De Novo Program by FDA: What does it mean ? (Part I)

The De Novo program by the FDA is an application process sent by the medical device sponsor to FDA in order to establish the new ‘device type’ along with a classification, regulation and necessary controls with product code. It is also possible the device is eligible to serve as a predicate for new medical devices, where appropriate. The De Novo process can be used for new, novel devices whose type has not previously been classified, but also to reclassify a device from Class III or II into Class II or I.

Section 513, from the Medical Device Amendments, 1976 (under the Federal Food, Drug, and Cosmetic Act) classifies medical devices on a risk-based approach into three Classes and § 513(a)(1)(C) covers the Class III or highest risk device which is unable rely on general and/or special controls.

In 1997, the FD&C Act was modified into the Food and Drug Administration Modernization Act (FDAMA): §513(f)(2) established the De Novo classification process also know as the ‘evaluation of automatic Class III designation’. The process provided regulatory authority to classify devices that were automatically classified into Class III per § 513(f)(1) into Class I or II using criteria of §513(a)(a-b). The sponsor suits a premarket notification (510(k)); if the FDA issues a final 510(k) decision of ‘not substantially equivalent’ due to no predicate, the sponsor submits de novo request and the FDA decides whether to classify device from Class III to Class I or II with new classification and regulation.

In 2012, the FD&C Act was further modified into the Food and Drug Administration Safety and Innovation Act (FDASIA): §513(f)(2) also called the De Novo provision allowed alternative pathway that doesn’t require submission of a 510(k) prior to De Novo request. The timeframe for review set a 120 FDA days in order to streamline and increase the efficiency in the approval process. The sponsor may however still submit 510(k) first, but the intent and decision-king threshold for De Novo eligibility remained unchanged. FDA decides whether to classify the device from Class III to Class I or II.

In 2014, the De Novo Guidance Draft for the classification of medical devices is published and reflects the proposed policy and procedures to implement changes to De Novo program from FDASIA 2012. A new term is used in this Draft Guidance ‘ Direct De Novo’ meaning that 510(k) approval is not mandatory anymore before the De Novo submission.

Two different pathways are still open for Sponsors who want to submit a new medical device. Both pathways contain different regulatory strategies and in depth regulatory knowledge is still import before making such a decision. FDA strongly encourages sponsors to use Pre-Subprogram for potential De Novo. This program an be initiated as soon the device design and intended use are established; also, as soon as sufficient information has been collected regarding safety and effectiveness.

What will happen After De Novo is granted ? (will follow soon in Part II)