An Overview of the Difference ween a 510(k) and a de novo 510(k)

De novo device is basically a new device which do not have any ‘substantially equivalent’ to legally marketed predicate devices. Therefore, the de novo device is automatically designated as Class III⁽¹⁾ via section 513(f)(1) of the FD&C act regardless of the level of risk the device poses⁽¹⁾.  However, the risk involved with these de novo devices oftentimes has lower risk as in Class III devices. Therefore, a Class III classification with all its requirements is not warranted ⁽¹⁾ and create unnecessary burden for sponsor.

What is ‘substantial equivalence’? When a sponsors file for 510(k), it requires a demonstration of substantial equivalence to another legally US marketed device.

Substantial equivalence means that the new device is at least as safe and effective as the predicate device. It has the same intended use of the predicate device and the same technological characteristics as the predicate device(3).

BUT it does not mean the new and predicate devices must be identical (3).

How does a sponsor and the agency handle a product which is new and no predicate device? It will be handled via de novo 510(K).

An overview of the differences between a 510K and a de novo 510K is tabulated in the table below.

Overview of Differences	510K	De novo 510K
Technology(2)	Old	New
Substantial Equivalence(1,2)	Yes	No substantial equivalent because it involves a new technology
Risk Factor (1,2)	N/A	De novo sometimes has the risk profile of a traditional 510K. Generally, de novo process is for lower risk devices.
Approval Mechanism(2)	Prove of substantial equivalence.	Not based on new technology, but based on risk the device presents. Sometimes, it can be handled via Class II special control or even Class I general control
Submission of 510K(1.2)	Yes	510(k) must be submitted first. Next, FDA will send a letter saying the device is not substantially equivalent (NSE). Then, sponsor can within 30 days to petition for de novo process to reclassify its device out of Class III.
Risk-Benefit Analysis(2)	Not Required	This is critical for the de novo petition. Device can then be classified into Class I or II.
Human Experience like Clinical Investigations(2)	Generally, not require	Must include any available data on clinical investigations.
Reclassification Period(1,2)	N/A	Agency has 60 days to review the de novo request. FDA might ask for additional information and sponsor must response in 30 days, if fail, agency will keep the device in Class III.

 1. ---De Novo Classification Process (Evaluation of Automatic Class III Designation),
    October 3, 2011, US FDA, CDRH.
2.  Swift, A. M. 2006, The “de Novo” 510(k) Process and the Reclassification of Class III
      Devices, RA Focus, pp: 32-34.
3.---Premarket Notification (510k), US Food and Drug Administration website, page last
    updated: 01/03/2014.