FDA's Gottlieb Hints at a Huge Overhaul of Health Tech Regulations

The recently confirmed FDA commissioner plans to make good on his promise of getting out of Silicon Valley's way.


When Apple CEO Tim Cook was asked in 2015 if the forthcoming Apple Watch would feature cutting edge health technology, the answer was a very clear no. Making the Apple Watch more than just a really pricey fitness tracker would require approval from the Food and Drug Administration, and that, in turn, would "hold [Apple] back from innovating."

In a blog post published this week, recently approved FDA Commissioner Scott Gottlieb acknowledged that "ambiguity regarding how FDA will approach a new technology can lead innovators to invest their time and resources in other ventures."

To that end, writes Gottlieb,

FDA will provide guidance to clarify our position on products that contain multiple software functions, where some fall outside the scope of FDA regulation, but others do not. In addition, FDA will provide new guidance on other technologies that, although not addressed in the 21st Century Cures Act, present low enough risks that FDA does not intend to subject them to certain pre-market regulatory requirements. Greater certainty regarding what types of digital health technology is subject to regulation and regarding FDA's compliance policies will not only help foster innovation, but also will help the agency to devote more resources to higher risk priorities.

We don't yet know what the FDA's new guidelines will look like, but the tech industry is likely to get more clarity. Gottlieb wants the new guidelines to be transparent enough that developers can "apply them on their own, without having to seek out, on a case-by-case basis, FDA's position on every individual technological change or iterative software development."

The timing for these reforms couldn't be better. Apple has been hiring medical tech engineers since early last year, and it is allegedly working on a blood glucose monitor for diabetes patients that doesn't require piercing the skin. Verily, meanwhile, is working with Dexcom, which manufactures a continuous glucose monitor that does pierce the skin, to make the device even less obtrusive. (All of Verily's projects look great, actually—and all, I suspect, will require some interaction with the FDA.)

At the cheaper end of the market, we may just get better fitness and health apps for mobile devices. This software generally doesn't require FDA approval, but even device makers aren't sure when they should talk to the agency. In 2015, when he was still at the American Enterprise Institute, Gottlieb told NPR that bringing these apps under the FDA's purview would "create so much uncertainty for product developers that it's going to discourage a lot of investment and it's going to discourage a lot of programmers from getting into this space."

"Hopefully this is a signal that the FDA is waking up to the realities of the Information Age and are willing to let consumers take advantage of the many life-enriching—and potentially even life-saving—technologies that could be at their disposal if not for excessive bureaucratic red tape," says Adam Thierer, a senior fellow at the Mercatus Center's Technology Policy Program.

As soon as this fall, writes Gottlieb, the "FDA will pilot an entirely new approach toward regulating this technology."

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  1. Gottlieb wants the new guidelines to be transparent enough that developers can “apply them on their own, without having to seek out, on a case-by-case basis, FDA’s position on every individual technological change or iterative software development.”

    So evil corporations are not going to have constant government oversight as they try to improve lives while making a profit?

    I’m scared.

    1. Well, Apple is one of the ‘good’ corporations to most leftists. Just don’t pull back the curtain to reveal where and how their iPhone’s are made, of course.

    2. Fucking assholes, making money off of my voluntary procurement of their wares.

      1. How DARE they provide additional desirable services at a premium!

  2. We don’t yet know what the FDA’s new guidelines will look like

    Oh, come on, Mike. They’ll look like this.

    1. My brain hurts.

      1. The FDA is here to help (assuming you qualify for one of our trials located nowhere near you and which will complete sometime in the 23rd century–thanks for your suppport).

        1. The FDA is here to help

          Look sometimes guidance comes in the form of ‘take a left on Main, right on Elm, and it will be on your left’ sometimes is comes as ‘second star to the right and straight on till morning’ and sometimes it comes as a yardstick to the side of your head.

          Just because you don’t like it doesn’t mean you aren’t being helped/guided.

    2. Health is the war of the State.

    3. How is a company to know whether its a good idea to conduct thorough QT studies as part of the development
      of large proteins and monoclonal antibodies unless the FDA tells them its a good idea?

  3. I’m so sick and tired of the right just reacting to the left and having no ideas of its own.

    BTW, uninvasive glucose monitoring has been the medical equivalent to finding the holy grail for just about as long as the latter has been around. Don’t hold your breath.

    1. It would appear ‘status quo’ isn’t good enough for those who are engaged in everlasting revolution. It’s basically the progressive version of a DDoS attack, in that they simply overwhelm the system with bullshit idea’s that are almost entirely poison pills for whatever system they’re attacking.

    2. Actually, Skippy, this article is just describing business as usual for the regulatory state.

      It originates from the 21st Century Cures Act. Section 3060 says:
      “Certain software is exempted from requirements for medical devices, including software that provides medical recommendations and the basis for those recommendations to health care professionals. Software remains subject to regulation as a medical device if: (1) the software acquires, processes, analyzes, or interprets medical information; or (2) the FDA identifies use of the software as reasonably likely to have serious adverse health consequences.”

      So Congress tells the FDA to regulate “medical devices” but says that not all related software should be regulated, and writes a vague set of standards by which to decide which should be regulated and which should not. So the FDA evidently is now getting around to writing those rules.

      This isn’t a bold idea from conservatives. This is how the regulatory state has worked for the past 70+ years. It’s Republicans adopting the premises of Democrats.

      1. But this is just the beginning jeffie. From the original posting and quoted in the article

        In addition, FDA will provide new guidance on other technologies that, although not addressed in the 21st Century Cures Act, present low enough risks that FDA does not intend to subject them to certain pre-market regulatory requirements.

        So your argument appears to be that not regulating is the default of the regulatory state. Makes sense.

      2. Also from the blog posting:

        While the pilot program is still being developed, we are considering whether and how, under current authorities, we can create a third party certification program under which lower risk digital health products could be marketed without FDA premarket review…

        3rd party approval, e.g. UL is such a dated, status quo concept from the left.


          This is Republicans operating within the premises created by Democrats and tinkering around here and there. It’s not a big bold idea. So bully for Gottlieb for writing an FDA rule that might be slightly better than one that a Democrat might have written. But he’s still writing rules under the premise that the FDA *ought* to be regulating medical devices.

          This has happened time and time again:

          The left creates the progressive income tax system, and the right just tinkers with brackets up and down.
          The left creates the FDA, and the right just writes slightly better rules.
          The left creates the Department of Education, and the right just manipulates it to give us things like NCLB.
          The left creates the entitlement state, and the right just tries to turn it into block grants or some such.

          In pretty much every case, the right operates within the framework created by the left. Occasionally they do good things. But the left’s ideas are ultimately still in the driver’s seat.

          Maybe I’m totally wrong on the FDA thing and Congress will step up to seriously deregulate the medical industry. But I am willing to bet that if a vote was held in the Senate tomorrow to abolish the FDA, it would fail 99-1. (I would hope at least Rand Paul would vote for it.)
          The left

          1. the premise that the FDA *ought* to be regulating medical devices.

            That “premise” is a command of the Federal Food, Drug and Cosmetic Act, and has been for the greater part of a century. Nothing the administration can legally do about that.


            “But he’s still writing rules under the premise that the FDA *ought* to be regulating medical devices.”

            No, he’s EXEMPTING items FROM regulation.

            Are you truly this stupid? Removing items from predatory regulation is progress. By your clearly impaired logic literally every libertarian principle is reactionary because it would have to contend with existing law. For that matter, you haven’t brought a single new idea to this thread. You’re simply reacting to me. You could try innovating.

  4. It would be awesome if Gottlieb gave the FDA the overhaul it needs, but i can’t see Trump giving him the nuclear codes.

    1. The FDA under this administration has been my “but Gorsuch.” I’m still cautiously optimistic.

      1. Gottlieb (along with Pai at the FCC) says the right stuff. Gorsuch… hasn’t really done anything yet.

  5. OT. This “news” is five weeks old, but I didn’t see it until today.

    “According to The Hollywood Reporter, Depp has signed on to star in King Of The Jungle, a movie about McAfee Antivirus creator John McAfee. As people who follow the tech world are probably aware, McAfee went a bit?as THR puts it?”Colonel Kurtz-like” when he decided to take all of his antivirus money, abandon civilization, and live in a jungle paradise full of “guns, sex, and madness.””


    1. How can you do a movie about a story that hasn’t had its amazing ending yet?

      1. He becomes president in 2020?

        1. I was thinking more along the lines of a hostage situation involving about 20 strippers, a pallet of plastic-wrapped drug bricks, Richard Simmons, and an elephant, but I see your prediction as about equally likely.

          1. Wait, so McAfee’s the guy who’s basically been keeping Richard Simmons prisoner in his own house for the last three years? Christ, what an asshole.

          2. we call that Tuesday here

      2. How can you do a movie about a story that hasn’t had its amazing ending yet?

        WTH are you talking about? You do a McAfee Movie, a Johnson Movie, and an Austin Petersen movie and cap the whole thing off with a Libertarian Party: Civil War movie.

        Movies with bow-tie endings… phbbbt. Go back to your Nickelodeons!

        1. I don’t want to live in a society where a man who creates a jungle paradise with drugs, sex, and guns is considered “crazy.”

  6. As soon as this fall, writes Gottlieb, the “FDA will pilot an entirely new approach toward regulating this technology.”

    Like, not regulating it?

    I guess considering the status quo, “not regulating it” could be considered an “entirely new approach”.

    1. That’s crazy talk. If the FDA didn’t intervene, every pharmacorp and device manufacturer would spend all its time and money coming up with ways to murder its customer base. It is known.

    2. A bit slow but you’re finally starting to get it.

    3. But they need a good legal excuse not to regulate something. They need to be able to point to something in the FDCA that says Congress will let them lay off something because whatever. Not only that, but if they adopt a new rule countermanding an old regulatory rule, there’s a presumption of validity of the older rule, and they can’t just say they decided it’s no longer needed just because they think deregul’n’s cool; otherwise it’s “arbitrary & capricious” & the reg could be reinstated by court order, as happened with air bags in the 1980s.

      Congress, however, can change their minds any time they want, by new act of Congress. Remember, though, even as unpopular as both air bags & seat belts were 30+ yrs. ago, repeal was never seriously in the cards. And it also looks like the “teaching function of the law” won, in that people do tend much more to wear them now.

      1. What it boils down to is that Congress is allowed to change course based on value judgments, while the administr’n is constrained to changing course only on the basis of factual judgments, and, if they’ve already made a factual judgment, on the basis of change in the facts. Someone sued to get the air bag mandate reinstated, & the issue in court was what facts changed about safety in collisions that would cause them to change the regul’n, & because the TSA or DOT (I forget which) couldn’t show anything other than that philosophy changed about regulation when the Reagan era came, they lost & the busybodies won.

        Similarly, if FDA had some reg on medical devices that they now want to deregulate, the legal issue is, what changed about med’l devices that causes FDA to no longer administer this part of the FFDCA in this way? It’d have to be a change in the nature of the technology itself, not about whether FDA’s previous interpret’n was correct, let alone whether it was a good policy.

  7. By law, I can’t walk into a Teriyaki joint and not see the calorie content of the meal I’m buying. I’m wondering how successful the FDA will really be in unwinding itself from the most petty of regulations.

    1. Looks like there is a market out there for an app that blocks the calorie info from a menu.

      Hey, this could be a totally new thing. An app for lefties to blur out any conservatives they pass on the street and vice versa.

      1. Good idea. Eventually, they will speciate into two different types of Eloi, which us libertarian Morlocks can then hunt.

        1. Except the Cosmorlocks will be too busy fighting the Yokmorlocks to ever move past the hunter-gatherer phase into Eloi husbandry.

      2. There is an app for that. It’s called alcohol.

      3. an app that blocks the calorie info from a menu

        jesus christ, people, take pride in your gustatory accomplishments. Now I’m tempted to head to McDonalds to see how high a score I can rack up on the kiosk myself.

      4. Reminds me of an important aspect of a Black Mirror episode, “White Christmas.” Highly recommended: http://www.imdb.com/title/tt3973198/?ref_=ttep_ep1

  8. Ultimately most of this stuff needs statutory clarif’n and/or relief to get a more stable sol’n to the uncertainty.

    One reform that would help immensely would be to add (yes, sorry) something to the US Code to the effect that, for the purposes of Titles 20, 21, & who-knows-what-else, a use of a product shall not be inferred as “intended” unless…and there are various qualif’ns that could be put here to put more of a presumption on a use’s not being intended by the purveyor of the product w/o some positive statement by the purveyor. As it is now, there’s a tendency by FDA, DEA, EPA, ICE, & I’m sure other fed agencies to rope products into certain regulated (or controlled or prohibited) categories based on evidence from knowledge of how to use such products by consumers (or physicians or exterminators, etc.) that the purveyor intended the product for such use. HyR just highlighted an example where Customs inferred a particular brand of lockable case to be drug paraphernalia on the basis of online product reviews.

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