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FDA Hosts Webinar for Stage 1 Requirements under LDT Final Rule

FDA Law Blog

The webinar largely consisted of summarizing the general requirements under Parts 803, 806 and 820.198, which we do not reproduce here ( but see another of our prior blog posts discussing these requirements and their applicable to LDTs in greater detail; you can also find FDA’s slides from the webinar here ). By Steven J.

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ICU telemedicine programs bring essential critical care to community hospitals

Sound Physicians

Increasingly a valuable option for rural hospitals, tele-ICU provides access to higher acuity care and support to emergency and hospital medicine clinicians who are called to the ICU. Posted in Critical Care Share Article Subscribe to the Sound Physicians Blog A trusted source for todays healthcare needs. All rights reserved.

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CDRH Seeks Public Comment on How to Increase Patient Access to At-Home Use Medical Technologies

FDA Law Blog

enable individuals to have virtual consultations with healthcare providers through video calls or online platforms), at-home diagnostics (e.g., enable individuals to have virtual consultations with healthcare providers through video calls or online platforms), at-home diagnostics (e.g., telemedicine and telehealth solutions (e.g.,

Medical 45
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Lead, follow or get out of the way

Physician's Practice

For example, practices have adopted electronic medical records (EMR) systems only to find that productivity in the practice ground to a halt. Successful practices have found ways to work around the loss of productivity and ultimately made Electronic Medical Records (EMRs) work effectively in their practices. Make an informed decision.

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This Thanksgiving, Be Thankful for Family and Food(borne Illness Prevention)

FDA Law Blog

Entities covered under the final rule must maintain and provide to their supply chain partners certain Key Data Elements (KDEs) for Critical Tracking Events (CTEs) throughout the supply chain. FDA will hold a webinar to provide an in-depth overview of the final rule and Q&A on Dec. 7, 2022 at 1 p.m.