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A Review of CDRH’s Electronic Submission Process

FDA Law Blog

Mullen — As promised in our posts from earlier this summer ( here and here ), we are back to report on our assessment of CDRH’s electronic submission process through its Customer Collaboration Portal (CCP). Say goodbye to your thumb drives and CDs – the CCP electronic submission process couldn’t be easier. It has been seamless.

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The Future Of Vision And Eye Care

The Medical Futurist

How far can you see and hear? When it comes to vision, it’s around 50 miles, talking about hearing, it’s only 1-2 miles at best! What about the smell of the flowers? Without the wind blowing, only 10-20 metres. How about touching or tasting? Well, it depends on your arm’s length, but obviously not further than that. Globally 1.1

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The Healthcare Vision of ChatGPT-4o and Multimodal LLMs

The Medical Futurist

Although this revolution has been brewing for years, the past few months marked a major change , as algorithms finally moved out of the specialized labs and into our daily lives. The future of medicine is undoubtedly inextricably linked to the development of artificial intelligence (AI). ” Patient points to lower abdomen.

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10 Tips to Find the Best Diabetes Doctor for Type 2 Diabetes

Dr. Zaar

Diabetologist: A doctor who specializes in diabetes (sometimes used interchangeably with endocrinologists). Certification shows they’ve completed specialized training and passed rigorous exams. But how do you find the right diabetes specialist in a crowded healthcare landscape?

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Electronic 510(k) Submissions Ahead (FINALLY!)

FDA Law Blog

Mullen — Last month, FDA announced two important steps towards accepting electronic 510(k) submissions. As discussed in an earlier post ( here ), CDRH piloted the eSTAR electronic submission template last year. Being able to submit completely electronically would be a huge benefit in terms of efficiency and timing for applicants.

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Sponsors May Now Request Access to the CCP for Filing of Device Premarket Submissions Electronically

FDA Law Blog

Now, according to the Center’s announcement, anyone may request access to the CCP and begin filing premarket submissions electronically. By Allyson B. Mullen — It is with great excitement that we share CDRH’s announcement that now anyone may submit premarket submissions directly to the Center through the Customer Collaboration Portal (CCP).

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Episode 354: Antiracism in Medicine – Episode 25 – Live from SGIM 2024: Best of Antiracism Research at the Society of General Internal Medicine’s 2024 Annual Meeting

The Clinical Problem Solvers

Michelle Ogunwole, MD, PhD is a health disparities researcher, social epidemiologist and General Internal Medicine physician specializing in the care of women with chronic medical conditions. Clinician Response to Patient Medication Prices Displayed in the Electronic Health Record. During this episode, we hear from Dr. S.