Regulatory Open Forum

 View Only
  • 1.  Organizational chart and reporting structure

    Posted 24-Jul-2023 14:49

    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. 


    Bani Tchekanova
    Escondido CA
    United States

  • 2.  RE: Organizational chart and reporting structure

    Posted 24-Jul-2023 15:13

    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.

    Dan O'Leary CQA, CQE
    Swanzey NH
    United States

  • 3.  RE: Organizational chart and reporting structure

    Posted 25-Jul-2023 08:53

    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".

    Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
    Principal Consultant
    Ridgway, CO
    United States
    © Copyright 2023 by ComplianceAcuity, Inc. All rights reserved.

  • 4.  RE: Organizational chart and reporting structure

    Posted 25-Jul-2023 09:15

    Hi Bani.

    I have been in several companies (admittedly all on the pharma side so my experience might be less useful for device folks!) over the past 30 years and have seen multiple different org chart decisions over that time.  In Regulatory, I have reported to the VP of Scientific Affairs, the Director of Quality, the Site Director, the Chief Science Officer, and even the Division President.  All that is to say, there is no one "right" way to handle organizational reporting structures.  The key is to be able to show that the reporting structure does not in fact produce even the appearance of conflicts of interest.  So if the organization is set up such that the team is able to adequately support their functional requirements and obtain further review of contentious issues from further up the chain of command or from a lateral leadership review of the issues, that can work for the organization.

    Also, I have been everything from a sole practitioner (originating the Regulatory organization in the business) to leading a team of several more junior members of the team.  This will also have a potential impact on the planned reporting structure and can involve some interesting and different conversations depending on both personalities and on the requirements of the job.  

    Ultimately it is really up to the business to determine what situation works best for that company.  Provided that the regulatory function has sufficient autonomy or has the ability to have conflicts heard by leadership the process should work.  However, if you are in a situation where you are not given that autonomy and you are also not able to escalate effectively to have the issue resolved that is a situation where organizationally you might need to have another look at the structure or you risk losing one or more of your key people.

    Victor Mencarelli MS
    Global Director Regulatory Affairs
    New YorkNY
    United States

  • 5.  RE: Organizational chart and reporting structure

    Posted 25-Jul-2023 16:56

    I can speak from the devices side...

    There are no "FDA expectations" per se on the organization structure. The expectations are somewhat greater on the quaity side for the Management Rep and that the individuals responsible for releasing product have "sufficient authority."

    As for regulatory, so much depends on the larger business structure, size, culture etc. I have been involved with successful FDA inspections with groups where regulatory reported to Legal, Quality, R&D, CTO, President/CEO. Larger organizations may "split" regulatory with a centralized function for some aspects and "Regulatory Operations" reporting to divisional Presidents/GMs. 

    It can also depend on the people. The most regulatory/quality oriented boss I ever reported to was an SVP of RD/Ops/Reg/Quality whose background was R&D. But he had a huge passion for doing things right and his leadership of other functions actually made our jobs easier. And various Presidents/CEOS/GMs I have known have ranged from excellent at understanding Regulatory (or Quality) to viewing regulatory as the "sales prevention department." 

    FDA seems to mostly care "does it work?" Are the proper RA submissions done? Are the proper regulatory SOPs followed? Are UDI etc etc processes in place. Are the submissions accurate? Does regulatory sign the appropriate change orders? Is someone "up the chain" overruling things? If it works, they don't seem to have preconceived notions on how it should be structured.


    Ginger Glaser RAC
    Chief Technology Officer (contrac), Regulatory/Quality Executive Consultant