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