FDA Law Blog

JULY 10, 2023

After a firm submits a 510(k) to FDA, FDA will request still more information after a first-pass review. According to the 2 nd Quarter FY2023 MDUFA V Performance Report , FDA issued a request for additional information (AI request) on the first FDA review cycle for 63% to 68% of 510(k)s submitted in FY2018 to FY2022.

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Provider IT Engineering Medical 75

CDOCS

MAY 4, 2021

I diagnosed this case to be complex, requiring extensive bone regeneration, possibly with multiple grafts and informed this patient of the risks, timeline and complexity of his case. The possible complications were communicated so that the patient could make an informed decision and proceed with treatment.

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Patient-Centered Patients Manufacturing Clinic 52

GeriPal

JANUARY 23, 2025

The intervention involved mailing medication-specific brochures to patients before their primary care appointments (click here for the brochure ). Just found that this was a really easy, low budget way of informing people about the medication, about the potential harms, and they were a captive audience in the hospital. Eric 19:51 Yeah.

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Specialization IT Patient-Centered Medical 120

Mesa Family Physician

MARCH 6, 2025

Unlike appointments that address specific illnesses or injuries, preventive care visits focus on screening for potential health issues, assessing your overall wellness, and helping you establish healthy habits before problems develop. Your provider updates this information at each visit to maintain an accurate picture of your health journey.

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Preventive Care Preventative Care Appointment Screening 100

Physician's Weekly

JUNE 23, 2025

The digital age, while offering incredible access to information, has also become an incubator for the spread of partial truths, facts taken out of context, or outright misinformation. Misinformation is defined as false or inaccurate information that is shared without the intent to deceive.

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Community Vaccination Individual Illness 80

Plum Health

OCTOBER 11, 2024

This guide will help you understand the different types of clinics and services they offer, so you can make an informed decision about where to seek medical care. During these regular appointments, doctors conduct various tests and screenings to catch issues early. Conclusion Finding the right clinic doesn't have to be a headache.

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Clinic Primary Care Doctor Primary Care Chronic Condition 52

Doctor On Demand

APRIL 28, 2025

In these cases, an urgent care clinic might be the best option since it offers same-day appointments, extended hours, and immediate treatment. If your symptoms get worse before your appointment, you may need to go to urgent care. No fever or difficulty swallowing Without these red flags, it’s typically safe to wait for an appointment.

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ER Telehealth Primary Care Doctor Appointment 52

Vida Family Medicine

MARCH 28, 2024

There is a lot of information and a lot of marketing out there creating a lot of confusion. Diabetes, cardiovascular disease, and metabolic associated fatty liver disease all have the potential to cause life-altering complications and premature death. I provide information about the risks, side effects, costs, and potential benefits.

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Diabetes Primary Care Physician Medical Patients 52

Vascular Physician

FEBRUARY 14, 2024

How Smoking Affects Your Blood Vessels For nearly a century, healthcare providers have informed people of the negative health effects that come from smoking cigarettes. The list of complications caused by smoking is extensive, including impacting one's blood vessels and cardiovascular health. For this reason, quitting is worth it.

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Complication Appointment IT Education 40

GeriPal

NOVEMBER 21, 2024

Somebody shouts at my front Desk staff because they’re pissed off about their appointment time. I said, you know, I don’t usually start my appointments in laughter. And I think that’s why by the end of the appointment, we were able to go to equally deep places that were pretty dark and pretty heavy together.

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Illness IT Patient-Centered Patients 126

GeriPal

JUNE 15, 2023

Charlotta: Yeah, I think it will be in reducing the need to spend so many hours on documentation and looking through the EHR for information. Five minute appointments. And what we are seeing in our research is that, we’re working on GPT four, is volunteering information that we didn’t ask for. Eric: Please respond.

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IT Patient-Centered Patients Healthcare 100

GeriPal

MARCH 28, 2024

We all, when bombarded with information have to take certain elements of a decision and focus on those; and in the ICU, you can imagine, we’re bombarded with information a lot. We put a couple extra things in place to really try to reschedule appointments, and this was telehealth. It was very difficult. Is that right?

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Consulting Patient-Centered IT Patients 116

GeriPal

JANUARY 25, 2024

It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit. It used to be a much more complicated model. As a nurse, how challenging would it be to do eight hours of training and jump into this complicated world? Eric: How about you, David?

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Patient-Centered IT Illness Patients 123

GeriPal

MARCH 6, 2025

We discuss the principles of harm reduction, social determinants of health, and trauma informed care. By the time he got into us, the tumor grew, he had experienced, he was experiencing significant pain and so trauma, informed care and building a relationship with him was such a big part of the care. On bias and trauma as you.

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Healthcare IT Community Illness 102

GeriPal

JULY 21, 2022

If they’re in a major car crash, they’re going to have more long-term complications probably than a 20-year-old would. When you think about getting your groceries, going to doctor’s appointments, going to religious services, if that’s important to you. I can get you guys that information.

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Family IT Families Diagnosis 102

GeriPal

MARCH 24, 2022

So I do think it often does happen that younger adults appoint a surrogate when they engage in estate planning, for example. And I don’t think necessarily, that appointment needs to be a medicalized process. Susan: I’ll just say, I think that could happen outside of the healthcare setting pretty easily and frequently does.

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Illness IT Healthcare Patient-Centered 73

GeriPal

OCTOBER 12, 2023

And, what if your surgeon openly discussed the expected ‘bad stuff’ of post-operative recovery, instead of rotely reciting a list of possible complications? I think the two spaces it comes out of, one is informed consent, which is this idea that people need to have an understanding of their disease and treatment. Gretchen: Absolutely.

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IT Family Families Patient-Centered 129

Dr. Michael Bazel

OCTOBER 7, 2024

Early detection is crucial to prevent serious complications. Know Your Family History: Inform your doctor of any family history of prostate cancer to personalize your prevention plan. If not properly managed, diabetes can lead to serious complications like kidney disease, nerve damage, and heart problems.

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Mental Health Diabetes Screening Physicals 130

GeriPal

FEBRUARY 16, 2023

Keri: It’s all normal, and it’s all data that can better inform our practice. I recently had this patient in clinic who, for complicated reasons that I won’t go into, our outpatient clinic had to put limits on his frequency of visits with me. Eric: Bored, thinking about- Dani: Feel helpless. Eric: Yeah. Dani: Yeah.

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Patients IT Family Families 110

Family Medicine Initiative

APRIL 10, 2024

Because chronic diseases are largely managed in primary care and are therefore the GPs’ daily business: Patients with multimorbidity account for 78% of GP appointments (based on 100,000 UK patients). GPs improve chronic disease management, which prevents complications. Family medicine today is therefore more important than ever.

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Family Physician Family Families GP 130

Physician's Weekly

JUNE 13, 2025

After one appointment, the woman who was supposed to schedule me for my next one called me “Sweetie.” Patients, Health Advocates See More Risk ,” May 23), have pre-vaccine complications such as multisystem inflammatory syndrome in children been forgotten? There may never be widely accepted guidelines.

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Vaccination Family Families IT 52