The Medical Futurist

JUNE 21, 2025

Researchers say that the implant cannot provide any highly detailed vision – but it can help patients detect distinct patterns such as door frames and shapes. Their research showed promising results for lab rats, and they plan to carry out the first human trials in the second half of 2017 and gather preliminary results during 2018.

Diabetes 98

Diabetes Patient-Centered IT Patients 98

FDA Law Blog

NOVEMBER 20, 2024

The draft guidance provides recommendations for collection and reporting of chemical characterization data and discusses the topics of information gathering, test article extraction, chemical analysis, and data reporting. of ISO 10993-1:2018, but is extremely burdensome and not referenced in the related ISO 10993-18.

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Provider Medical Manufacturing Consulting 59

FDA Law Blog

MAY 13, 2024

RWD can be collected from a wide range of sources, such as electronic health records, registries, administrative claims, pharmacy data, and feedback from wearables and mobile technology. Rather than looking at how RWD/RWE provide meaningful information on safety and effectiveness, reviewers often focus on perceived gaps.

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Medical Clinic Patients IT 111

FDA Law Blog

NOVEMBER 9, 2021

Lenz, Senior Medical Device Regulation Expert — FDA introduced electronic copies (eCopies) of 510(k)s in 2013 (see our prior blogs here and here ) as a way to reduce the need for submission of paper copies of 510(k)s to the Agency. This pilot program, which utilized FDA’s eSubmitter electronic submission template, ended in May 2021.

Electronics 40

Electronics Physicals Provider Utilities 40

FDA Law Blog

SEPTEMBER 11, 2023

The electronic Submission Template and Resource (eSTAR) program, which we blogged about here and here , also makes the highlight reel given its aim to improve consistency and efficiency in how 510(k)s are prepared.

Medical 64

Medical Electronics Manufacturing Utilities 64

FDA Law Blog

OCTOBER 20, 2021

Reynolds (RJR) Vapor Company’s Vuse Solo electronic nicotine delivery system (ENDS) device and accompanying tobacco-flavored e-liquid pods, specifically, Vuse Solo Power Unit, Vuse Replacement Cartridge Original 4.8% FDA Provides Update on Pending PMTAs. By David B. Clissold — On October 12, 2021, FDA authorized the marketing of R.J.

Electronics 52

Electronics Provider Manufacturing IT 52

FDA Law Blog

SEPTEMBER 26, 2022

provides an optional alternative streamlined approach for current good manufacturing practices (cGMPs) for manufacturers of drug-device combination products (CPs). FDA published a proposed list on June 13, 2018 (83 FR 27609), which we blogged about here. 21 C.F.R. § or that FDA proposes can satisfy the requirements in § 4.4

Manufacturing 40

Manufacturing Specialization Provider Medical 40

FDA Law Blog

JULY 10, 2023

By Day 100 If MDUFA Decision is not reached by Day 100, FDA provides Missed MDUFA Decision Communication that identifies outstanding review issues. Performance Metric FY 2018 FY 2019 FY 2020 FY 2021 FY 2022 Average Number of FDA Days to MDUFA IV Decision 72.62 By Day 90 FDA sends final MDUFA Decision on 510(k).

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Provider IT Engineering Medical 75

FDA Law Blog

JULY 7, 2021

In March 2020, FDA issued a final rule that banned the use of Graduated Electronic Decelerators (GEDs) to treat patients with severe self-injurious and aggressive behaviors (SIB/AB), but did not restrict the use of these same devices for other purposes, like smoking cessation. FDA cleared 510(k)s for GEDs in the 1990s.

Medical 52

Medical Patient-Centered Patients IT 52

FDA Law Blog

DECEMBER 18, 2022

In August 2018, FDA published a notice in the Federal Register granting an alternative under 21 C.F.R. The draft guidance provides information about the VMSR Program eligibility and scope, reporting conditions, and the reporting process. Summary malfunction reports should be submitted electronically on Form FDA 3500A.

Medical 59

Medical Manufacturing Individual Provider 59

GeriPal

JULY 21, 2022

Eric: For those of you don’t know, Emmy was on our podcast back in 2018 … man, pre-COVID times. So that’s a piece that I think is important for providers anywhere along that process to be asking about driving. And the primary care provider had assumed he was no longer driving, I think. Emmy: Yeah. Emmy: Yeah.

IT 102

IT Families Family Diagnosis 102

GeriPal

SEPTEMBER 7, 2023

William: So ASCO decided to make a high priority this year to redo the guidelines, which were originally released in 2018. So pretty soon, I hope, we’ll be able to do this all electronically by anyone who wants to. Or electronically, to fill out, right? ” And we can by targeting these supportive care interventions.

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Patient-Centered IT Patients Clinic 130

GeriPal

JULY 13, 2023

Summary Transcript Summary Today’s podcast is a follow up to our 2018 podcast with Randy Curtis about the Jumpstart intervention. I wonder if we can just start off just going back a little bit because we had Randy on back in 2018 talking about Jumpstart, priming patients to do goals of care conversations. Am I summarizing that right?

Patient-Centered 84

Patient-Centered IT Patients Hospital 84

FDA Law Blog

JUNE 10, 2025

One commenter, without providing details, asserted that the chemical may have uses in the medical field. Public comments must be submitted electronically or postmarked on or before July 3, 2025. 23,477 (June 3, 2025). to schedule the substance to meet minimum requirements of the treaty.

Specialization 69

Specialization Manufacturing Electronics PCP 69

GeriPal

MARCH 27, 2025

And so a lot of it was the facilitators calling out with the approval of the provider to the patients ahead of time to see, like, you have a visit coming up. So we have to collect what information we have available from Health Information exchange and electronic health records. What’s in the electronic health record?

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Primary Care IT Clinic Illness 80

GeriPal

FEBRUARY 24, 2022

And so the definition of advance care planning really switched in, I think, 2017, 2018, there was kind of a United States definition and then an international consensus definition. And I also think, we still operate under pay for… We get paid for the services we provide, right? What are your values? Eric: Yeah. Eric: Yeah.

Illness 98

Illness Patient-Centered IT Patients 98

Physician's Weekly

JUNE 25, 2025

Health insurers will still be allowed to deny doctor-recommended care, which is arguably the biggest criticism that patients and providers level against insurance companies. He noted that health insurers made “past promises” to improve prior authorization in 2018. Prior authorization isn’t going anywhere.

Insurance 52

Insurance Patient-Centered Patients Government 52

Physician's Weekly

JUNE 17, 2025

Prior authorization varies by plan but often requires patients or their providers to get permission (also called precertification, preauthorization, or preapproval) before filling prescriptions, scheduling imaging, surgery, or an inpatient hospital stay, among other expenses. . ” An Unintended Consequence of Health Reform?

Insurance 52

Insurance Patients Behavioral Health Services Diagnose 52

FDA Law Blog

FEBRUARY 5, 2025

This proposed rule follows FDAs March 2018 advance notice of proposed rulemaking (ANPRM) regarding a potential maximum nicotine level for cigarettes. It would not apply to electronic nicotine delivery systems (ENDS) smokeless tobacco products, nicotine pouch products, or other non-combusted tobacco/nicotine products.

Manufacturing 66

Manufacturing Engineering Electronics IT 66

Physicians News Digest

APRIL 3, 2025

Survey data gathered by AHRQ provides much of what is known about hospitalizations for motor accidents, measles, methamphetamine, and thousands of other medical issues. But when the Trump administration proposed merging it with NIH in 2018, a House-ordered study into health research priorities validated AHRQ’s valuable role.

Patient-Centered 52

Patient-Centered Hospital Diagnose Medical 52