USA Market
De Novo Classification Consulting
Medical Device
IVD
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What is De Novo Classification Consulting?
De Novo Classification is a regulatory pathway for medical devices that lack a legally marketed predicate device. It allows novel devices (Class I or Class II) to gain market authorization through the US Food and Drug Administration (FDA). Unlike the 510(k) pathway, which relies on substantial equivalence, De Novo Reviews focus on safety and effectiveness for innovative devices without existing predicates.
Why is De Novo Classification Consulting important?
De Novo Classification Consulting is crucial for medical device manufacturers because it provides a regulatory pathway for novel devices that do not have a predicate device, allowing them to enter the U.S. market.
Process Flow for De Novo Classification Consulting
Initial Assessment
Regulatory Research
Preliminary Data Assessment
Strategy Development
Data Collection and Preparation
Submission to FDA
FDA Review
De-Novo Decision
Post Decision Activities
Regulatory Liaison
Documentation and Records
How can we help in De Novo Classification Consulting?
The CliniExperts’ professionals will:
Streamline the regulatory process, potentially reducing time to market and development costs compared to the PMA process.
Ensures that manufacturers present a strong case to the FDA, increasing the likelihood of obtaining the desired classification.
Assists in addressing regulatory challenges and navigating the complex regulatory framework, which can be daunting for manufacturers unfamiliar with the De Novo process.
Helps manufacturers maintain compliance with FDA regulations, avoiding regulatory setbacks and delays.
Regulatory requirements for De Novo Classification Consulting
Documents
De Novo classification submissions typically include a range of documents, such as:
- Detailed device description and intended use
- Data on device safety and effectiveness
- Proposed labeling and instructions for use
- Information on the manufacturing process and quality control
- Risk assessments and mitigation strategies
- Any other relevant documentation to support the classification request
Timeline
De Novo classification can take several months to over a year, depending on the complexity of the device and the FDA’s review timeline.
Regulatory Body
The regulatory body involved in the De Novo classification process is the U.S. Food and Drug Administration (FDA).
Fees
The fee varies, starting at $33,116 for small businesses and going up to $132,464 for larger ones.
Validity
The classification decision remains valid as long as the device continues to meet the criteria and is in compliance with the regulatory requirements.
