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  • 1.  FDA accreditation

    Posted 02-Aug-2016 13:31

    I recently read an article about series of new health wearables from Philips.   Philips is setting to release a health watch, body analysis scale, a wrist and upper arm blood pressure monitor, and ear thermometer. Each of these will connect to the Philips HealthSuite Health app, which will track a person's bio signals and activity data.

    In the article Philips states "The products have received FDA accreditation, which could make their availability more widespread among doctors and possibly even employers."

    Could someone explain to mean what FDA accreditation means?  It is like a clearance?

     

     

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    Darcy SHEERIN

    Life Sciences for Medical Device R&D Applications Director

    Office: +1 78 1810 3728
    darcy.sheerin@3ds.com

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  • 2.  RE: FDA accreditation

    Posted 02-Aug-2016 23:04

    If I read the same article, Philips didn't say this, the author of the article said it.

    https://www.mdtmag.com/news/2016/08/philips-releasing-new-line-health-wearables

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Durham, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com



  • 3.  RE: FDA accreditation

    Posted 03-Aug-2016 10:15

    I think they were trying to figure out a way to show they have followed FDA regulations, without saying cleared. Using the "watch" as an example, you can find on FDA's web site that Philips had actually listed the device under ProCode "ISD". When you look up that ProCode int he classification database, it is a Class II device, but is 510(k) exempt. Thus, following GMPs etc demonstrates that requirements are met.

    It appears that Philips has had conversations with FDA on this, has FDA agreement on the approach and is following the medical device requirements. However, you can't really say "FDA cleared" for an exempt device.

    g-

    ------------------------------
    Ginger Glaser RAC
    Vice-President, Quality and Regulatory Affairs
    Maplewood MN
    United States



  • 4.  RE: FDA accreditation

    Posted 03-Aug-2016 10:39
    Darcy,

    "FDA accreditation" may have been referred to those devices (FDA 510(k) exempted or 510(k) cleared).

    D