seehafer

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.

Though (very) unevenly distributed

Yet again we see that Steve Jobs’ user interface instincts were right: he hated the idea of apps and fought putting them on the iPhone.

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)

I am a great admirer of Tyler’s but he often does too much thinking and too little feeling, particularly in the context of art.

> 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.

Great to see Dr. Rezai getting his due. One of the pioneers of neuromodulation; he's been involved in deep brain stimulation since the early days.

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.

Same. I’m fact I suspect a large proportion of HN’s audience started around this age.

This evokes the Internet of the 90's, when it was home mostly to misfits, nerds, and outcasts. A simpler time. A happier time.

We’re talking about California here, which is functionally a single-party state, and that party is not the Republican Party.

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.