US FDA Approved Materials (which can be used for Medical Devices) List?

A

Arnthor

#1
Dear all,

Does US FDA have a database for approved list of materials which can be used for medical device?

When a supplier claim their product is medical grade (eg, Polyethylene), what is US FDA definition of medical grade?

Any insight is appreciated!

Best regards,

Arnthor
 
Elsmar Forum Sponsor
M

MIREGMGR

#2
Re: US FDA Approved material list?

Does US FDA have a database for approved list of materials which can be used for medical device?
Not as such. However, US FDA does Recognize a number of material-related Standards, each of which defines a particular grade, composition or formulation of a material. See http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/default.htm.

If you use such a material in your device, US FDA will accept that material as suitable from a formulation perspective, subject to any special conditions that the Standard defines. You may however have to show that your use of that material is suitable i.e. if the Standard recognizes uses A, B and C but your device uses the material in novel manner D, that will require evidence of suitability. See http://www.fda.gov/MedicalDevices/D...sions/PremarketNotification510k/ucm142706.htm and http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm077274.htm.

When a supplier claim their product is medical grade (eg, Polyethylene), what is US FDA definition of medical grade?
There is no such US FDA definition. Any material can be used in a medical device if it's safe and effective in the application.

Probably what the vendor means is either that the material conforms to a Standard that is Recognized by US FDA, or that the material has been subjected to an appropriate series of ISO 10993 biocompatibility tests by somebody--its maker, the vendor, or someone else--and found to be biocompatible.

In the former case, presumably the material willl be supported with a certification of conformance, plus perhaps some evidence such as a third party lab test. In the latter case, a statement of conformance is meaningless unless a copy of the third party lab test is provided as evidence that you can then provide to US FDA in conjunction with a clearance process for your device.

A warning: if you run into a material vendor that claims medical device suitability based on USP or "Class VI", watch out. FDA split medical device materials qualification from pharmaceutical-packaging materials qualification as of 1995. Anyone still using that system obviously hasn't paid any attention to materials qualification in at least sixteen years.
 
A

Arnthor

#3
Re: US FDA Approved material list?

It is okay to say that if the material pass ISO 10993 biocomp tests, it can be used as a material for medical device?

Is there any extra requirement beside ISO 10993-4 -"Biological evaluation of medical devices -- Part 4: Selection of tests for interactions with blood" testing if I am refering to blood contact component of the device.
 
M

MIREGMGR

#4
Re: US FDA Approved material list?

It is okay to say that if the material pass ISO 10993 biocomp tests, it can be used as a material for medical device?
Biocompatibility of patient contact materials and therefore the resulting device is a necessary, but not a solely sufficient, requirement for a patient contact device.

The fundamental requirement is that, whatever materials are used, the resulting device must be safe and effective.

If a material conforms to a Recognized Consensus Standard and is used in a manner that is consistent with that standard, you don't have to separately prove that that material is suitable.

Other than by conformance to a Recognized Consensus Standard, there is no simple basis for a statement that a material is acceptable for all medical device uses.

Is there any extra requirement beside ISO 10993-4 -"Biological evaluation of medical devices -- Part 4: Selection of tests for interactions with blood" testing if I am refering to blood contact component of the device.
If a device is of a well established type, usually FDA will require only the tests indicated for the intended use in guidance G95-1 http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080735.htm.

If a device presents novel issues regarding biocompatibility, FDA may require additional qualifications.
 
Thread starter Similar threads Forum Replies Date
M ISO 10993 for Fabric based Electrode - Finding already FDA Approved Materials Other Medical Device Related Standards 11
P FDA Approved Product Contact Parts ISO 13485:2016 - Medical Device Quality Management Systems 6
D FDA Approved Class II Medical Device? Other US Medical Device Regulations 11
D FDA filing guidance to add sterilization step for approved drug Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 8
J FDA approved Medical Devices for PVD and DLC Coatings US Food and Drug Administration (FDA) 2
H IVD in US Phase III Clinical Trial - Non-CE Marked and Non-FDA Approved Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 3
S Mexico: Paths to approval for product that is CE-marked, but not FDA approved? Other Medical Device Regulations World-Wide 2
N Has the FDA approved Electron Beam for Sterilization of bottles? US Food and Drug Administration (FDA) 1
Ronen E FDA approved the OraQuick In-Home HIV Test US Food and Drug Administration (FDA) 1
P FDA Approved API (Active Pharmaceutical Listing) Bioequivalence Study Lab for India Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 2
V Advantages of ISO 13485 or 9001 Certification for FDA Approved and Regulated site ISO 13485:2016 - Medical Device Quality Management Systems 3
C Pest Control - FDA approved list of Pesticides to use for Pest Pontrol in a Cleanroom Other Medical Device and Orthopedic Related Topics 10
C Guidance for exhibitors in US - Promote non-FDA approved products to non-US customers US Food and Drug Administration (FDA) 2
Le Chiffre Using the phrase "Approved by FDA" in Marketing and Advertising Material US Food and Drug Administration (FDA) 19
M FDA or USDA Approved Cleaners - Cleaning Agents like Detergents Food Safety - ISO 22000, HACCP (21 CFR 120) 11
C FDA Approved Ultrasonic Equipment - FCC Requirements for US sales US Food and Drug Administration (FDA) 4
J List of FDA approved Manufacturing facilities (India) ?? US Food and Drug Administration (FDA) 6
K Dried Food Packaging - Getting FDA registered / approved US Food and Drug Administration (FDA) 2
S List of Approved Test Laboratories by FDA US Food and Drug Administration (FDA) 5
S Could we get FDA approval just for subsystem - FDA approved medical device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
B Does FDA Registration QSR need to cover non-medical devices for contract repackager? US Food and Drug Administration (FDA) 0
C Non-sterile reusable surgical instruments - FDA sterilization requirement Other Medical Device Related Standards 2
D FDA Information - Revising the Instructions for Use US Food and Drug Administration (FDA) 0
S Transitional Adolescent A and B - "CDRH PREMARKET REVIEW SUBMISSION COVER SHEET FORM FDA 3514" Medical Device and FDA Regulations and Standards News 1
B FDA requirement for CAPA Signoff ISO 13485:2016 - Medical Device Quality Management Systems 6
P MSDS for MVQ FDA White, Vinyl Methyl Silicone Rubber EU Medical Device Regulations 4
S Manufacturing Process FDA FOIA Medical Device and FDA Regulations and Standards News 3
S Manufacturing Process FDA FOIA US Food and Drug Administration (FDA) 4
S Mechanical Test Under FDA Freedom of Information Act Medical Device and FDA Regulations and Standards News 5
A Medical Device Contract Manufacturer - Does the CM need to register with FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
M Supplier requirements - Major supplier is a Non-Profit registered with ICCBBA (FDA UDI) Supply Chain Security Management Systems 12
C RA (Regulatory Assurance) Training (FDA) looking for resources Training - Internal, External, Online and Distance Learning 5
E FDA 513(g) Cover Letter US Food and Drug Administration (FDA) 5
S Records - Do's and don't' of record entries (FDA - 21 CFR 820) Records and Data - Quality, Legal and Other Evidence 13
B New Facility register with FDA Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 4
K 510k FDA review, will they accept Biocompatibility result generated using feasibility product lots? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
J FDA regulation on decorative contact lenses Medical Device and FDA Regulations and Standards News 5
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 3
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
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 7
JoCam FDA Registration for Sub-contract manufacturers Medical Device and FDA Regulations and Standards News 2
M FDA News FDA Releases Draft Guidance Clarifying Application of ISO 10993-1 Biocompatibility Standard Medical Device and FDA Regulations and Standards News 0

Similar threads

Top Bottom