Snowflakes in Hell


Firearms Policy and Politics in Pennsylvania

FDA Status of Palm Pistol

author Posted by:Sebastian on date Dec 8th, 2008 | filed Filed under: Guns

This Brady Campaign press release indicates that the FDA has delisted the Palm Pistol (they quote me).  More here form the AP.  In the Palm Pistol Specifications, they have a statement listed:

On December 2, 2008, we were registered as a Medical Device Establishment and the Palm Pistol was listed in the FDA Unified Registration Listing System (FURLS). Based upon agency information, correspondence and verbal instructions, we were led to believe the Palm Pistol was classified as a “device,” were given specific listing instructions, assigned Product Code ILT corresponding with “Recreational Adapter” and identification of the device as a “Daily Activity Assist Device” in accordance with 21 CFR 890.5050, and accordingly informed we had authority to begin marketing it as such a “device.” At no time did we claim the device was “approved” by the FDA, as erroneously reported in the press. We did make every effort to correct this when extended the courtesy of an inquiry.

Constitution Arms claims they still plan on producing the Palm Pistol, and are considering challenging the cancellation of the registration.

UPDATE: More here

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tag7 Responses to “FDA Status of Palm Pistol”

  1. acosenza2 Said,
    December 9th, 2008 at 12:22 am

    Now that is freaking sweet. I aspire to get under the skin of the Brady Campaign so much that they put me in their press releases. You rock.

  2. Sebastian Said,
    December 9th, 2008 at 12:29 am

    I think it wasn’t so much that I got under their skin, as it was they saw an opportunity to use what was written to play up how we crazy gun nuts are thinking… trying to put one over on old Uncle Sam, rather than legitimately trying to help disabled people.

    Of course, that was my reaction, not Matt Carmel’s.

  3. Mikeb302000 Said,
    December 9th, 2008 at 7:55 am

    I wrote about this story today, asking the question how many people do you think have had to curtail or eliminate their gun use due to arthritis?

    While we’re talking about it, what about poor eye sight and senility? Do you worry about those?

  4. SayUncle » Palm Pistol Update Said,
    December 9th, 2008 at 8:39 am

    [...] really a medical device. Translation: Ok, one of our bureaucrats fell asleep at his desk [...]

  5. AntiCitizenOne Said,
    December 9th, 2008 at 8:47 am

    Mike…I’m pretty sure they already took that into consideration…

  6. SayUncle Said,
    December 9th, 2008 at 8:50 am

    In other news, brady reduced to quoting blogs in addition to debating college kids. heh.

  7. Palm Pistol not a medical device says FDA | The Firearm Blog Said,
    December 9th, 2008 at 11:09 pm

    [...] James and Sebastian both report that the FDA have declared that the Palm Pistol is not a medical device. [...]