FDA approved Medical Devices for PVD and DLC Coatings

J

Jelen

#1
#1
Hello,

Not sure if this is the relevant place to ask - I am trying to find a list of medical devices and instruments that have been FDA approved for PVD and DLC coatings.

Does anyone know where I can find such list?

Thanks!

Jelena
 
GAGEpack - Gage & Calibration Management
Elsmar Forum Sponsor
P

pkost

Trusted Information Resource
#2
#2
I'm not aware of any specific list beyond looking at individual devices that you know to use PVD or DLC and then checking the FDA database

When you say PVD or DLC do you mean DLC's that have been applied by a PVD method? what about DLCs via CVD? The majority of MD's that I'm aware of use a CVD technique

Obvious places to start would be:
- heart valves - St Jude Medical
- orthopedic replacement joints - Integra

For orthopaedics I would focus on extremities; there have previously been a couple of DLC coated hip joints but they were academic in nature and not really commercialised, I don't think they were in the US/FDA either


It may be worth asking a moderator to move this into a new thread as it will gain more relevent attention instead of being buried in a thread about adhesives!
 
J

Jelen

#3
#3
Thanks for the reply!
Yes it seems that I have a lot of leg work in-front of me, was hopping there would just be a list of approved coatings (FDA).

Best,
Jelena
 
Last edited by a moderator:
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
D FDA Approved Class II Medical Device? Other US Medical Device Regulations 11
A US FDA Approved Materials (which can be used for Medical Devices) List? Other US Medical Device Regulations 3
S Could we get FDA approval just for subsystem - FDA approved medical device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
P FDA Approved Product Contact Parts ISO 13485:2016 - Medical Device Quality Management Systems 6
D FDA filing guidance to add sterilization step for approved drug Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 8
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
M ISO 10993 for Fabric based Electrode - Finding already FDA Approved Materials Other Medical Device Related Standards 11
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
M FDA Medical device reporting (Manufacturer in US; contract manufacturer OuS) US Food and Drug Administration (FDA) 0
JesseE Electronic signatures FDA CFR 820 ISO 13485:2016 - Medical Device Quality Management Systems 3
C FDA logo for marketing US Food and Drug Administration (FDA) 3
G FDA clearance for a device that can't be used clinically (at present) Other US Medical Device Regulations 5
M FDA Syringe Marking requirements US Food and Drug Administration (FDA) 4
K Guidance on X-Ray Medical Devices for Animal Use - FDA US Food and Drug Administration (FDA) 0
S FDA 510(K) submission question US Food and Drug Administration (FDA) 4
T FDA UDI Question - Class II Medical Device Other US Medical Device Regulations 2
P Does FDA require certification for quality system internal audit for auditor? Qualification and Validation (including 21 CFR Part 11) 1
I If i do not want to be an initial importer should i register with FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
B When FDA Decision Summary opens? US Food and Drug Administration (FDA) 4
Ed Panek FDA Remote Regulatory Assessment (RRA) Overview 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 10
B What is the difference btw RUO vs IUO for IVD in FDA guidance ? US Food and Drug Administration (FDA) 12
B How to submit Pre-submission to FDA? US Food and Drug Administration (FDA) 4
L FDA & 21 CFR Part 11 Medical Device and FDA Regulations and Standards News 19
B A.I. diagnostic software is considered as medical device in FDA? US Food and Drug Administration (FDA) 6
Ed Panek 2020 FDA Top Ten Observations 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
M FDA Requirements for Investigational Devices - Clinical Investigation & Shipping Medical Device and FDA Regulations and Standards News 0
Ed Panek Does this FDA Requirement Apply to international (not USA) distributors for USA based manufacturing companies? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
B FDA Breakthrough Device can be overlapped with a designated device? US Food and Drug Administration (FDA) 6
pbojsen ISO 13485 Requirements versus FDA product classification and GMP exemptions - Audits ISO 13485:2016 - Medical Device Quality Management Systems 5
S Examples of FDA acceptable Software Design Specification (SDS) Medical Device and FDA Regulations and Standards News 6
F Labelling to comply with both FDA and MDR US Food and Drug Administration (FDA) 6
Watchcat FDA vs NB Fees? Other US Medical Device Regulations 7
K FDA Registration and listing weird situation Medical Device and FDA Regulations and Standards News 4
D FDA Guidance on Computer Software Assurance versus 21 CFR Part 11 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
G Does FDA allows remote approvals of quality documentation. Is there any specific guidance on signing any quality records remotely? Document Control Systems, Procedures, Forms and Templates 1
B Does FDA Registration QSR need to cover non-medical devices for contract repackager? US Food and Drug Administration (FDA) 1
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

Similar threads

Top Bottom