How did IVC Filters Obtain FDA Approval without Proving they were Safe and Effective?
In that the first IVC Filter device to be approved was the Mobin Uddin IVC Filter under the 510k process, the question arises “How does a device gain FDA approval under 510k when there is no predicate device.” The 510k approval pathway, (process) unlike the Prior Market Approval (PMA) pathway, only requires that the applicant claim that the product they seek approval for is “substantially equivalent” to a device that has already been approved by the FDA. (predicate device)
It is worth mentioning that an applicant for a 510k FDA approval does not have to use their own device as the predicate device, the applicant may use any manufacturers device as the “substantially equivalent” predicate device.
The answers to the question “How did so many IVC Filter devices gain FDA approval without being required to prove they were safe and effective” is found in the Medical Device Act of 1976 and the timing of the Mobin Uddin IVC Filter FDA approval.
Both the Kim Ray Greenfield IVC Filter and the Mobin Uddin IVC Filter were preamendment devices (In Commerce Prior to the Medical Device Act of 1976.) The Mobin Uddin was classified as a Class II and approved 5 months after the Medical Device Act of 1976 went into effect.
The Mobin Uddin IVC Filter was approved in August of 1976 . The Medical Device act of 1976 was passed in May of 1976. (See original 510k Approval for Mobin Uddin IVC Filter)
Due to the fact that the Modin Uddin IVC filter was a preamendment device and the provisions of the act for preamendment devices applied to the FDA approval process for this device, it was not necessary for the Modin Uddin device to prove safety nor efficacy. In that no standard ( predicate) existed for IVC filters, the Mobin Uddin devices became the standard essentially be default.
Because the Mobin Uddin was classified as a Class II (when it arguably should have been a III per the standards set forth in the Medical Device Act of 1976) the device was not required to undergo the PMA process. It appears that the only requirement for Class II preamendment devices was that the manufacture assure the FDA their devices were safe no proof of safety was necessary. Preamendment devices were also not required to prove efficacy. In that the Mobin Uddin was approved 5 months after the Medical Device Act of 1976 took effect, we can assume that the FDA had its hands full with implementing the mandates of the act in 1976 and it was very easy for bad devices to be misclassified and improperly approved during this time period.
Once the Mobin Uddin was Classified as a Class II device and was approved under the 510k process, all other devices save the Cook Birdnest IVC Filter* have been approved under the 510k process.
Essentially, because the FDA arguably made a mistake in Classifying IVC Filters as a Class II Medical Devices and granted 510k approval for the Mobin Uddin IVC Filter, without any testing or proof of safety and efficacy, the IVC Filter as a product made it to market with FDA approval, without having to prove it was safe and effective. IVC Filters that followed used the Mobin Uddin as a “substantially equivalent” predicate device in their 510k applications. As more IVC Filter devices were approved via 510k, those newly approved devices were then used as predicate devices for approval of even more new devices. All of these IVC filters were approved by the FDA without a single device having to demonstrate safety or efficacy. (With the exception of the Birdnest IVC Filter which is a dramatically different design)
The proverbial train came off the track with the approval of the Modin Uddin IVC Filter and all subsequent devices that followed (with the exception of the Birdsnest IVC Filter) also gained approval without having to demonstrate that the devices were safe or effective due to what was obviously a mistake on the part of the FDA in 1976.
In conclusion, the answer to the question “How did IVC Filters obtain FDA Approval” without ever proving they were safe and effective” is simple. It all comes down to timing. We bear the burdens of the mistake of those who came before us. In the case of the “IVC Filter” mistake the burden for many has been death and severe injury.
* The Cook Birdsnest IVC Filter was originally approved via PMA and there were nine supplemental approvals for the Birdsnest Filter through 2006. A modified version of the Birdnest was later approved under the 510k process citing the prior Birdnest design(s) as the predicate device. The Birdsnest IVC Filter has not been used as the predicate device for any other devices 510k applications as it’s design is dramatically different than other devices.