5 ms·

The site is a little misleading, saying "Several of these devices even led to patient injuries including bleeding, organ puncture, and even cobalt poisoning." T

The site is a little misleading, saying "Several of these devices even led to patient injuries including bleeding, organ puncture, and even cobalt poisoning." The majority of documentation in the 510k process is to mitigate harms to the patient. The catch phrase they use is "safety and efficacy". FDA doesn't really care if your device works as well / better / etc. The market will decide that. FDA cares that you don't injure people more than necessary / more than the predicate device does. (If that sounds strange, consider say a biopsy needle.) The reason 510k is so popular is that introducing a completley new device is incredibly costly typically requriing a PMA (premarket authorization) requiring clinical trial data. If I'm making a new ultrasound machine I don't need to show that ultrasound works -- that's known. I need to show it works as well as one expectes an ultrasound to work, without danger to the patient. Same as if I'm releasing an updated version, re-trialing that doesn't make sense. Honestly a lot of the documentation requirements are absurd -- you'd think "why would anyone do something so badly we need to document that we didn't do that"... but sadly most rules exist becuase of corners that were cut in the past...

thaumasiotes 3y ago
> The catch phrase they use is "safety and efficacy". FDA doesn't really care if your device works as well / better / etc. The market will decide that. FDA cares that you don't injure people more than necessary / more than the predicate device does. That's just safety. > FDA doesn't really care if your device works as well / better / etc. This is the "efficacy" part of "safety and efficacy".
- seehafer 3y ago
  > This is the "efficacy" part of "safety and efficacy". Yes. FDA 100% cares if your device works as well. "Works as well as the predicate" is the foundation of the substantial equivalence paradigm that underlies the 510(k) process. Better is a different story. Legally, they _can't_ care (in a 510(k) anyway), if it works better or not.
  - wcedmisten 3y ago
    Hi, author here! I think my main concern with this process is that the predicate itself might never have gone through clinical trials. So even if the new device works as well as the predicate, that predicate might be equivalent to a whole chain of devices that have never gone through clinical trials. This might be fine if the device is low risk, but the 510(k) process has a history of clearing devices that have resulted in patient deaths. Of course it's a balance between too much red tape and having unsafe devices, I was just personally surprised at where the FDA draws the line today.
    - MichaelZuo 3y ago
      Did you thoroughly read through the linked sources? Because in source number 5, it mentions that some fraction of Class III submissions are cleared through the 510(k) process and not exclusively through the PMA process. > In 2007, Congress asked the Government Accountability Office (GAO) to review the 510(k) process. The resulting 2009 GAO report described the 510(k) process as less stringent, faster, and less expensive than the PMA process and concluded that 66% of Class III submissions cleared through the 510(k) process in recent years were “implantable, life sustaining, or of significant risk,”
      - seehafer 3y ago
        > Because in source number 5, it mentions that some fraction of Class III submissions are cleared through the 510(k) process and not exclusively through the PMA process. Yes, these are what are known as "pre-amendment" devices, referring to those types of devices that were legally marketed in the US prior to the 1976 amendment to the FD&C Act that gave FDA power to regulate medical devices. FDA was given power to require these devices require PMAs via rulemaking, and has been slowly (far too slowly, in the views of many) closing this loophole.
        MichaelZuo 3y ago
        I'm pretty sure the GAO report is largely referring to Class III devices approved after 1976 in this section... under less restrictive rules of some kind.

thaumasiotes 3y ago

> The catch phrase they use is "safety and efficacy". FDA doesn't really care if your device works as well / better / etc. The market will decide that. FDA cares that you don't injure people more than necessary / more than the predicate device does. That's just safety. > FDA doesn't really care if your device works as well / better / etc. This is the "efficacy" part of "safety and efficacy".

seehafer 3y ago
> This is the "efficacy" part of "safety and efficacy". Yes. FDA 100% cares if your device works as well. "Works as well as the predicate" is the foundation of the substantial equivalence paradigm that underlies the 510(k) process. Better is a different story. Legally, they _can't_ care (in a 510(k) anyway), if it works better or not.
- wcedmisten 3y ago
  Hi, author here! I think my main concern with this process is that the predicate itself might never have gone through clinical trials. So even if the new device works as well as the predicate, that predicate might be equivalent to a whole chain of devices that have never gone through clinical trials. This might be fine if the device is low risk, but the 510(k) process has a history of clearing devices that have resulted in patient deaths. Of course it's a balance between too much red tape and having unsafe devices, I was just personally surprised at where the FDA draws the line today.
  - MichaelZuo 3y ago
    Did you thoroughly read through the linked sources? Because in source number 5, it mentions that some fraction of Class III submissions are cleared through the 510(k) process and not exclusively through the PMA process. > In 2007, Congress asked the Government Accountability Office (GAO) to review the 510(k) process. The resulting 2009 GAO report described the 510(k) process as less stringent, faster, and less expensive than the PMA process and concluded that 66% of Class III submissions cleared through the 510(k) process in recent years were “implantable, life sustaining, or of significant risk,”
    - seehafer 3y ago
      > Because in source number 5, it mentions that some fraction of Class III submissions are cleared through the 510(k) process and not exclusively through the PMA process. Yes, these are what are known as "pre-amendment" devices, referring to those types of devices that were legally marketed in the US prior to the 1976 amendment to the FD&C Act that gave FDA power to regulate medical devices. FDA was given power to require these devices require PMAs via rulemaking, and has been slowly (far too slowly, in the views of many) closing this loophole.
      - MichaelZuo 3y ago
        I'm pretty sure the GAO report is largely referring to Class III devices approved after 1976 in this section... under less restrictive rules of some kind.