Difference Between 510(k) and PMA

Should a medical device manufacturer has a class III device and it has to file for a Premarket Approval (PMA). PMA is basically a FDA process of scientific and regulatory review to evaluate the safety and effectiveness of the Class III medical devices. And PMA is the most stringent device marketing application required by FDA because of its inherent risk and safety of the device. FDA will approve a PMA if the sponsor demonstrated sufficient and valid scientific evidence to assure the device is safe and effective for its intended use or uses.

Examples of Class III medical devices are implantable pacemaker, pulse generator, HIV diagnostic test, automated external defibrillators (AED) and spinal cord stimulator.

Example of Automated External Defibrillators (AED) is shown below:

                                         Courtesy of www.heartstart.com

Several important differences between PMA and 510(k) submission are the cost, time and the requirement of clinical trial data. Since PMA has a higher risk and warrant the most stringent scrutiny⁽¹⁾ from the agency like risk management and manufacturing control.

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.