FDA 510(k) Clearance Consulting in Brazil

Expand Your Medical Device Business into the U.S. Market

FDA 510(k) clearance is a mandatory premarket submission required by the U.S. FDA for most Class II medical devices. It proves that a new device is substantially equivalent to an already cleared device in terms of safety, intended use, and performance. For Brazilian medical device manufacturers, this clearance is the gateway to legally entering and selling in the U.S. market.

What is FDA 510(k) Clearance and Why is it Important?

FDA 510(k) clearance is a regulatory pathway that ensures your medical device meets U.S. standards before it can be marketed.

Why Brazilian manufacturers need it:

Legal approval to distribute devices in the U.S.
Faster market entry compared to FDA PMA (Class III) process
Reduced risk of rejection or delays
Compliance with 21 CFR Part 820 & 807 Quality System Regulations

Step-by-Step FDA 510(k) Clearance Process

We simplify the complex regulatory pathway for Brazilian manufacturers:

Device Classification & Predicate Identification
- Classify your device under FDA rules.
- Select a suitable predicate device to establish equivalence.
Documentation & Testing
- Gather performance, biocompatibility, and safety data.
- Review test reports to match FDA expectations.
Submission Preparation & Review
- Prepare a complete 510(k) dossier with labeling, device description, and test results.
- Internal review to minimize risks of RTA (Refuse to Accept).
FDA Submission & Communication
- Submit directly to FDA.
- Respond promptly to any FDA queries.
Clearance & Post-Market Support
- Receive the official FDA 510(k) Clearance Letter.
- Support with post-market compliance, audits, and surveillance.

Let's Grow Your Business Together

Fill the Form or Mail Us to: enquiry@operonstrategist.com

FDA Medical Device Classification

Class	Risk Level	Examples
Class I	Low Risk (General Controls)	Bandages, hospital furniture
Class II	Moderate Risk (Requires 510(k))	Catheters, surgical gloves
Class III	High Risk (Requires PMA)	Pacemakers, defibrillators

Expand your medical device business into the U.S. with professional FDA 510(k) guidance.

Why Choose Operon Strategist for FDA 510(k) in Brazil?

With over a decade of regulatory expertise, Operon Strategist is trusted by medical device companies worldwide. Our Brazil-focused consulting ensures your FDA submission is both technically accurate and strategically planned.