CAPTIS™: MDD to MDR CER Remediation of a Standalone Software
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).
Celegence Solution & Approach:
The Celegence expert team was engaged in the following activities for creating the requisite sections of De Novo for SaMD.
Highlights:
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 Achievements
Project Success
Celegence’s Subject Matter Experts and Regulatory Analysts successfully supported the client on USFDA De Novo submission. 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..
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 info@celegence.com or for more information contact us online.
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25 Mar, 2025
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