FDA Law Blog

OCTOBER 24, 2023

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.

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Medical Electronics Provider Screening 52

FDA Law Blog

SEPTEMBER 17, 2023

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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Screening Transportation Provider Electronics 59

Annals of Family Medicine

NOVEMBER 20, 2024

The Centers for Disease Control and Prevention recommends discussing family planning and preconception counseling at the domestic medical exam (DME), yet there is little guidance on specific counseling needs in this population. Population Studied Inclusion criteria were ages 16-45 with a DME performed between 2018 and 2023.

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Family Medicine DO Complication Families 130

Medical Xpress

JUNE 16, 2025

But experts say the risks can be lowered through heart screenings, close monitoring and giving magnesium before and during treatment, The Times added in its report. The information you enter will appear in your e-mail message and is not retained by Medical Xpress in any form. Ibogaine can be dangerous for people with heart problems.

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Mental Health IT Medical Specialization 52

Annals of Family Medicine

NOVEMBER 20, 2024

Annual low-dose computed tomography (LDCT) for lung cancer screening (LCS) has been proven to reduce mortality. Despite this, screening rates among eligible individuals remain low. Objective: This study aims to evaluate screening rates and factors influencing LCS in a large healthcare system in Southeast Michigan.

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Screening Insurance Electronics Healthcare 130

Medical Xpress

JUNE 8, 2025

The information you enter will appear in your e-mail message and is not retained by Medical Xpress in any form. Learn more Your name Note Your email address is used only to let the recipient know who sent the email. Neither your address nor the recipients address will be used for any other purpose.

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IT Management Vaccination Medical 53

GeriPal

APRIL 6, 2023

A friend of GeriPal, and prior guest, Guy Micco commented today that we need an RCT for chaplaincy is like the idea that the humanities need to justify their value in medical training: “It’s like being told to measure the taste of orange juice with a ruler.” It is a screening? I guess FICA is not as cool as SKY. Is it an assessment?

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IT Patient-Centered Families Family 99

PEMBlog

MARCH 27, 2024

She aims to become a physician-scientist in pediatrics and medical genetics, engaging in bench-to-bedside research that utilizes multi-omics-based approaches to provide a molecular diagnosis and support personalized care for individuals with suspected rare genetic diseases and their families. Updated 2023 Jul 17]. No, I’m not.

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Consulting Individual Families Family 59

GeriPal

AUGUST 15, 2024

We discuss: What is considered a hate incident, how is it tracked, what do we know about changes over time The wider impact of Anti-Asian hate on older Asians, who are afraid to go out, leading to anxiety, social isolation, loneliness, decreased exercise, missed appointments and medications. question used to screen for domestic violence.

Mental Health 116

Mental Health Community IT Screening 116

GeriPal

JULY 13, 2023

Randy died February 26, 2023. So sharing one electronic health record, but three separate hospitals within them. So somebody had to write something down in the medical record that talked about goals of care, and there was no template, there was no form that you filled out for this. Erin: Correct. Eric: Okay. Alex: Yeah.

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Patient-Centered IT Patients Hospital 84

Medical Xpress

JUNE 8, 2025

The research, published this week in Safety Science , collected data from 562 recreational surfers from 2020 to 2023. Researchers found that for every 100 surfs, respondents on average gave beachgoers safety advice 11.6 times, first aid 0.4 times and assistance in the water 1.1 With more than 6.3

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Provider Community Medical Diabetes 53

GeriPal

JULY 20, 2023

See the AAHPM Legislative Action Center [link] Write to the DEA, with guidance from AAHPM’s comments to the DEA March 2023. Alex: We are delighted to welcome Joe Rotella, who’s the Chief Medical Officer of the American Academy of Hospice and Palliative Medicine. So now that the emergency response has ended, what’s to be done?

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Telemedicine Telehealth Patient-Centered Board-Certified 73