The purpose of this article is to show how a Quality leader can establish the external requirements of an organization’s management system by first defining the products marketed in a particular country or geographic area. The example will be the determination of medical devices, referring to the FDA regulation Section 201(h), using the 513g Request process. Following this process will prevent the organization from losing time and wasting precious funds and resources on improperly calibrated assumptions of regulatory expectations. 

My sources for this summary are directly available online from the FDA, specifically describing the purposes and sequences of this request process. I recommend a careful review of these updated items before proceeding with this particular request process. 

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-and-industry-procedures-section-513g-requests-information-under-federal-food-drug-and-cosmetic  

https://www.fda.gov/media/78456/download 

https://www.fda.gov/media/133229/download  

Earlier in my career, I was a Quality and Regulatory Affairs Manager for a product development company which designed and produced biomedical engineering items with integrated software and hardware components. These items, intended for use in clinical and laboratory environments, were designed with functions and features which included data capture, data analysis, data reporting, and alarms for particular medical conditions. I had a vested interest to know how these products would be identified and categorized within international markets, and the extent of preparation and diligence needed. 

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As an entrepreneurial organization, there were incentives and directives to get the functional products to a point where these items could be available for revenue-generating commercial activity. Among the barriers to entry were the steps needed to confirm regulatory clearance. As an imported product, inadequate clearance would obstruct the shipment and usage of such products. 

Once a product is deemed to be a medical device as defined by a regulation like the FDA’s Section 201(h), there are potentially more commitments and obligations placed on the organization for its product. The intended uses of such devices typically relate to diagnosis, cure, mitigation, treatment, or prevention of health maladies, or modifications to the structure or function of physical characteristics. 

The extent to which the device possesses these attributes is determined by the details provided within a 513g request. This is based on the description of the device, the description of what the device is used for, and promotional material examples showing how it could be labelled and marketed. The level of detail should include any components (i.e. software, firmware, critical hardware), the purposes and frequency of intended use, and the environment or patient population. 

My experience with the 513g process was positive and beneficial to the organization. Since I submitted a portfolio of products, FDA was able to discern the distinct profiles for each product and recommend the appropriate regulatory pathways commensurate with the perceived risks. These were based on precedents of similar or “substantially equivalent” devices already in the market. I have since learned that the FDA also offers a more rapid inquiry process by emailing DeviceDetermination@fda.hhs.gov. 

If the item is determined to not be a medical device, the FDA does not have jurisdiction. However, this does not fully absolve the organization, as electronic devices may be subjected to additional clearance protocols from FCC or its equivalent international bodies (i.e. CE Mark for Europe). If the intended uses and purposes are determined to be characteristic of a medical device, the identified risk levels will specify the regulatory burdens required for fulfilment by the organization. 

The items with the lowest risk will be categorized as Class I, and are exempt from a Pre-Market Notification approval. While there are still requirements for the organization to demonstrate its management systems and product assurance practices, the barriers to entry for commercial purposes are more manageable. 

At levels of higher risk, FDA will either require Pre-Market Notification or Pre-Market Approvals. These are of such significance that specialized regulatory skills and capabilities are employed. The expectations to complete such requirements will be defined by the objective evidence provided for consideration. The Quality leader can work with the organization to revise the product scope and purpose in order to adjust the risk categorization.  

Using the analogy of downgrading a horror movie from being X-rated to PG-rated, this might entail the filmmaker removing some profanities and modifying graphic scenes within the footage to make the final cut more acceptable. In a similar manner, the organization can reduce or remove certain features or purposes to reduce the overall risk classification. Alternatively, different models of the same product could be developed, isolating the highest risk medical devices to a subset of users while versions with a moderate risk could be brought to market earlier. 

The 513g process is helpful because it provides objectivity and clarity to the organization for its intended product. From the viewpoint of Product Management, the definition of the risk and regulatory burden can impact the potential time to market, revenue growth, and rate of adoption. It can also help to differentiate the new product from its competing alternatives in order promote its unique medical characteristics. These decisions drive quality and customer satisfaction. 

My experience was also positive because the 513g process could be leveraged across other geographic markets. When the items or devices were submitted for consideration, the 513g evaluation was included to substantiate that certain products were either not medical devices or medical devices with lower perceived risk. This reduced the overall regulatory burden of the product portfolio, putting some items on a faster track toward marketability and revenue generation. 

To summarize, a quality leader should take steps to understand how their product or system could be regulated within a particular market or geography. Rather than attempt to research independently or obtain “false positive” evaluations from AI, a more prudent approach is to contact the regulatory source directly for objective recommendations based on updated standards and practices. Once the organization has received confirmation, this valid manifestation can be used internally to justify the efforts and resource commitments needed to address imperative necessity of adequate management systems, ongoing verification and validation, and documented product design files.