ComplianceOnline

📢 Join Us for an Essential Seminar on SOP Writing, Training, and Compliance in the Pharmaceutical Industry!

💡 What You’ll Learn:
🔹 Best practices for defining and documenting processes.
🔹 Tools and techniques for making SOPs efficient and easy to follow.
🔹 Strategies to integrate SOPs into employee training curricula.
🔹 Tips for improving SOP knowledge retention and compliance.

𝐓𝐡𝐞 𝐔𝐒 𝐅𝐃𝐀 𝐚𝐧𝐝 𝐀𝐈 𝐃𝐞𝐯𝐢𝐜𝐞𝐬

By: John E. Lincoln, consultant, J. E. Lincoln and Associates LLC,
www.jelincoln.com

The US FDA has announced steps toward a new regulatory framework to promote the development of medical devices that use advanced artificial intelligence / machine learning algorithms - AI algorithms that can learn from and act on data. They have
already authorized some devices having AI capabilities. Their AI Good Machine Learning Practice lists 10 “guiding principles” for ML/AI¹ to apply FDA’s current authorities in new ways to keep up with the rapid pace of innovation and still ensure device safety and performance.

The Agency is looking beyond elemental “locked” algorithm AI devices – devices that don’t continually adapt or learn - to “true” AI - machine learning algorithms that continually evolve, often called “adaptive” or “continuously learning” algorithms, that learn through real-world use. The FDA is exploring a framework to allow modifications to algorithms to be made from real-world learning and adaptation, while still ensuring safety and effectiveness of the software required for pre-market review. They include the
algorithm’s performance, the added concerns for AI / ML software verification and validation, the manufacturer’s plan for modifications, and the ability of the manufacturer
to manage and control risks of the modifications, including the software’s "predetermined change control plan".

¹ https://www.fda.gov/medical-devices/software-medical-device-samd/good-machine-learning-practice-medical-device-development-guiding-principles

Bᴇʟᴏᴡ ɪs ᴛʜᴇ ʀᴇʟᴀᴛᴇᴅ ᴡᴇʙɪɴᴀʀ ᴛʀᴀɪɴɪɴɢ ᴏɴ ᴛʜɪs ᴛᴏᴘɪᴄ

https://bit.ly/3zyF8dW

US FDA's AI Framework for Medical Devices : Compliance Training Webinar (Online Seminar) - ComplianceOnline.com The US FDA has announced steps toward a new regulatory framework specifically tailored to promote the development of safe and effective medical devices that use advanced artificial intelligence / machine learning algorithms. Artificial intelligence algorithms are software that can learn from and act...

𝐀𝐮𝐝𝐢𝐭𝐬 - 𝐒𝐞𝐥𝐟/𝐈𝐧𝐭𝐞𝐫𝐧𝐚𝐥, 𝐕𝐞𝐧𝐝𝐨𝐫 𝐚𝐧𝐝 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐈𝐧𝐬𝐩𝐞𝐜𝐭𝐢𝐨𝐧𝐬

Oɴᴇ Dᴀʏ Vɪʀᴛᴜᴀʟ Sᴇᴍɪɴᴀʀ by John E Lincoln

Date & Time : March 03, 2025 (10:00 AM ET – 4:00 PM ET)

US FDA statements and actions indicate the initial and purpose of Part 11 "Add-on" inspections are being extended beyond what was to be a short term review of industry's response to Part 11. Using the field tested techniques presented in this webinar, an internal and/or supplier audit can provide much the same early warnings as a real FDA compliance CGMP audit. This seminar will provide test scripts and rationale for a "model" for company internal and supplier audits.

𝙑𝙞𝙚𝙬 𝘿𝙚𝙩𝙖𝙞𝙡𝙨 - https://www.complianceonline.com/audits-self-internal-vendor-and-regulatory-inspections-seminar-training-80676SEM-prdsm?channel=organic_FB

𝐃𝐞𝐯𝐢𝐜𝐞 𝐃𝐇𝐅𝐬, 𝐃𝐞𝐯𝐢𝐜𝐞 𝐂𝐡𝐚𝐧𝐠𝐞𝐬, 𝐂𝐑’𝐬, 𝐚𝐧𝐝 𝐭𝐡𝐞 𝟓𝟏𝟎(𝐤)

By: John E. Lincoln, consultant, J. E. Lincoln and Associates LLC,
www.jelincoln.com

There are many ways to meet the requirements of Device change orders and the
Design History File (820.30); the Device Master Record (DMR, 820.1811); and the Device History Record (DHR, 820.184) required by the Device CGMPs. The following is one field tested approach.

Many companies start a new DHF for major changes to their device. If minor changes they handle under the CGMPs (Change Control, 820.40(b)). Some keep the original DHF open.
As with most of the points discussed herein, there are more than one correct approach.

Generally the DHF is used for major changes (with each new major change addendum to the original DHF, or a new, cross-referenced DHF), which require some type of control of a series of development changes per 820.30.

For a minor / simple change, use change control under 820.40(b), which at most companies is under a Change Request / Change Order (the CR when approved, can become the CO). To it are attached the verification / test information / references, e.g.,
test report number / Lab Book Project number, etc., to justify / verify / validate the change, or in very simple changes, the actual data on the CR / CO.

The CO needs to have a block referencing a check for need to file a new 510(k), or not, per two recent
Guidance Documents on device changes and the 510(k), and with the CO also tied to some kind of list / log of changes for the required cumulative change review as well.

Specific requirement per the above would be called out in an SOP(s).

𝙍𝙚𝙡𝙖𝙩𝙚𝙙 𝙏𝙧𝙖𝙞𝙣𝙞𝙣𝙜𝙨 𝙛𝙧𝙤𝙢 𝘾𝙤𝙢𝙥𝙡𝙞𝙖𝙣𝙘𝙚𝙊𝙣𝙡𝙞𝙣𝙚

https://www.complianceonline.com/design-history-files-device-master-records-device-history-records-webinar-training-701898-prdw?channel=organic_FB

https://www.complianceonline.com/the-estar-submission-program-for-510-k-s-ides-de-novos-pmas-and-q-submissions-webinar-training-706968-prdw?channel=organic_FB

https://www.complianceonline.com/installation-and-qualification-of-the-packaging-lines-webinar-training-706996-prdw?channel=organic_FB

https://www.complianceonline.com/design-control-requirements-documents-under-21-cfr-820-30-and-iso-13485-7-3-webinar-training-706923-prdw?channel=organic_FB

J E Lincoln and Associates Worry Now

𝐅𝐃𝐀 𝐈𝐬𝐬𝐮𝐞𝐬 𝐐𝐮𝐚𝐥𝐢𝐭𝐲 𝐌𝐚𝐧𝐚𝐠𝐞𝐦𝐞𝐧𝐭 𝐒𝐲𝐬𝐭𝐞𝐦 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐢𝐨𝐧 (𝐐𝐌𝐒𝐑): 𝐅𝐢𝐧𝐚𝐥 𝐑𝐮𝐥𝐞 𝐀𝐦𝐞𝐧𝐝𝐢𝐧𝐠 𝐭𝐡𝐞 𝐐𝐮𝐚𝐥𝐢𝐭𝐲 𝐒𝐲𝐬𝐭𝐞𝐦 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐢𝐨𝐧 (𝐐𝐒𝐑)

By: John E. Lincoln, consultant, J. E. Lincoln and Associates LLC, www.jelincoln.com

https://bit.ly/47tubqz

On February 2, 2024, the US FDA published its long awaited amended device Quality Management System Regulation (QMSR; CGMPS) in the Federal Register. It’s stated
purpose is “[t]o ensure medical devices on the market are safe, effective, and of good
quality ...”

The QMSR rule emphasizes risk management activities and risk-based decision making (ISO 14971:2019, patient and user safety) and reduces regulatory burdens on device manufacturers and importers by harmonizing domestic (21 CFR 820, Device CGMPs)
and international requirements (ISO 13485, device QMS, and ISO 9000, Clause 3 Definitions, both included in the revised 21 CFR 820 by reference). As a result, 820 has been gutted and replaced by ISO 13485. The new 820 Subparts A and B, emphasize requirements of the US Food, Drug and Cosmetic Act that are not fully addressed in ISO 13485.

The FDA stated that this change should not result in any substantive changes to a company’s existing QMS, except SOP CGMP references and terminology / definitions. However, there is no mutual recognition of another country’s regulatory inspection of
ISO 13485, and vice versa.

Notable changes: In the Preamble, the FDA has indicated that it will no longer exempt a company’s internal audit and management review findings from their inspections.
Obviously, SOP references (to ISO 13485 primarily, and definitions (to ISO 9000, Clause 3) will also change.

Device manufacturers and importers will have two years to modify their Quality Systems to meet the requirements of the QMSR rule, by February 2, 2026. Until then, manufacturers are required to comply with the existing Quality System regulation.

More info on this is discussed in the following training https://bit.ly/47tubqz

Related trainings on this article can be found below
https://www.complianceonline.com/the-new-us-fda-21-cfr-820-quality-management-system-regulation-qmsr-medical-device-cgmps-webinar-training-706961-prdw?channel=organic_FB

https://www.complianceonline.com/us-fda-medical-device-qsr-21-cfr-820-and-quality-management-system-webinar-training-705794-prdw?channel=organic_FB

https://www.complianceonline.com/quality-management-system-current-proposed-major-changes-qsr-21-cfr-820-medical-device-webinar-training-706950-prdw?channel=organic_FB

https://www.complianceonline.com/risk-based-verification-and-validation-planning-to-meet-us-fda-and-iso-13485-requirements-webinar-training-700149-prdw?channel=organic_FB

The New US FDA 21 CFR 820, Quality Management System Regulation (QMSR), Medical Device CGMPs : Compliance Training Webinar (Online Seminar) - ComplianceOnline.com This webinar will discuss what the new QMSR will require. A key element is the incorporation of ISO 13485 into the new 820 by reference. Major emphasis will be upon risk management in accordance with ISO 14971

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