We help medical device companies obtain FDA authorization through 510(k) and De Novo submissions, and expand access to global markets.
SANRUBIO Medical Devices Consulting provides specialized support in FDA regulatory submissions, U.S. medical device registration pathways, and post-market compliance.
In a highly regulated industry, we offer FDA-compliant quality systems and expert guidance to simplify complex compliance challenges.
01 Regulatory Consulting
Comprehensive assessments to ensure your medical device meets regulatory standards before initiating the FDA registration process, including 510(k) or De Novo submissions.
02 Medical device registration
We guide you through every stage of FDA registration, from 510(k) and De Novo submissions to compliance with all regulatory requirements, ensuring an efficient and successful process.
03 Quality Management System
Development and adaptation of QMS to align with ISO 13485, FDA (21 CFR 820), and global standards for market access.
04 US Agent & Establishment Registration and Device Listing
We facilitate your access to the U.S. market by providing Registered Agent services and establishment registration.
Comply with FDA regulatory requirements for manufacturers with our expert support.
How we work
Contact us
Personalized consulting tailored to your objectives. Contact us to develop a custom regulatory strategy.
Preliminary Assessment
Review your technical documentation to identify gaps and ensure alignment with FDA and international standards.
Submission
Our team manages the preparation and submission of the necessary documentation, ensuring a streamlined process in full compliance with applicable regulations.
01
What is a 510(k) submission and when do you need one for your medical device?
The 510(k) is a regulatory clearance process that requires demonstrating your device is substantially equivalent to an already approved one (known as a predicate device). It primarily applies to moderate-risk devices (Class II) and certain Class I devices.
02
What happens if the FDA rejects my 510(k) submission?
You may receive a “Not Substantially Equivalent” (NSE) letter. This is not the end of the road, you can revise and resubmit a new 510(k) application or choose to apply through the De Novo pathway - if applicable.
03
When should I use the De Novo pathway instead of the 510(k)?
The De Novo process is designed for innovative devices without a predicate device but with low to moderate risk. It’s ideal when your technology has no equivalent currently on the market.
04
What are the FDA submission fees?
Fiscal year 2026 (October 2025– September 2026):
Establishment registration: $11,423
510(K) submission:
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Standard fee: $26,067
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Small business fee: $6,517
De Novo submission:
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Standard fee: $173,782
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Small business fee: $43,446
The small business fee applies to companies with annual revenues under $100 million.
05
How long does it take to get FDA approval?
510(k) Submission: 3 to 6 months
De Novo Submission: 6 to 12 months
Establishment registration: 1 to 5 business day
These timeframes are estimates and may be affected by requests for additional evidence or FDA workload.
