may be necessary.

HTH,
 
Thread starter Similar threads Forum Replies Date
M FDA News FDA Releases Draft Guidance Clarifying Application of ISO 10993-1 Biocompatibility Standard Medical Device and FDA Regulations and Standards News 0
planB Biocompatibility: Blue Book Memorandum #G95-1 superseded by new FDA guidance Other Medical Device Related Standards 1
R FDA Biocompatibility questions for Surgical Gown 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
A Biocompatibility omission justification for FDA 510(k) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
C Do we have to use an FDA recognized lab for Biocompatibility testing of 510k devices? Other US Medical Device Regulations 1
J FDA regulation on decorative contact lenses Medical Device and FDA Regulations and Standards News 4
P Anyone have an Idea on UAE Medical device registeration- Class B with FDA only Other Medical Device Regulations World-Wide 0
F FDA classification for a mobile app Medical Information Technology, Medical Software and Health Informatics 2
Ed Panek IFU Contact Requirements - FDA and MDD/MDR US Food and Drug Administration (FDA) 1
O Any info on release date of FDA “Computer Software Assurance for Manufacturing and Quality System Software” document? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
P Writing a presubmission to the FDA prior to the De novo submission US Food and Drug Administration (FDA) 4
K FDA - Can we have more than 1 Initial Importer Medical Device and FDA Regulations and Standards News 4
K Two FDA questions regarding UDI (and potentially 803.52 MDR) Other US Medical Device Regulations 0
R Importers - For the FDA Registration/ Listing, is the CMO the importer? Medical Device and FDA Regulations and Standards News 6
Z Iterative development and FDA change requests IEC 62304 - Medical Device Software Life Cycle Processes 12
P FDA Approved Product Contact Parts ISO 13485:2016 - Medical Device Quality Management Systems 6
O Clarifying FDA definition of "finished device" and “capable of functioning” 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
A FDA guidance on non-sterile Medical Device Packaging Medical Device and FDA Regulations and Standards News 6
JoCam FDA Registration for Sub-contract manufacturers Medical Device and FDA Regulations and Standards News 2
M Is IEC 60601-1-2 required by FDA for all electronic medical devices? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
E Contract manufacturer FDA requirements foreign company US Food and Drug Administration (FDA) 6
P Choice of FDA reviewer US Food and Drug Administration (FDA) 6
J Is Device Tracking Card an actual requirement under FDA regulation? Other US Medical Device Regulations 0
T Definition Human Use (FDA) Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 7
K FDA 510k electrosurgery 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
J Leveraging FDA 510k Clearance for International Registrations Other Medical Device Regulations World-Wide 2
shimonv FDA News FDA guidance on Multiple Function Device Products (8/2020) Other US Medical Device Regulations 1
N FDA UDI - Label vs. Labeling - Does the insert need to include UDI? Other US Medical Device Regulations 1
J FDA notification of address change US Food and Drug Administration (FDA) 2
N Usability testing required for FDA IDE (investigational device exemption)? Human Factors and Ergonomics in Engineering 3
A FDA Class Classification for a cabinet 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
Edward Reesor FDA DM and /or Class I Life Saving US Food and Drug Administration (FDA) 0
Watchcat FDA will not tolerate fraud…meaning what, exactly? Other US Medical Device Regulations 6
K FDA Premarket Cybersecurity Guidance - 4 questions Other US Medical Device Regulations 5
gunnyshore Form FDA 3500A MedWatch eSubmitter 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
Watchcat FDA Webinar Series - N95 Respirators Other US Medical Device Regulations 0
M Off-Label Use - Clarification of FDA Policy US Food and Drug Administration (FDA) 1
J Sub-supplier change from manual to automated process - same specs - Report to FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
C FDA Establishment registration - Buying some medical devices from another manufacturer Medical Device and FDA Regulations and Standards News 5
I How to classify a medical device based on FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
dinaroxentool Question about FDA Classification of a Device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
S The US FDA requirements on Disposal of a medical device US Food and Drug Administration (FDA) 1
S FDA Requirements for Medical Device Label Reconciliation 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
S What is considered a "core algorithm"? (From an FDA guidance document) Medical Information Technology, Medical Software and Health Informatics 4
B FDA-Medical Device Reporting (MDR )procedure compliant with 21CFR section 803 US Food and Drug Administration (FDA) 0
Stoic Are any medical device companies using the 2011 FDA process validation guidance instead of GHTF/SG3/N99-10:2004? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
D ISO 13485, FDA 21 CFR 820 and Auditing the Accounting Department ISO 13485:2016 - Medical Device Quality Management Systems 5
S FDA's E submitter - For clinical electronic thermometer Medical Device and FDA Regulations and Standards News 6
J FDA wants electrical safety testing on battery powered medical device US Food and Drug Administration (FDA) 11
A FDA and NB audit of Engineering Drawings in DHF and DMR. Medical Device and FDA Regulations and Standards News 1

Similar threads

Top Bottom