FDA Near to Closing Books on Grandfathered Medical Devices
Source: MedPage Today
John Grohol’s analysis of the below MedPageToday article:
Original MedPageToday article:
WASHINGTON, April 9 — The FDA is finally closing a loophole that has allowed high-risk medical devices to remain on the market in the absence of clinical test data.
The agency decreed Wednesday that it would require safety and efficacy data from manufacturers of certain medical devices who, thanks to a quirk in previous regulations, never had to prove their safety or efficacy.
The devices fall into 25 categories and include automated external defibrillators, female condoms, and electroconvulsive therapy machines. Their manufacturers have until this August to submit data on these devices.
They may be required to go through the agency’s full premarket approval process as if they were entirely new products.
In 1976, the agency began requiring that new medical devices undergo a rigorous premarket approval process in which manufacturers either had to prove they were safe and effective, or show that they weren’t high-risk and therefore didn’t need such stringent review.
In this context, high-risk means that the device’s failure to function properly could lead to serious or life-threatening complications.
But companies with high-risk products already on the market were allowed to keep selling them, with the understanding that eventually the agency would require them to submit the same type of data needed for newer products.
It took nearly 20 years for the agency to begin following through. In 1994, there were 149 categories of high-risk (known as Class III in FDA parlance) devices remaining on the market from the pre-1976 era without any data submission or approval.
By 2000, the FDA had cut the number down to 82.
It currently stands at 27, and the agency has now set August 7 as the final deadline for all but the last two.
The FDA will review the submitted data and determine whether the devices will need a full premarket review, requiring the company to submit detailed clinical safety or efficacy data.
Alternatively, the FDA can reclassify the devices into lower-risk Class I or II, for which such data are not required.
In the case of electroconvulsive therapy machines, for example, there are eight companies that market the devices, none of which were ever required to undergo premarket approval.
Rather, they all were cleared under the so-called 510(k) process, which automatically okays the devices if it is “substantially equivalent” to an already approved product, called a predicate device.
Since no ECT machine went through the premarket approval process, there is no predicate device. Hence, manufacturers of ECT machines must seek approval for them as if they were new to the market.
Two device types will remain outstanding, including a “topical oxygen chamber for extremities,” said an FDA spokeswoman, Peper Long.
According to Long, since the FDA began its backward look at already-marketed devices, it has required makers of silicone gel breast implants, replacement valves, and IUDs to go through the premarket approval process.
She said one type of device had been pulled from the market as a result of the FDA review, but could not immediately identify it.