For the device sector, the U.S. medical device laws (via the FD&C Act) are promulgated into regulations (i.e., "regulatory" requirements). Yet such "regulatory" requirements for medical device establishment reporting structure and organization are codified within the current "Quality" System Regulation (soon to become the Quality Management System Regulation). Accordingly, FDA medical device organization "regulatory" and "quality" are like two sides of the same coin, where they aren't necessarily separated by FDA's medical device regulations.
For example, FDA expects the applicable "regulatory affairs" and associated regulatory organization functions (e.g., premarket regulatory clearances/approvals) to be elucidated and addressed within the medical device design process of the "Quality" System "Regulation", again reminding us of the inseparable statutory/regulatory link between medical device regulatory and quality affairs. Accordingly, you will find some organizations where the quality and regulatory functions are consolidated wtihin the same department, while in others, they are separated.
With respect to conflicts of interest, FDA ultimately requires that a medical device firm shall assure "organizational freedom" and "independence" to perform and assess work affecting "quality" (which, as noted before, statutorily encompasses "regulatory"). FDA says that said organizational freedom and independence doesn't necessarily require a stand-alone group. Indeed, some firms only have a single employee or just a few. However, in my opinion, a stand-alone department (or at least functional separation on an organizational chart) is the most sensible and practical way to deal with FDA's requirement for "organizational freedom" and "independence".
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Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
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Original Message:
Sent: 24-Jul-2023 15:13
From: Dan O'Leary
Subject: Organizational chart and reporting structure
The answer depends on whether the product is a device or a pharmaceutical. It also depends on the relationship between Quality and Regulatory.
For pharmaceuticals there must be a separate quality organization. Devices don't have a requirement for a quality organization, but do have a requirement for a Management Representative. The Management Representative is commonly the quality manager, but that is not required. (I've worked with two device companies where the Management Representative was the Financial Controller.)
Some companies combine quality and regulatory into one organization while others split them out. When combined, the quality organization requirements govern.
I don't know of any requirements to have a regulatory organization.<o:p></o:p>
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Dan O'Leary CQA, CQE
Swanzey NH
United States
Original Message:
Sent: 24-Jul-2023 14:48
From: Bani Tchekanova
Subject: Organizational chart and reporting structure
Question is what is FDA's expectation in terms of Regulatory department and the reporting structure (org chart)? considering compliance and conflict of interst in mind. What is everyone's experience on this?
I appreciate the feedback.
Sincerely,
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Bani Tchekanova
Escondido CA
United States
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