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Maryland's Primary Care Program: incremental progress or breakthrough?

The Health Policy Exchange

Health Policy Fellowship three years ago, though I still enjoy working alongside these talented family physicians in clinic, such as Dr. Brian Antono, who recently blogged about his fellowship experiences for Harvard Medical School's Center for Primary Care.

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Electronic Submission Template for Medical Device 510(k) Submissions

FDA Law Blog

The development of an electronic submission template for 510(k) submissions is significant in that: eSTAR submissions are not expected to go through the refuse to accept (RTA) process. Exemptions from the electronic submission requirements apply to interactive review responses and some amendments (e.g., add-to-files).

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Hormonal Therapy Online in Canada | Top Answer Questions

Dr. Zaar

In this blog, we’ll answer the most common questions and explain why more people are choosing online hormonal therapy services across Canada. You will get hold of prescriptions electronically, and And observe-up visits manifest thru video or smartphone calls. What Is Hormonal Therapy? Is Online Hormonal Therapy Safe?

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The Rise of eSTAR for Medical Device De Novo Submissions

FDA Law Blog

Mullen — As of October 1, 2023, all 510(k) submissions, unless exempted, must be submitted to FDA using the electronic Submission Template And Resource ( eSTAR ). Currently, eSTAR is voluntary for medical device De Novo submissions, but FDA has initiated the process of requiring De Novos to be submitted using eSTAR.

Medical 52
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New Draft Guidance Provides Detailed (and Burdensome) Recommendations for Chemical Assessments to Support Medical Device Biocompatibility

FDA Law Blog

Chemical characterization identifies and quantifies chemicals that may be released from the medical device, while a toxicological risk analysis (TRA) evaluates the risks to the patient associated with the chemicals identified. KP Medical Device Consulting LLC

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Logistics Unwrapped: A Roadmap to Successful FDA Meetings in In-Person and Hybrid Formats

FDA Law Blog

By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — Over the last three and a half years, meetings with FDA were conducted virtually. If you are driving, stop at the vehicle screening facility and inform security that you are attending a meeting. Getting to Building 66 Most CDRH meetings occur in Building 66.

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11 device policy essentials to keep your practice secure

Physician's Practice

Reynolds Fact checked by Chris Mazzolini Blog Article These essential strategies will enable your practice to safeguard digital assets and ensure compliance. Even innocuous habits— scrolling social media at the nurses’ station —can expose screens to wandering eyes or distract staff from patient care.