April 3, 2023

Regulatory Review of Marketing Literature and other DHF Elements

Virtually all aspects of design and development are officially regulated activities, especially labeling/advertising development.  Moreover, the quality management system demands that all personnel whose work can affect compliance shall be competent regarding their respective assignments.  But even if sales and marketing (or other functional group) believes they have the regulatory qualifications and experience to replace or exclude the actual regulatory contributor, it remains that the quality management system requirements for responsibility and authority don’t generally allow regulatory to be cut out.  This is because there is required to be independence between the compliance function and operating functions like sales & marketing, manufacturing, engineering, etc.  This is to avoid conflicts of interest, and to ensure proper checks and balances; not because regulatory says so, but because regulatory requirements demand such impartiality.

Excluding regulatory from the review of sales and marketing literature (i.e., medical device labeling) is a classic and proven recipe for misbranded (i.e., illegal) medical devices.  The regulations themselves don’t believe that medical device labeling can be consistently safe in the absence of regulatory controls.

There may be more flexibility regarding other DHF documents like verification and validation documents.  For example, I actually recommend and prefer that engineering become the organization’s experts regarding things like software life-cycle development, electrical safety, usability engineering, process validation, and so on.  Proper training and qualifications in those areas can enable more autonomy apart from regulatory.  Yet ultimately, regulatory should still be a contributor and signatory for those, as they are vital elements of successful premarket submissions.

I question the notion that having regulatory on the approval routing somehow adds significant burden to the approval process.  To those lobbying for exclusion of regulatory from the approval routing, I would be interested to know their basis for the questionable notion that regulatory review is adding significant delays.  If delays are happening because regulatory is discovering deficiencies in the documents, then the onus is on the other departments to become better qualified and proficient in those areas.  On the other hand, if delays are happening because the documents are logistically/administratively stalled in regulatory’s queue awaiting review, then regulatory needs to implement a policy whereby it always expedites these reviews and approvals, such that the documents are only in regulatory’s queue in fleeting fashion.

Ultimately, having a proper culture of quality and compliance is key.  Indeed for example, FDA reminds us that there could be a tendency to focus only on the time and effort required in developing and incorporating the controls into the design process. But we should keep in mind the intrinsic value of design controls too. It is a well established fact that the cost to correct design errors is lower when errors are detected early in the design and development process.  History has proven this out, where lack of proper regulatory/quality oversight has been proven to lead to increased recalls and compromised public health.