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.

Classification of Medical Devices Per FDA

The classification of medical devices is basically based very much on risk. Per FDA, It is generally classified into Class I, II and III where Class III has the highest risk and warrants more control and testing like clinical trials in certain cases.  Class II and Class III need 510K and PMA submission respectively to be approved for marketing.

Class III has the highest risk and FDA requires more manufacturing control, risk management and clinical trials. FDA also spends more scrutiny on this class of devices.  This class requires a lot more financial resources and time to deal with. The medical device company requires to file a PMA and obtain approval before marketing.

Class II and I do not require a lot of resources as for Class III and therefore, the money can be spend on innovation rather than spending them on clinical trials. Clinical trial can run in the millions of dollars and at least will take 2 years. Class II 510K approval also much shorter about 90 days compared to 180 days for a PMA.

Overview of the differences between a PMA and a 510(k) FDA submission is summarized in the table below:

Differences	510K Submission	PMA Submission
Class of Device	Generally for Class II and pre-amendment Class III(2).	Generally for Class III(1).
Predicate Device to demonstrate substantial equivalence	Yes.	Yes.
Clinical Study	Generally A Clinical Trial is not required.	The requirement of clinical study which might take 1 – 2 years.
Review Time	̴ 90 days. But, in reality, it is usually takes longer than 90 days.	An average of 1 year.
Application Fee for FY2013(October 1, 2012 through September 30, 2013)	Standard Fee is $4960 and fee for small business with ≤$100 million in gross receipts or sales is $2480(3).	Standard Fee is $280K. Fee for small business is $62K(3).

 

1. --- Premarket Approval (PMA), FDA website, www.fda.gov, Updated as of 01/24/2012.

2. --- 21 CFR 58 Good Laboratory Practice For Nonclinical Laboratory, CFR 21, Volume 1,
       April 1, 2012.

3. ---Premarket Notification 510(k) Review Fees, FDA websites, www.fda.gov, dated
       09/28/2012.

Have any question about medical device regulation, email me at kclowblog@gmail.com

                                  Below is a picture of Magnetic Resonance Imaging

 

 

 

 

 

 

The Definition of Medical Device

Medical Device Regulation

First Post: The Definition of Medical Device. May 24 2014

This blog is entirely dedicated to medical devices and their related regulations and quality systems. Medical devices are regulated by various agencies all over the world. For example, in the US, the Food and Drug Administration (FDA) has the power and authority to regulate medical devices manufactured and sold in the United States. This blog will focus mainly on US. However, this blog also talk about other countries’ regulations like Canada, European Union, Australia, China, Japan, Korea, some South American countries. 

I will try to use literature, article and publication to substantiate each statement if possible. Afterall, this blog is about regulations and guidelines and must be substantiated with facts and data.

What is Medical Device?

Per FDA, A medical device is "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is (1):

·        recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,

·        intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or

·        intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes." (1)

 

(1)---What is Medical Device? USFDA website, www.fda.gov, page last updated: 04/22/2014

 About myself: I am KC Low and home based in San Francisco, CA. I had been working as a consultant and manager in the biopharmaceutical and medical device industries for the past 25 years and love to use this blog to further improve my knowledge on medical device regulation and quality system. That is why I am doing this blog.  I had degrees in mathematics, biochemistry, business administration, chemistry and regulatory affairs. I hold 10 US patents on biopolymers.

Disclaimer: Although the author had exhaustively researched all sources to ensure the accuracy and completeness of the information contained in this blog, but no warranty and fitness is implied. I assumed no responsibility and implied warranty of any kind for errors, inaccuracies, omission, or any inconsistency herein. No liability is assumed for incidental or consequential damages in connection with the use of the information contained herein. Readers should always use their own judgment and review all related regulatory guidelines. Guidelines can change over time.