FDA Law Blog

FEBRUARY 22, 2023

In 2016 , the agency issued its definitive HF guidance, guide manufacturers through human factors engineering processes during the development of new medical devices, focusing specifically on the user interface. For example, if a critical task is introduced or impacted does that trigger the need for a new 510(k)? By Jeffrey K.

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Manufacturing Engineering Medical IT 64

FDA Law Blog

NOVEMBER 20, 2024

Since the first issuance of FDA’s guidance Use of International Standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process” in 2016, sponsors submitting premarket submissions to FDA have had the option of using these techniques to evaluate certain biocompatibility endpoints.

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Provider Medical Manufacturing Consulting 59

FDA Law Blog

JUNE 23, 2021

For 6 years, I served as a patient liaison within FDA in what was then called the Office of Special Health Issues. Over the years, this function expanded to cancer (renamed the Office of AIDS and Special Health Issues) and, ultimately, all serious and life-threatening diseases (dropping the AIDS nomenclature).

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Patients Patient-Centered Clinic IT 52

The Motivated MD

SEPTEMBER 19, 2024

A study by Johns Hopkins in 2016 found that medical errors may potentially be the third leading cause of death nationwide. I am not liable for any loss of profit or any other commercial damages, including but not limited to special, incidental, consequential, or other damages. So yes, humans make mistakes.

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Finance Individual Education Healthcare Professional 52

Physician's Weekly

JUNE 17, 2025

The retrospective study included 762 patients with unstable keratoconus diagnosed at Mass Eye and Ear between January 2016 and October 2022. Kanu, MD , and colleagues. Odds ratios for CXL were 0.34 with male sex, 0.37 with public health insurance, and 0.39 with Black race.

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Insurance Patients Specialization Diagnose 52

GeriPal

JULY 28, 2022

Alex: And we are also delighted to welcome Areej El-Jawahri, who is an oncologist at Massachusetts General Hospital as well, who specializes in blood cancers. So I really opted to specialize in lung cancer because I thought that was the appropriate population to build a supportive and palliative care research agenda. Jennifer: Thanks.

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Illness Hospital Patient-Centered Patients 110

GeriPal

FEBRUARY 29, 2024

Anne: Well, speaking of your kids, a very special, sometimes listener, chimed in named Ren Smith. ” I think we started the blog in 2007 or 2008, we were doing that up until 2016. And, then around 2016 we were like, “We kind of need a new challenge, and that’s podcasting now.” Alex: Okay. ” Love it.

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IT Patient-Centered Illness Education 126

PEMBlog

MARCH 27, 2024

My special guest podcaster, Emily Groopman, is an actual Pediatric Geneticist in training and we hope that you will find this episode useful. 2016 Jan;37(1):3-15; quiz 16-7, 47. So my special guest host on this episode is a trainee in pediatrics and medical genetics. In: StatPearls [Internet]. Pediatr Rev. doi: 10.1542/pir.2014-0122.

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Consulting Individual Family Families 59

GeriPal

MARCH 28, 2024

The idea is, if it works at MGH, that’s a special kind of a place, maybe they do palliative care differently, maybe they have better resources, would this work at other transplant centers that have different kinds of clinicians or that serve different kinds of patients; so we wanted to have diversity of sites and clinicians and patients.

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Consulting Patient-Centered IT Patients 115

GeriPal

OCTOBER 10, 2024

In 2018, survey data revealed that only 41% of survey adult practices had the full complement of funded core team members, which is up from 25% of 2016. There are very few palliative care fellowships for social workers, very few specialized programs who teach palliative care as a specialty area. The National Palliative Care Registry.

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Screening IT Family Families 120

GeriPal

APRIL 10, 2025

primary palliative care interventions seem to fail, whereas specialized palliative care interventions have a relatively robust track record of success. I think back in what, May 2016, you published a randomized controlled trial, first author, palliative care and the ED randomized study, cancer patients. Why do so many (most, all??)

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Patient-Centered IT Hospital Patients 77

GeriPal

AUGUST 25, 2022

Eric: Alex, we have a super special today. We’ve got a hospice super special. Alex: We have a hospice super special day. Eric: We have a smorgasbord, if you will, of papers that got published recently around hospice, and that’s why we’re calling it a hospice super special. -@AlexSmithMD. Transcript.

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Family Families IT Patients 106

GeriPal

APRIL 14, 2022

We got some really special guests with us. So I have thought about this for months, maybe years since your 2016, cycle blog, but we have picked Under Pressure by David Bowie and Queen. And so that lends it properties of being a pretty strong analgesic and it lends its special properties for safety, from a safety profile.

Illness 102

Illness Patient-Centered IT Patients 102

GeriPal

MARCH 30, 2023

It feels special to me. As I was cleaning up my office, I found something I’d written in 2016. Then as I came, as it took shape and to closer to what it is now, I took a step back and looked at it and just felt like what is this? I don’t know what this is. It feels important to me. It’s funny, I just tucked it aside.

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IT Patient-Centered Patients Healthcare 96

GeriPal

JULY 25, 2024

Eric 00:13 And Alex, we have a super special today, three different articles. Alex 00:18 Prognosis, super special today. God, it must have been like 2015, 2016. Eric 25:08 Super special. Eric 47:55 And thank you to all of our listeners for joining us on this prognosis… Alex 48:00 Super special e P rognosis.

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Family Families Patient-Centered Patients 106

GeriPal

APRIL 20, 2023

Alex: But the longer title’s Ethno-Geriatrics and Special Populations. I remember deep in the recesses, 2016, I think it was, a New England Journal piece came out saying that we need to reframe the debate about cost. Margot: Yes. So they basically stayed housed. Eric: So I’ve got a question for you. Margot: Yeah.

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Mental Health IT Community Individual 123

GeriPal

DECEMBER 21, 2023

2015, 2016. And then 2016 after CMMI finished the evaluation, it looked good, nothing happened. He created fee for service, special fee for depression. What we didn’t have was the payment model to deliver the comprehensive dementia care. That’s what Malaz is going to talk about. Malaz: Yeah. And I talked with Jürgen.

Patient-Centered 125

Patient-Centered IT Family Families 125

GeriPal

JANUARY 5, 2023

Robert was first asked by one of his own patients for assistance in dying in 1991, far before aid in dying was legalized in California in 2016. There’s nothing special about it. I don’t think it needs a special term particularly. Today, medical aid in dying is legal in some 10 states, and illegal in others. .

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Provider Medical Hospital IT 19

FDA Law Blog

JUNE 23, 2024

In 2016, DEA issued a guidance letter to at least one company stating that delivery or dispensing to a practitioner’s office for administration to the patient was not addressed in the CSA or DEA regulations and therefore not specifically prohibited. the “ultimate user”).

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IT Medical Patients Specialization 98

FDA Law Blog

NOVEMBER 8, 2023

Koblitz & Philip Won — The first anniversary is always special. Following this, in June 2016, the National Academies of Sciences, Engineering, and Medicine (NASEM) made a similar recommendation of creating a new category of OTC “wearable hearing devices.” By Jeffrey N. Gibbs & Sara W.

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Utilities IT Engineering Appointment 64