This is a silly piece and it misrepresents the space.
For starters, the 510(k) pathway only applies to moderate risk class 2 devices. It's not like every device on the market prior to 1976 was automatically granted 510(k) status which is what this piece implies.
Second, holding medical devices to the same safety standards as drugs is unnecessary. The reason drugs are held to a higher standard is because they present a high risk of acute injury and they are more novel. Most medical devices won't kill you suddenly if they are faulty, and the ones that can are class 3 devices which require a clinical trial component.
Third, the 510(k) pathway exists because the safety risks for device classes are relatively similar whereas for drugs there can be high variability depending on structures. If you design a dental implant that is made of the same material, has a similar design, and has a similar purpose as a pre-existing device which has been shown to be safe, it will generally be safe to assume the new device will also be safe. Most new devices that cannot be shown to be similar to something already on the market are automatically deemed to be high risk and require a trial.
Finally, you can't have your cake and eat it too. Want devices to be as safe as drugs? Apply the same safety standards and watch device costs skyrocket. Then nyt will be back to incorrectly blaming product manufacturers for sky high healthcare costs. The FDA is already in a position where they do not have the funding or manpower to even review all the 510(k)s they get every year. If you make every device submission a premarket approval (highest level of scrutiny + a clinical trial) then devices will never get approved in a timely fashion.
Clarification: upon further digging, it turns out that all devices >= class 2 in production before 1976 were granted 510(k) with the intention of transferring class 3 devices to pma once regulations were developed for them. Most of these devices were transferred by the time I entered the space and make up a small percentage of the total class 3 devices which is why I was not familiar with this. Ignore that part of my previous statement.
It was one of 19 devices that were class 3 (high risk) but granted 510(k) exemptions due to precedent. Ultimately all of these devices were intended to be transitioned to the higher standard pma approval process normally associated with class 3 devices, but were allowed to leverage moderate risk 510(k) pathways typically granted to class 2 devices until pma processes were developed for them. FDA was slow in orchestrating the change, and so this was allowed to continue until these safety concerns manifested, forcing FDA's hand.
I was actually not aware that this had happened as by the time I entered this space almost all of the class 3 devices in question had transitioned to pma. To my knowledge there are very few devices left where this is still the case.
For starters, the 510(k) pathway only applies to moderate risk class 2 devices. It's not like every device on the market prior to 1976 was automatically granted 510(k) status which is what this piece implies.
Second, holding medical devices to the same safety standards as drugs is unnecessary. The reason drugs are held to a higher standard is because they present a high risk of acute injury and they are more novel. Most medical devices won't kill you suddenly if they are faulty, and the ones that can are class 3 devices which require a clinical trial component.
Third, the 510(k) pathway exists because the safety risks for device classes are relatively similar whereas for drugs there can be high variability depending on structures. If you design a dental implant that is made of the same material, has a similar design, and has a similar purpose as a pre-existing device which has been shown to be safe, it will generally be safe to assume the new device will also be safe. Most new devices that cannot be shown to be similar to something already on the market are automatically deemed to be high risk and require a trial.
Finally, you can't have your cake and eat it too. Want devices to be as safe as drugs? Apply the same safety standards and watch device costs skyrocket. Then nyt will be back to incorrectly blaming product manufacturers for sky high healthcare costs. The FDA is already in a position where they do not have the funding or manpower to even review all the 510(k)s they get every year. If you make every device submission a premarket approval (highest level of scrutiny + a clinical trial) then devices will never get approved in a timely fashion.