NeuroPace, Inc. - Comment

Document ID: FDA-2011-D-0577-0004
Document Type: Public Submission
Agency: Food And Drug Administration
Received Date: November 01 2011, at 12:00 AM Eastern Daylight Time
Date Posted: November 4 2011, at 12:00 AM Eastern Standard Time
Comment Start Date: August 15 2011, at 12:00 AM Eastern Standard Time
Comment Due Date: November 14 2011, at 11:59 PM Eastern Standard Time
Tracking Number: 80f6459f
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This is comment on Notice

Draft Guidance for Industry and Staff; Availability: Factors To Consider When Making Benefit-Risk Determinations in Medical Device Premarket Review

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Re: Docket Number FDA-2011-P-0577 NeuroPace would like to offer comments to the FDA’s: “Draft Guidance for Industry and Food and Drug Administration Staff: Factors to Consider when Making Benefit-Risk Determinations in Medical Device Premarket Review” Comments are provided in the attached file.

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NeuroPace, Inc. CommentsBenefitRiskDetermination

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NeuroPace, Inc. CommentsBenefitRiskDetermination

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Francisco Martinez Murillo - Comment
Public Submission Posted: 09/27/2011 ID: FDA-2011-D-0577-0003