Master the 510(k) Pathway with ASCA Precision
Reduce FDA review cycles and eliminate technical uncertainty. We provide the GLP-compliant data and strategic expertise needed for successful 510(k), De Novo, and PMA submissions.
Specialized 510(k) Support
A 510(k) submission is only as strong as the data supporting it. The FDA’s scrutiny of biocompatibility (under the 2023 guidance) is at an all-time high. At EBI, we don’t just perform tests; we build the biological safety narrative for your submission.
- Predicate Device Analysis: We help identify and justify the most suitable predicate device to streamline your „Substantial Equivalence” argument.
- Gap Analysis for Legacy Data: If you have existing data, we assess it against current FDA-recognized consensus standards to prevent „Refuse to Accept” (RTA) notifications.
- Submission Documentation: We author the complete Biological Risk Assessment (BRA) tailored specifically to the formatting and scientific expectations of FDA reviewers.
The ASCA Advantage: Faster, Predictable Reviews
EBI is proud to participate in the FDA ASCA (Accreditation Scheme for Conformity Assessment) program. This program is a game-changer for medical device manufacturers.
What ASCA means for your company:
- Streamlined Review: When EBI submits testing results under the ASCA program, the FDA relies on our accreditation, leading to fewer questions and a more efficient review process.
- Reduced Deficiencies: ASCA-compliant reports follow a standardized format that FDA reviewers know and trust, significantly reducing the risk of Additional Information (AI) requests.
- Global Recognition: By using an ASCA-accredited approach, you demonstrate a commitment to the highest international quality standards.
Our FDA Consulting Services
1. GLP-Compliant Biocompatibility (21 CFR Part 58)
The FDA strictly requires that all non-clinical laboratory studies be conducted under Good Laboratory Practice (GLP).
- All EBI studies are performed in our in-house GLP-certified labs.
- Full data traceability and rigorous Quality Assurance (QA) oversight for every report.
2. Chemical Characterization & Toxicological Risk Assessment
The FDA frequently requests chemical characterization (ISO 10993-18) to support or waive certain in-vivo tests.
- Analytical Chemistry: Expert E&L (Extractables & Leachables) studies designed to meet FDA’s rigorous detection limits.
- Toxicology: Expert assessments of chemical constituents by our toxicologists, ensuring safety margins meet US thresholds.
3. Pre-Submission (Q-Sub) Consulting
We represent your interests during formal Q-Submission meetings.
- Developing the testing strategy to get FDA „buy-in” before you spend a dollar on full-scale testing.
- Drafting formal responses to FDA’s technical questions.
Why Major Manufacturers Trust EBI for the US Market
| The Challenge | The EBI Solution |
|---|---|
| FDA "Refuse to Accept" (RTA) | Our reports are formatted to meet 510(k) checklists perfectly. |
| Long Review Times | ASCA program participation speeds up the biocompatibility review. |
| Data Integrity Concerns | 100% in-house GLP-certified labs; no subcontracting. |
| Complex Toxicology | Expert-led Toxicological Risk Assessments included. |
Who We Serve
- QA/RA Managers: Who need reliable, audit-ready data for their 510(k) filings.
- R&D Directors: Looking to de-risk material selection through the ASCA lens.
- CEOs of Start-ups: Who need a partner to handle the entire FDA regulatory roadmap from A to Z.
How We Work
Discovery & Insight
We begin with an in-depth consultation to understand your needs, challenges, and objectives. This helps us define the right strategy and scientific approach for your project.
Design & Development
Our experts translate your vision into actionable plans — combining innovative research, data, and technology to build precise and reliable solutions.
Delivery & Support
We implement the solution with full transparency and ongoing communication. After delivery, we stay involved — supporting you with optimization, updates, and future improvements.
Frequently Asked Questions (FAQ)
Is a 510(k) required for all medical devices in the US?
Not all, but most Class II devices require a 510(k) to demonstrate substantial equivalence to a legally marketed predicate. We can help you determine your device’s specific classification.
Why should I choose an ASCA-accredited lab?
Choosing an ASCA-accredited lab like EBI provides the FDA with pre-market confidence in your testing results, which translates to a smoother, faster, and more predictable path to market clearance.
Does EBI support De Novo or PMA submissions?
Yes. While 510(k) is the most common, our GLP-compliant data is the gold standard required for more complex De Novo and PMA (Class III) submissions as well.
Is a 510(k) required for all medical devices in the US?
Not all, but most Class II devices require a 510(k) to demonstrate substantial equivalence to a legally marketed predicate. We can help you determine your device’s specific classification.
Why should I choose an ASCA-accredited lab?
Choosing an ASCA-accredited lab like EBI provides the FDA with pre-market confidence in your testing results, which translates to a smoother, faster, and more predictable path to market clearance.
Does EBI support De Novo or PMA submissions?
Yes. While 510(k) is the most common, our GLP-compliant data is the gold standard required for more complex De Novo and PMA (Class III) submissions as well.
Contact with us
We’re open to collaboration and research partnerships. Fill out the form — our team will respond as soon as possible.
Location:
Europejski Instytut Biomedyczny sp. z o.o.
ul. Bartycka 63A lok. 6, 00-716 Warszawa
Mail:
contact@ebi.bio
Phone:
+48 22 780 06 32
Get in touch
