December 26, 2022

Successful 510k filing with the US FDA


A high quality cost effective solution for Software as a Medical Device (SaMD) companies


A company was looking to solve some unique problems in the cardiology space. The first product that this company was developing was an ECG analysis solution that would enable diagnosis of arrhythmia. The solution offered cloud sync for an easy accessibility of information from any location, and was powered by deep learning technology.   

The company decided to utilize Elexes as their global regulatory partner to assist them in “go to market strategy” and obtain 510(k) clearance with the US FDA.


  1. Product Assessment – Absence of regulatory expertise

Since the Client consisted of personnel who were from a core software development field, they were unaware of various regulatory and quality systems requirements that can be applied during product development and assessment phase to set oneself up for success. 

  1. Risk identification and mitigation – Absence of a risk assessment ownership 

While the Client had a Physician on the team who was well aware of the risks and general mitigation measures associated with the product, no one was available to take the ownership of risk assessment and keep that document live throughout the lifecycle of the product. 

  1. Predicate device(s) – A need to identify the appropriate predicate 

There was much of a need for due diligence to read through the various products on the market and assess which product would be the best future predicate for the 510k clearance. This required dedicated efforts, but the client was focussed on product development. 


  1. Product Assessment – Configure the design and regulatory process

Elexes assessed the product in detail. Based on the technological characteristics, compatible systems, indications of use, target patient population, and clinical application, Elexes suggested the essential performances of the product. Elexes made the Client aware of the following: 

  • Design of experimentation (DoE)
  • Setting up acceptance criteria considering industry wide standards 
  • Creating specifications such that the product meets the clinical requirements 
  • Software requirements specifications, design specifications, V&V
  • Ongoing traceability when developing various software versions
  • Design controls and design freeze
  • Locked vs. adaptive AI/ML based SaMD 
  1. Risk identification and mitigation – Establishment of the risk management process

Elexes ensured that all risks associated with the product have been identified with their respective control measures and that the risks were reduced to as far as possible. Elexes helped Client utilize the principles of ISO 14971 for putting together a comprehensive risk management file that consisted of a risk management plan, FMEAs and other related documents. Elexes took ownership of keeping the risk management file live throughout the product’s lifecycle, considering inputs from the clinical study, integration, unit and other verification testing, and feedback that the product received.   

  1. Predicate device(s) – Identification of an appropriate predicate 

Elexes did a thorough assessment of devices on the market, and identified the best suitable predicate considering various factors such as: 

  • Applicable product code
  • Applicable regulations and review panel 
  • Indications for use 
  • Utilized technology 

Elexes ensured that the Client’s product gets through all the critical decision points as per the below flowchart to ultimately get a successful 510k clearance. 


As a result of involvement of a dedicated and competent regulatory partner at an early stage, the Client could get through the FDA clearance process very quickly and efficiently, focusing on what is needed to attain the end goal instead of spending time, money and resources on trial and error. 

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