Key differences between the 510(k) and De Novo submission for FDA Medical Device Authorization
- SANRUBIO, LLC
- 2 days ago
- 3 min read
Updated: 2 days ago
Understanding the Regulatory Landscape: 510(k) and De Novo Pathways - FDA medical device regulatory authorizations
Bringing a medical device to the U.S. market involves navigating the FDA's complex regulatory framework. Among the most common pathways are the 510(k) Premarket Notification and the De Novo Classification Request. Each serves specific purposes depending on the device's risk level, novelty, and available market comparisons.
510(k) Premarket Notification overview
Device Classification: For Class I and II devices with an existing, legally marketed predicate device.
Purpose: Demonstrate substantial equivalence to a predicate device.
Key Requirements: Performance data, bench testing, and, where applicable, clinical data.
Processing Time: Typically 90 days, subject to submission quality and FDA workload.
Ideal Use Case: Devices with clear predicates and straightforward equivalence claims.
De Novo Classification Request overview
Device Classification: For novel, low- to moderate-risk devices without a predicate.
Purpose: Create a new classification for innovative devices, supported by general and special controls.
Key Requirements: Detailed risk mitigation strategies, safety and performance data, and, in some cases, clinical evidence.
Processing Time: 150–180 days on average, though this may vary.
Ideal Use Case: First-of-its-kind devices or those addressing unmet medical needs.
Key differences between 510(k) and De Novo
A quick look at 510(k):
Classification: For Class I and II devices with a predicate.
Purpose: Demonstrate substantial equivalence to an existing device.
Requirements: Bench and performance testing, with possible clinical data.
Timeframe: Approximately 90 days for review.
When to Choose: Devices with a predicate and a clear equivalence pathway.
A quick look at De Novo:
Classification: For novel, low- to moderate-risk devices without a predicate.
Purpose: Establish a new classification and set regulatory controls.
Requirements: Comprehensive safety and performance data, including risk analysis.
Timeframe: Approximately 150–180 days for review.
When to Choose: Innovative devices without a clear predicate or those introducing new technologies.
When to choose 510(k) vs. De Novo
Opt for 510(k) If:
Your device has a predicate.
The predicate addresses similar indications for use.
You aim for a quicker, more predictable process.
Opt for De Novo If:
Your device lacks a predicate.
Your device presents unique technological characteristics.
You wish to establish a new device classification with long-term regulatory potential.
Tips for manufacturers
Engage with the FDA Early: Initiate a Pre-Submission (Pre-Sub) meeting to clarify expectations, testing plans, and necessary data.
Thorough Submission Preparation: Ensure your application is complete, well-organized, and addresses all FDA requirements.
Strategic Predicate Selection (510(k)): Choose predicates wisely to simplify the equivalence demonstration.
Risk Mitigation Focus (De Novo): Clearly outline how your device mitigates potential risks to justify its safety and efficacy.
Leverage Expert Support: Work with experienced regulatory consultants to streamline the process and avoid costly delays.
Additional considerations
Cost Implications: While De Novo submissions involve higher fees, they can unlock unique market opportunities.
Clinical Data Needs: Anticipate the need for clinical evidence, especially for novel technologies.
Market Trends: Choose the pathway that aligns with your business strategy and market entry goals.
How can we help you
Navigating the complexities of FDA regulatory pathways requires expertise and precision. At SANRUBIO, LLC, we specialize in guiding manufacturers through FDA medical device authorization. Our tailored services include:
Comprehensive regulatory strategy development.
Pre-Submission meeting support.
Full 510(k) and De Novo submission preparation and management.
Ready to bring your medical device to the U.S. market?
CONTACT US for personalized consulting and take the next step in your medical device journey with confidence.
댓글