Hi Hans,
Thanks for your addition in the table, it is really helpful.
Moreover, the
CSV and Risk Analysis you have added in U.S requirement?
as per my knowledge risk assessment have to be followed for e-ifu EU requirements.
Thanks once again.
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Rabel Talpur
Freiburg
Germany
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Original Message:
Sent: 01-Feb-2022 08:33
From: Hans Strobel
Subject: Comments on e-ifu comparion (U.S and EU)
Hello Rabel
Good approach and question. If made some addition and comments to your table. Might not be complete yet but a step forward. Check my post on eIFU regulations some weeks ago for regulations. You can also contact me.
Kind regards,
Hans
Contents | e-IFU (EU Requirements) | U.S FDA |
Accepted format | - Text, video, audio files & Hard copy (if requested) - website interface text in national language of the market - Portable electronic storage (provided by manufacturer) with device -E-ifu access via particular software - hard copy if requested within 7 calendar days - ifu available on the company website (including previous eIFU Versions), website requirements listed below apply | - Adobe Acrobat or Rich Text Format (RTF possible but must meet Part 11 requirements) - web site download, on a compact disc (CD) or on USB. - Hard copy (if requested) - all regulated by 21 CFR Part 11 and Medical Device User Fee and Modernization Act Sec. 206 |
Acceptable Media | - Web-site or web hosting service - Portable storage - Via software (requires an additional source, e.g. website) | FDA's eSubmitter software - Electronic submission via FDA's Electronic Submissions Gateway (ESG). -prepare documents on CD via e-submitter software and send to CDRH -Hard Copy (When requested) |
Website Requirements | - Protection against software & hardware intrusion - IFU be provided in commonly used format and on free readable software - Languages in which e-IFU is available -Compliance with Directive 2016/679 (Data Protection Directive). - Old IFUs must be available on the website with date | - CSV (Computer System Validation) |
e-IFU Requirements / QA | - Indicate that the instructions for use supplied in electronic version - Information on how to access an e-IFU - E-IFU shall be provided in text format with the similarity with paper based IFU - Manufacturer shall undertake a documented risk assessment - Provide e-IFu in all member state where device is available - System to provide paper based IFU; when requested - information related to starting a device and foreseeable medical emergency situations on device or on leaflet. - Validation & verification proof of the functionality of an e-IFU - information on software and hardware requirements needed to display the instructions for use - system in place to clearly indicate when the instructions for use have been revised - Devices with a defined expiry date shall keep e-ifu to accessible to user after the expiry (2 years after expiration) - Devices without a defined expiry date shall keep e-ifu to accessible to user after the expiry (15 years after expiration) |
- Risk analysis - CSV (Computer System Validation) |
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Hans Strobel
www.dokspot.io
Original Message:
Sent: 31-Jan-2022 07:23
From: Rabel Talpur
Subject: Comments on e-ifu comparion (U.S and EU)
Dear RA experts,
your kind suggestion are required on this e-ifu comparison chart (EU & U.S):
Contents | e-IFU (EU Requirements) | U.S FDA |
Accepted format | - Text, video, audio files & Hard copy (if requested) - Portable electronic storage (provided by manufacturer) with device -E-ifu access via particular software | - Adobe Acrobat or Rich Text Format - web site download, on a compact disc (CD) or on USB. - Hard copy (if requested) |
Acceptable Media | - Web-site or web hosting service - Portable storage - Via software | FDA's eSubmitter software - Electronic submission via FDA's Electronic Submissions Gateway (ESG). -prepare documents on CD via e-submitter software and send to CDRH -Hard Copy (When requested) |
Website Requirements | - Protection against software & hardware intrusion - IFU be provided in commonly used format and on free readable software - Languages in which e-IFU is available -Compliance with Directive 95/46/EC (Data Protection Directive). - Old IFUs must be mentioned on the website with date | NA |
e-IFU Requirements | - Indicate that the instructions for use supplied in electronic version - Information on how to access an e-IFU - E-IFU shall be provided in text format with the similarity with paper based IFU - Manufacturer shall undertake a documented risk assessment - Provide e-IFu in all member state where device is available - System to provide paper based IFU; when requested - information related to starting a device and foreseeable medical emergency situations on device or on leaflet. - Validation & verification proof of the functionality of an e-IFU - information on software and hardware requirements needed to display the instructions for use - system in place to clearly indicate when the instructions for use have been revised - Devices with a defined expiry date shall keep e-ifu to accessible to user after the expiry (2 years after expiration) - Devices without a defined expiry date shall keep e-ifu to accessible to user after the expiry (15 years after expiration) | IFU- Requirements for U.S Please follow the Medical Device labelling requirements: https://www.fda.gov/medical-devices/overview-device-regulation/device-labeling |
| | |
Looking forward for suggestions, if any information is missing.
Best Regards,
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Rabel Talpur
Freiburg
Germany
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