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fix some typos/dedupe meeting minutes
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bewest committed Jan 15, 2015
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Expand Up @@ -7,12 +7,12 @@ Meeting which took place on October 8, 2014.
Summary
-------
* FDA expressed interest in a continuing conversation related to
the NightScout project
* While Medical Device regulations are applicable to the NightScout
the Nightscout project
* While Medical Device regulations are applicable to the Nightscout
project, Medical device requirements are implemented to ensure
patient safety and were written to be flexible to address all
types of medical devices and device manufacturers.
How these regulations can be met was discussed with the agnecy.
How these regulations can be met was discussed with the agency.
* Areas to be discussed – is there one responsible party? -
* How are design controls met during software development?
- How to fulfill post market requirements?
Expand Down Expand Up @@ -115,13 +115,6 @@ recent progress on interoperability from CGM makers.
Subsequent to the meeting, the FDA would like to hear from our
community to help make sure interoperability moves forward.

The group discussed the
FDA’s desire that there be a single responsible party to
ensure that nothing falls through the cracks. The FDA emphasized the
need for one party to take responsibility. For example, change



The group discussed FDA’s desire that there be a single responsible party to
ensure that nothing falls through the cracks. The FDA emphasized the need for
one party to take responsibility. For example, change control to determine when
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