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From:
Patient, Consumer, and Public Health Coalition
(Uncensored)
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Coalition comments Regarding the FDA Draft Guidance Recommendations for the Use of Clinical Data in Premarket Notification [510(k)] Submissions
https://patientsandconsumers.org/coalition-comments-regarding-the-fda-draft-guidance-recommendations-for-the-use-of-clinical-data-in-premarket-notification-510k-submissions/?utm_source=rss&utm_medium=rss&utm_campaign=coalition-comments-regarding-the-fda-draft-guidance-recommendations-for-the-use-of-clinical-data-in-premarket-notification-510k-submissions
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In its public comment, members of the Patient, Consumer, Public Health Coalition urged FDA to rely more on scientifically credible types of clinical data for 510(k) to ensure patients’ health and safety.
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