Background

A European blood glucose meter manufacturing company identified the need for a regulatory strategy to help their product get to the market. They were looking for a regulatory consulting firm that can provide continued support and ability to meet stringent deadlines. 

Challenges

The following were the challenges faced by the client:

1. Pathway to market 

Even though the blood glucose system is a well known device, however, there exist many pathways to the market for this device. FDA has regulated such products under Class I,  II, or III, depending on the specific indications for use and the source of assessment (like the whole blood). The Client consisted of a team of clinical and laboratory experts but they were not sure on how to analyse the regulatory path that would be the best for the product. 

2. OTC vs Rx  

The Client wanted to know what it would take to get the product to the market under an OTC label. The Client knew that an OTC label would certainly need many other tests which would not be applicable for a prescription only use (Rx only), but wanted specific guidance on what these tests would be and which test labs could perform these efficiently.  

3. Required testing 

The Client wanted to know what testing would be essential for the IVD and to what extent those would have to be conducted. The Client also wanted to understand how they can set up the acceptance criteria for testing, and what considerations would be important from a regulatory standpoint.  

Solutions

1. Pathway to the market – Deciphering the regulations

Elexes Team assessed and understood that the glucose test system was intended to measure glucose quantitatively in blood samples taken from fresh capillary whole blood from the finger, and from venous and arterial whole blood (outside the body, in vitro diagnostic device setting). Based on this, other specific claims, the technological characteristics, the fact that the device was meant to be sold over the counter, and considering the regulatory framework, Elexes determined the product code applicable to the device to be NBW. On the basis of this assessment, 510(k) pathway was decided to be an apt regulatory submission to be pursued. 

2. OTC vs Rx – choice for labelling

Since the Client wanted to market the product as an over-the-counter (OTC) device, Elexes advised on conducting a use Failure Mode Effect Analysis (FMEA) to analyse the human factors related sources of errors, like lighting, glare off meter surfaces, visual and auditory distractions, stressful conditions in a home setting, and limited manual dexterity of the potential users. Based on the assessment, available predicates, 510k framework, and various usability expectations of the FDA, Elexes deciphered and suggested whether or not a usability study is needed. 

3. Performance testing – how much is enough 

By conducting a comprehensive analysis of the product and its functionalities, Elexes advised on various performance tests that the Client should perform for the upcoming regulatory submission. 

Some of these tests were: 

• Precision tests
• Linearity evaluation tests 
• Sample perturbation study 
• Interference evaluation 
• Performance testing 
• Accuracy testing 

When recommending the tests that are to be conducted, Elexes performed a thorough evaluation of potential and existing device failures that have been observed, risk assessment, and brainstorming with the Client’s product team. Elexes worked with the Client’s product team to suggest acceptance criteria considering past experiences and various ISO and other standards applicable to the device, and also provided a format that FDA expects for all such tests. 

Results

As a result of continuous efforts and with Elexes’ regulatory and quality expertise, all the Clients’ requirements were quickly addressed, and the product underwent the right amount of testing within a desired time frame. This helped the company get their product to the market in the most efficient way. 

Key Takeaway

Regulatory strategy and project management is very important for all medical device and IVD manufacturers. The appropriate strategy for submissions and the right amount of testing saves a lot of time and effort and helps get to the market timely.