Kevin Randall New Product, Changed Product. What’s the “legal” difference?
_______________________________________________________________

U.S. medical product statutes refer specifically to “new” drugs, but they do not specifically refer to “new” devices. Nonetheless, certain sections of the U.S. medical device statutes (i.e., the Federal Food, Drug, and Cosmetic Act) and corresponding regulations address the foundations for various notions of new devices. Specifically, the most common of those are (but are not limited to):

• Sec. 510 of the Act [U.S.C sec. 360] addressing device establishment registration, device listing, and premarket notification of devices marketed for the first time, including changed devices
• Sec. 513 of the Act [U.S.C sec. 360c] addressing device classification, including automatic class III designation of unprecedented devices and de novo reclassification
• Sec. 515 of the Act [U.S.C sec. 360e] addressing premarket approval of class III devices
• Sec. 520 of the Act [U.S.C sec. 360j, clause b] addressing custom devices
• Sec. 520 of the Act [U.S.C sec. 360j, clause f] addressing GMP controls for devices
• Sec. 520 of the Act [U.S.C sec. 360j, clause g] addressing investigational devices
• Sec. 520 of the Act [U.S.C sec. 360j, clause m] addressing humanitarian use devices

With those statutory parameters stated (thank you for your patience), one can more carefully and effectively distinguish a firm’s obligations regarding “new” versus changed medical devices. Specifically, regardless of whether a device is the inaugural version or a subsequent iteration realized via ECO, the firm must assure that the resulting variant is in compliance with any fundamental statutory obligation that applies. But as alluded to before, the statutes don’t clearly distinguish an inaugural device version from a changed device [notwithstanding 21 CFR 807.81(a)(3) and 21 CFR 814.39 specifically addressing premarket notification/approval requirements of modified devices].

So practically speaking, if the firm is marketing or investigating a variation of a device for the first time ever (regardless of whether it is the inaugural parent model or a modified off-shoot), then the firm must be sure to consider and satisfy all applicable requirements for investigational use, classification, registration, listing, premarket submissions, and GMP’s (such as new or revised design controls, new DMR’s), etc. The firm’s change control mechanism needs to include systematic attention to these thresholds and obligations in order to maximize the chances that the firm will remain in compliance throughout the device lifecycle.

Hope this helps,

Kevin Randall, ASQ CQA, RAC (U.S., CAN, EU)

Copyright 2015 by ComplianceAcuity, Inc. All rights reserved.

Anil Bhalani On the device front:

I am not going to get into a long essay here. Please refer to the FDA Guidance "When to Submit a 510(k) for a Change to an Existing Device...." at the following link. It will answer your question on what is a New Device and a product changed by an ECO. If this does not help answer your question, hire a consultant!

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080235.htm

In my words:
New Product: One that is not approved/cleared by the FDA or that is approved/cleared by the FDA as submitted with no changes.
Changed Product: New Product that is changed/redesigned etc. etc.

Ronald C. Allen, Ph.D. New Product? Anil has provided the answer and has provided the source.

Gary Chuven Agreed. Anil nailed it.

Kevin Randall A few words of caution about oversimplifying Clyde’s question: Clyde asked “What is the LEGAL definition of a New Product as opposed to a product changed by an ECO?” (emphasis added). But this is not the question answered by FDA’s January 10, 1997 guidance document called “Deciding When to Submit a 510(k) for a Change to an Existing Device”, which instead answers the question indicated in the document’s title. The purpose of the 1997 FDA guidance document is absolutely NOT aimed at distinguishing “new” devices from devices realized via ECO.

Indeed, the U.S. device statutes and regulations define “device” as well as characterize devices that have been “significantly changed or modified…” But they DO NOT define “new” device. Therefore, readers should avoid managing their quality systems and/or making regulatory decisions based on the common practical notion of “new” device, as this notion is legally-subjective and statutorily-ambiguous. Even the cited 1997 FDA guidance document demonstrates this fact by offering multiple examples of significant device changes requiring a new 510(k), yet that don’t seem to result in the common notion of “new” device. Specifically, altering device contraindications, using different materials of construction warranting additional ISO 10993 testing, changing the lethality of the sterilization process, and other scenarios too.

Admittedly, the 1997 FDA guidance document is certainly very useful in its own right; I rely on it frequently when consulting my clients. However, readers should remember FDA’s official position conveyed in 21 CFR part 10, which reminds us that FDA guidance documents, “…DO NOT ESTABLISH LEGALLY ENFORCEABLE RIGHTS OR RESPONSIBILITIES. THEY DO NOT LEGALLY BIND THE PUBLIC OR FDA” (emphasis added). Moreover, FDA does not seem to be fully satisfied with the 1997 guidance. Remember the Agency’s efforts to revise it in July 2011? (draft now rescinded). And although FDA reported to Congress in early 2014 that the 1997 guidance remains a “solid foundation”, the FDA maintained its stance that the 1997 guidance still needs revision. For example, FDA said that it still plans revisions aimed at clarifying terms; addressing use of quality systems in change-decisions; UPDATING THE 1997 FLOWCHARTS; adding device-specific recommendations; and better addressing software changes.

The ultimate legal boundaries within which FDA must operate are the U.S. statutes and implementing regulations, period. Don't make the mistake of coronating any FDA guidance document as the ultimate authority (legal or otherwise) under which your firm is governed.

Hope this helps,

Kevin Randall, ASQ CQA, RAC (U.S., CAN, EU)

Copyright 2015 by ComplianceAcuity, Inc. All rights reserved.