Source: https://elsmar.com/elsmarqualityforum/threads/biocompatibility-testing-multile-products-of-different-sizes-and-shapes.79413/
Timestamp: 2020-08-06 17:08:16
Document Index: 73666275

Matched Legal Cases: ['art 1', 'art 820', 'art 820', 'art 820', 'art 820', 'art 820', 'art 820']

Thread starter khann
We have several products with the same indication that are different sizes and shapes. If the contact material is the same in all of them (material, manufacturer and process) can we do the largest surface area product and cite that data in all of the PMA submissions?
I think you are on the right track. I suggest reading (and applying) "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" Guidance for Industry and Food and Drug Administration Staff". It does include "worst case" language.
https://www.fda.gov/media/85865/download
In addition to what William has said about the "Worst Case" from the context of "Largest Surface Area", I would like to mention about the "Worst Case" from the context of "Difficulty to Sterilize" (guessing your device as a sterile one) while doing the evaluation for the "Representative Device" to conduct the biocompatibility testing and document the decision making process.
K Diagnostic X-ray devices - Applicability of Biocompatibility Testing per ISO 10993-1 Manufacturing and Related Processes 5 Mar 6, 2020
K Biocompatibility Testing - Component Level or Assembled Medical Device? ISO 13485:2016 - Medical Device Quality Management Systems 7 Sep 19, 2017
R What is the expectation for Biocompatibility Testing when switching Suppliers? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 11 Jan 9, 2017
S Biocompatibility testing for nasal prongs made of medical grade silicone 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 9 Jan 14, 2015
J Biocompatibility Evaluation component other than Testing Other Medical Device Regulations World-Wide 1 Sep 18, 2014
J Grouping Products and Testing Sterile and Biocompatibility - Validating Products Other Medical Device Regulations World-Wide 3 Sep 17, 2014
R Is Biocompatibility Testing required for Implantable Class III Devices sent to China China Medical Device Regulations 3 Feb 14, 2014
I Biocompatibility Testing Requirements for a Class I device - Does not contact patient 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6 Mar 16, 2012
C Do we have to use an FDA recognized lab for Biocompatibility testing of 510k devices? Other US Medical Device Regulations 1 Feb 10, 2012
S Biocompatibility - Complement System Testing US Food and Drug Administration (FDA) 1 Apr 3, 2011
W Biocompatibility of Implantable Component - What testing, if any? Other Medical Device and Orthopedic Related Topics 5 Oct 19, 2009
M Medical Device Biocompatibility Testing - End Product or Components - ISO 10993 ISO 13485:2016 - Medical Device Quality Management Systems 22 May 12, 2009
T Animals for biocompatibility testing? Other Medical Device Related Standards 10 Mar 25, 2009
V Biocompatibility testing centre in Montreal QC ? Other Medical Device and Orthopedic Related Topics 3 Dec 2, 2008
A Biocompatibility testing & Registration in China ISO 13485:2016 - Medical Device Quality Management Systems 5 Jun 5, 2008
M Predicate Device - Question on Biocompatibility and IEC 60601-1 Testing Requirements IEC 60601 - Medical Electrical Equipment Safety Standards Series 5 Mar 24, 2008
T Biocompatibility Testing for Implantable Medical Devices according to ISO 10993 ISO 13485:2016 - Medical Device Quality Management Systems 4 Mar 12, 2008
Activation of complement at 90 min - BSI requested for justifications to support the biocompatibility of the device EU Medical Device Regulations 2 Jan 22, 2020
K Biocompatibility classification for Lancet CE Marking (Conformité Européene) / CB Scheme 7 Dec 7, 2018
F Sample Size for Biocompatibility Tests Other Medical Device Related Standards 4 Apr 12, 2018
F Biocompatibility Device Categorization: Priming with Blood Other Medical Device Related Standards 1 Mar 14, 2018
F Biocompatibility on aged devices Other Medical Device Related Standards 3 Jan 16, 2018
Biocompatibility GLP conform tests outside China China Medical Device Regulations 1 Sep 22, 2017
I Biocompatibility Impact on Autoclaved Silicone Other Medical Device Related Standards 3 May 5, 2017
D Should Biocompatibility Tests be performed on Production Samples? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 9 Feb 24, 2017
C Biocompatibility Test for a Non Contact Medical Device US Food and Drug Administration (FDA) 11 Dec 1, 2016
R Biocompatibility - ISO 10993 and SVHC Requirements Other Medical Device Related Standards 4 Jul 22, 2016
Biocompatibility: Blue Book Memorandum #G95-1 superseded by new FDA guidance Other Medical Device Related Standards 1 Jun 16, 2016
S ISO 10993-1: External Communicating Device biocompatibility test requirements Other ISO and International Standards and European Regulations 4 Apr 21, 2015
M Biocompatibility - why are animal studies necessary? Other Medical Device and Orthopedic Related Topics 11 Feb 6, 2015
R Biocompatibility Test of Blue Gown vs Blue Drape 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1 Feb 4, 2015
R FDA Biocompatibility questions for Surgical Gown 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1 Feb 4, 2015
D Biocompatibility requirements for a Class IIa medical device CE Marking (Conformité Européene) / CB Scheme 7 Jan 26, 2015
J Biocompatibility tests in AAA LAC Laboratory ISO 13485:2016 - Medical Device Quality Management Systems 6 Nov 25, 2014
B Biocompatibility for Packaging Materials Other Medical Device Related Standards 3 Sep 30, 2014
S Laminaria - Is a Biocompatibility Study Required? EU Medical Device Regulations 6 Aug 25, 2014
M Biocompatibility in Respiratory Products - Help interpreting whitepaper IEC 60601 - Medical Electrical Equipment Safety Standards Series 22 Aug 18, 2014
S Laminaria - Biocompatibility Study? Imported Legacy Blogs 1 Aug 15, 2014
M Three final products in one biocompatibility test? Other Medical Device and Orthopedic Related Topics 2 Aug 7, 2014
S Selecting materials for implants to comply with ISO 10993 biocompatibility Other Medical Device Related Standards 4 Jul 8, 2014
S Laminaria Stick (Cervical Dilator) - Biocompatibility Test required? ISO 13485:2016 - Medical Device Quality Management Systems 1 Jul 3, 2014
Diagnostic X-ray devices - Applicability of Biocompatibility Testing per ISO 10993-1
Biocompatibility Testing - Component Level or Assembled Medical Device?
What is the expectation for Biocompatibility Testing when switching Suppliers?
Biocompatibility testing for nasal prongs made of medical grade silicone
Grouping Products and Testing Sterile and Biocompatibility - Validating Products
Biocompatibility Testing Requirements for a Class I device - Does not contact patient
Do we have to use an FDA recognized lab for Biocompatibility testing of 510k devices?
Biocompatibility - Complement System Testing
Biocompatibility of Implantable Component - What testing, if any?
Medical Device Biocompatibility Testing - End Product or Components - ISO 10993
Predicate Device - Question on Biocompatibility and IEC 60601-1 Testing Requirements
Biocompatibility Testing for Implantable Medical Devices according to ISO 10993
Activation of complement at 90 min - BSI requested for justifications to support the biocompatibility of the device
Sample Size for Biocompatibility Tests
Biocompatibility Device Categorization: Priming with Blood
Biocompatibility GLP conform tests outside China
Biocompatibility Impact on Autoclaved Silicone
Should Biocompatibility Tests be performed on Production Samples?
Biocompatibility Test for a Non Contact Medical Device
Biocompatibility - ISO 10993 and SVHC Requirements
Biocompatibility: Blue Book Memorandum #G95-1 superseded by new FDA guidance
ISO 10993-1: External Communicating Device biocompatibility test requirements
Biocompatibility - why are animal studies necessary?
Biocompatibility Test of Blue Gown vs Blue Drape
FDA Biocompatibility questions for Surgical Gown
Biocompatibility requirements for a Class IIa medical device
Biocompatibility tests in AAA LAC Laboratory
Biocompatibility for Packaging Materials
Laminaria - Is a Biocompatibility Study Required?
Biocompatibility in Respiratory Products - Help interpreting whitepaper
Three final products in one biocompatibility test?
Selecting materials for implants to comply with ISO 10993 biocompatibility
Laminaria Stick (Cervical Dilator) - Biocompatibility Test required?