The Medical Device registration in the USA is essentially driven by device’s risk class and availability of Predicate Device. A predicate device is a pre-approved device, which is evaluated and approved by the USFDA. Novel medical devices with no predicate devices pre-approved by the USFDA, are automatically designated as Class III high risk devices. The manufacturer can request for a Class I or Class II designation, by opting the De-Novo registration pathway.
Novel medical devices for which the safety and effectiveness can be assured by either the general controls or a combination of general and special controls, but do not have a predicate device, qualify for applying a De Novo classification request. The USFDA would evaluate the risk associated with the device and assign a device class. The devices that are identified either as Class I or Class II under the De-Novo route, can be marketed and used as a predicate device for future devices that are substantially equivalent to this classified device.
The request for De-Novo registration application may be triggered either from the Not Substantially Equivalent (NSE) issued by the US FDA in response to 510(k) application or from non-availability of predicate device, when evaluated by the device manufacturer. However, manufacturers may have to consider a pre-submission meeting with the USFDA, before submitting a De-Novo request.
The application for a De-Novo request shall include:
- Device description,
- Recommended classification
- Justification of why and how general or a combination of general and special controls can assure the safety and efficacy of the device in scope
- Suggested special controls applicable for the device, in case the novel device is recommended to be a Class II device
- Non-clinical data, including, bench performance
- Clinical data (if applicable) to support the safety and effectiveness of the device
- Benefit-risk determination of the device
- Other information such as, sterilization, biocompatibility, cybersecurity assessment, electromagnetic compatibility etc.
- Administrative information
The request shall be prepared, validated and submitted as an E-copy, as per the USFDA requirements. The USFDA charges the MDUFA user fees for evaluation of De-Novo request. The manufacturers, who qualify for the Small Business Determination (SBD) program may obtain Small business Certification, to avail reduced medical device fees.
The USFDA may either accept or reject the request made by the device manufacturer or applicant. The De-Novo applications which successfully demonstrate the safety and effectiveness of a device through either general controls or a combination of general and special controls gets granted by the US FDA. The devices for which the request is granted can be marketed in the USA and used as a predicate device for similar devices in the future and this new device type gets a new classification regulation. The ones which fail to establish such adequacy are declined by the USFDA. The devices for which the request is declined shall apply for Pre-Market Approval (PMA). The USFDA’s timelines for evaluation of De Novo request is 150 review days (excluding the days a request was on hold for an Additional Information request).
MDUFA User Fees:
Small Business Fee*
October 1st, 2020 to September 30th, 2021
*For small businesses with an approved SBD
- End-to-End De-Novo Registration
- Pre-Submission / Q-Submission Meeting Request
- Evaluation and Identification of Applicable Special Controls
- Risk-Benefit Determination
- Compilation of De-Novo Submission Package
- Publishing and E-copy Creation for Pre-Submission and De-Novo Request Application
- Liaising Services