All Clarivate websites use cookies to improve your online experience. They were placed on your computer when you launched this website. You can change your cookie settings through your browser.

More information on our cookie policy.

BioWorld. Link to homepage.

Clarivate
  • BioWorld
  • BioWorld MedTech
  • BioWorld Asia
  • BioWorld Science
  • Data Snapshots
    • BioWorld
    • BioWorld MedTech
  • Special reports
    • Aging
    • Artificial intelligence
    • Coronavirus
    • IVDs on the rise
    • Top Biopharma Trends of 2021
    • Top Med-tech Trends of 2021
    • Premium reports
      • BioWorld Financings Reports
      • Disease Incidence & Prevalence Summaries

BioWorld. Link to homepage.

  • Sign In
  • Sign Out
  • My Account
Subscribe
BioWorld - Wednesday, August 10, 2022
Home » Blogs » BioWorld MedTech Perspectives » Obscurantism: Just another day in DC

BioWorld MedTech Perspectives
BioWorld MedTech Perspectives RSS FeedRSS

BioWorld MedTech

Obscurantism: Just another day in DC

Jan. 23, 2015
By Mark McCarty
No Comments

If only policy came together this seamlessly...maybe.
If only policy came together this seamlessly ... or is it just as well?

The federal government seems at times determined to make a blogger’s job easier, and recent events do little to dissuade one of that view.

Following are a couple of developments of interest to device makers, but we can’t be sure what’s real and what’s just more smoke and mirrors.

Is corporate tax reform kaput?

As we noted recently, Secretary of Commerce Penny Pritzker said in public that the administration wants revenue-neutral tax reform, but President Obama said little about taxes in the State of the Union address other than that he sees a need to boost taxes on the well-off in order to pay for free junior college and other things.

The President’s silence on the issue doesn’t mean corporate tax reform is DOA, but Pritzker was the first in this administration to say anything favorable toward revenue neutrality. Trust me when I say the GOP will not go for corporate tax reform that is revenue enhancing.

Nothing against Secretary Pritzker, but until I hear it from the horse’s mouth…

Taking the initiative or taking an initiative over?

One model of leadership is said to consist of finding a parade and jumping in front. At first glance, that seems to be the case with the President’s Personalized Medicine Initiative, which entirely ignores the fact that the House of Representatives has been working on just this for quite some time now in the guise of the 21st Century Cures initiative.

There’s another model of leadership that’s more or less prevalent in both the public and private sectors. It’s called, “take the credit for the work of others and pretend the idea was entirely yours.” I hear it’s great for morale and should go a long way toward easing tensions between 1600 Pennsylvania Ave. and Capitol Hill.

New questions of usability?

Just when you think you’ve heard it all, you read another FDA product development guidance. FDA’s draft guidance for “wellness devices,” states that the classification of such an offering may depend on whether the device presents “novel questions of usability.” That’s odd because the guidance seems to suggest at the outset that unless the intended use indicates a moderate degree of risk, these devices are presumed to be class I devices.

So how does a developer document that the wellness device does not present novel questions of usability? I don’t know. Human factors engineering? Studies of the article’s use in real-life settings?

I started my review of this draft guidance thinking it was a way to get some really basic mobile medical apps to market, but this question about novel questions suggests FDA is bound and determined to snare them all in its class II (or higher) regulatory tentacles. Shocking, no?

You must login or register in order to post a comment.

Report Abusive Comment

Popular Stories

  • Free access to BioWorld coronavirus articles

    BioWorld
    The articles in this collection are from BioWorld’s ongoing coverage of the COVID-19 coronavirus pandemic. They are available for free with registration. Note...
  • Today's news in brief

    BioWorld
    BioWorld briefs for Aug. 9, 2022.
  • Today's news in brief

    BioWorld MedTech
    BioWorld MedTech briefs for Aug. 9, 2022.
  • Amvuttra

    Alnylam’s Amvuttra rare disease drug among positive recommendations from Europe’s CHMP

    BioWorld
    Alnylam Pharmaceuticals Inc.’s Amvuttra (vutrisiran), a treatment for the rare disease hereditary transthyretin-mediated amyloidosis, was among medicines...
  • Pig organ cells

    Whole body cellular function recovery in pigs after death

    Science
    A new system for restoring cell function and tissues in mammals after death could expand the availability of organs for transplantation. The research also opens...
black cortellis ad

BioWorld Premium

Enjoy extended coverage for the most complete market view with BioWorld, BioWorld MedTech, and BioWorld Asia in a single, easy to access subscription.

Subscribe
  • BioWorld
    • Today's news
    • Analysis and data insight
    • Clinical
    • Data Snapshots
    • Deals and M&A
    • Financings
    • Newco news
    • Opinion
    • Regulatory
    • Science
  • BioWorld MedTech
    • Today's news
    • Clinical
    • Data Snapshots
    • Deals and M&A
    • Financings
    • Newco news
    • Opinion
    • Regulatory
    • Science
  • BioWorld Asia
    • Today's news
    • Analysis and data insight
    • Australia
    • China
    • Clinical
    • Deals and M&A
    • Financings
    • Newco news
    • Regulatory
    • Science
  • BioWorld Science
    • Archives
    • Today's news
    • Search BioWorld Science
    • About
  • More
    • About
    • Archives
    • Article reprints and permissions
    • Contact us
    • Cookie policy
    • Copyright notice
    • Data methodology
    • Podcasts
    • Privacy policy
    • Share your news with BioWorld
    • Staff
    • Terms of use
Follow Us

Copyright ©2022. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing