Sid — I’m at FDA and would like to talk to you about your proposals to make industry more patient friendly. Will reach out to this address unless there’s a better one.
510(k) summaries are always a negotiation between FDA (which wants as much data as possible in them) and manufacturers (which want as little data as possible, as it is priceless competitive intelligence)
> 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.
> 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.
From a submission standpoint, as I write this, FDA seemingly cares more about cybersecurity than your medical device actually demonstrating safety and efficacy within intended use. The time that review teams have to review any given device has stayed the same, but fear-driven, heavy-handed cybersecurity regulations (which must be followed) have been added to the mix.
Prop 13 was an effect, not the cause. The cause was and remains a lack of housing supply. Prop 13 was a knee jerk reaction to skyrocketing property values in the 70s caused by (among other things) policy (largely NEPA and CEQA) that was weaponized to make it ever more difficult to build.
The European Commission is likely going to keep extending out their MDR transition timeline indefinitely. That or allow thousands of devices to get taken off the market.
Had a very similar experience hanging out with him and his equally-brilliant wife Robyn in ATX between 2011-2012. Very approachable guy -- impressively so, given his stature in the industry -- but could be quick with the "what the hell are you talking about?" look.
This change would have certainly increased overall risk so a new 510(k) would have been required if this device was already commercialized.
And had your management not backed down, and tried to push this through as a Letter to File, you'd have been well-within your rights to blow the whistle to FDA. There's not a FDA employee alive that wouldn't go "hold on there chief" to a device change of this magnitude.
Carol Leifer was a writer on the show for many years and the inspiration for Elaine, as she was an ex-girlfriend of Jerry’s and they remained friends after the breakup.
> This company is the next Theranos, and I don't think it's even that bold of a statement to say.
It’s a very bold statement to say when you have no evidence that Boom would or even could ship an airplane that would put people’s lives in danger.
Theranos was not simply a company that made large promises that required leaps in technology and then lied repeatedly about having succeeded in making those leaps. They risked patient safety by providing phony blood test results. It’s important not throw around that epithet unless it’s earned.