BCM EPR proposed work effort

[carl mattocks <carlmattocks@gmail.com>]

Now that the FDA has issued a regulatory statement on classification of Medical systems , please consider if it is now time to define a  BCM EPR work effort for this space

FDA's examination of modern medical device networks and computer infrastructures, informs this reclassification of a category of postamendment computer and software devices that can be regulated under a single classification. This medical device has been named a “Medical Device Data System” or “MDDS.” Because an MDDS does not provide new or unique algorithms or functions, FDA has determined that applying general controls, such as the Quality System regulation (QS regulation or QS requirements) (part 820 (21 CFR part 820)), to the design and development of these devices will provide sufficient regulatory control to mitigate any associated risks. Accordingly, FDA is classifying the MDDS into class I.

https://www.federalregister.gov/articles/2011/02/15/2011-3321/medical-devices-medical-device-data-systems

please comment ..

thanks

Carl Mattocks
--
CEO CheckMi
Chair OASIS BCM Tech Committee
President BTUSAR Dive Team
Producer Shore Adventure
Cell (usa) (732) 497-CARL {2275}
CarlMattocks@CheckMi.com
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