USFDA De Novo Regulatory Submission for Software as a Medical Device (SaMD) Products

Case Study: USFDA De Novo Regulatory Submission for Software as a Medical Device (SaMD) Products

Project Summary:

A US-based medical device company that developed software for cardiovascular applications approached Celegence for support on De Novo Submission. Their product is a software which must be installed on mobile phones to monitor blood pressure and has to be registered as Software as a Medical Device (SaMD).

Project Initiation & Key Objectives:

The project scope included medical device consulting, medical writing services to support a US FDA De Novo submission. It also involved authoring of regulatory intelligence report for international market entry for Software as a Medical Device (SaMD).

Celegence set up a Center of Excellence (CoE) including Subject Matter Experts and Regulatory Analysts located both onshore and offshore to support the regulatory affairs team with De Novo Submissions. The Center of Excellence (CoE) included pool of experts who had to trained on the processes and tools used for the De Novo Submission.

Celegence Solution & Approach:

The Celegence expert team was engaged in the following activities for creating the requisite sections of De Novo for SaMD.

  • Data Mining and Analysis: Analyse the input documents shared by the client team.

  • Authoring the specific sections of De Novo as requested by the regulatory affairs team including analysis of the risk-benefit profile of the product and conducting Risk Benefit determination.

  • Performed extensive searches for the customer to look for Competitor products/devices to enable them to make an informed decision on going ahead with the De Novo Application.

  • Support on the compilation of documents and submission through the eSTAR template.

  • Identification of Special Controls applicable to the product.

  • Keeping up to date with the new versions of guidance documents issued by FDA and applicable to the product. The client team was made aware of the new guidance and standards applicable as a part of the project.

  • Support on classification and registration of the product in other regions along with USA.

Project Outcomes

The key aspects of the project outcomes involved:

  • 1

    The drafted requisite sections helped the team in successful application for De Novo Submission.

  • 2

    Clients team was happy with Celegence’s regulatory expertise support and awarded a full Customer satisfaction score.

  • 3

    The leadership team further extended their partnership with Celegence and asked to create a Regulatory Intelligence Report identifying different regions across the world where the product can be launched.

Project Success

Celegence’s Subject Matter Experts and Regulatory Analysts successfully supported the client on USFDA De Novo submission.

US FDA De Novo Submission Specialists – Celegence provides regulatory strategy consulting and can help you navigate the complexities of FDA guidance interpretation and FDA interactions. If you need any assistance with eSTAR FDA submissions or De Novo submissions then reach out to us at or for more information contact us online.