HIT Consultant

NOVEMBER 24, 2022

First, let’s examine the new regulatory framework the FDA established. For the first time, all hearing aids will fall under two categories: prescription hearing aids and OTC hearing aids. The regulations limit the OTC hearing aid category to individuals with “perceived mild to moderate hearing impairment.”

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Health Blawg

DECEMBER 26, 2017

The FDA had a digital health banner day on December 7, announcing one final guidance and two draft guidance documents (with a 60-day comment period). FDA has done a very good job of moving the ball forward, though there is certainly room for improvement, and there is opportunity for comment on two of the three guidance documents announced.

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Health Law Advisor

MARCH 1, 2023

To provide more value to readers, I’ve started submitting FOIA requests for unpublished data to produce additional insights into how FDA works. And what better first topic than data on FDA responses to FOIA requests. FDA has been releasing data on its FOIA process, specifically its FOIA logs , for a few years. We were wrong.

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Health Law Advisor

APRIL 4, 2023

Continuing my three-part series on FOIA requests using a database of over 120,000 requests filed with FDA over 10 years (2013-22), this month’s post focuses on sorting the requests by topic and then using those topics to dive deeper into FDA response times. In the post last month, I looked at response times in general. 483/EIR Drug 6.

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Bill of Health

JANUARY 26, 2024

It is time to talk about why we include (and exclude) particular drugs from this category. Besides grants for “psychedelic” research, the FDA just released draft guidance on considerations for psychedelic clinical investigations with an ambiguous definition of what is considered to be a “psychedelic.”

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Health Law Advisor

MAY 2, 2023

In prior posts here and here , I analyzed new data obtained from FDA through the Freedom of Information Act about FOIA requests. The ones that seem to fall into somewhat defined categories include the following: 2. I looked at response times and then started to dive into the topics that requesters were asking about. 483/EIR Drug 6.

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HIT Consultant

JANUARY 24, 2023

The Food and Drug Administration (FDA) tracked the potential cybersecurity risks associated with both insulin and glucose monitors, noting these devices need to be reliable and trustworthy as users are pairing them with other system components such as smartphones.

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Health Blawg

DECEMBER 26, 2017

The FDA had a digital health banner day on December 7, announcing one final guidance and two draft guidance documents (with a 60-day comment period). FDA has done a very good job of moving the ball forward, though there is certainly room for improvement, and there is opportunity for comment on two of the three guidance documents announced.

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Health Blawg

DECEMBER 26, 2017

The FDA had a digital health banner day on December 7, announcing one final guidance and two draft guidance documents (with a 60-day comment period). FDA has done a very good job of moving the ball forward, though there is certainly room for improvement, and there is opportunity for comment on two of the three guidance documents announced.

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FDA HIPAA Compliance 60

Health Blawg

DECEMBER 26, 2017

The FDA had a digital health banner day on December 7, announcing one final guidance and two draft guidance documents (with a 60-day comment period). FDA has done a very good job of moving the ball forward, though there is certainly room for improvement, and there is opportunity for comment on two of the three guidance documents announced.

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FDA HIPAA Compliance 60

Health Blawg

DECEMBER 26, 2017

The FDA had a digital health banner day on December 7, announcing one final guidance and two draft guidance documents (with a 60-day comment period). FDA has done a very good job of moving the ball forward, though there is certainly room for improvement, and there is opportunity for comment on two of the three guidance documents announced.

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Health Law Advisor

JANUARY 31, 2023

The Food and Drug Administration (FDA) recently issued both draft and final guidance regarding food allergen labeling requirements. FDA does note that if such measures cannot eliminate cross-contact, manufacturers will often use advisory statements to alert allergic consumers to the potential for cross-contact.

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Exeed Regulatory Compliance

MARCH 22, 2020

A new FDA guidance provides much-needed relief during a pandemic. FDA has just revised its relatively less known 2012 guidance entitled “Post-market Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic” to clarify that the guidance is applicable to any pandemic, not just an influenza pandemic.

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HIT Consultant

NOVEMBER 27, 2023

Core Pillars of Collaboration The collaboration focuses on three core pillars: joint development and clinical validation of radiology products, extension into other diagnostic categories, and leveraging Annalise.ai’s AI solutions to enhance Mass General Brigham’s data assets for clinical and research missions.

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Bill of Health

JANUARY 28, 2022

Food and Drug Administration (FDA), under which the agency does “not consider it appropriate to add vitamins and minerals to alcoholic beverages.” FDA similarly discourages companies from fortifying snack foods to avoid misleading consumers about their health value. But what about that FDA policy on fortification?

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HIT Consultant

JANUARY 24, 2023

The Food and Drug Administration (FDA) tracked the potential cybersecurity risks associated with both insulin and glucose monitors, noting these devices need to be reliable and trustworthy as users are pairing them with other system components such as smartphones.

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Compliance Now

AUGUST 1, 2022

Covered plans are required to automatically cover a least one form of contraception in each of the categories below without applying medical management. Other types of contraceptive services or products approved by the FDA must also be covered, even if they do not fall into one of the categories listed above. Medical Management.

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Healthcare IT Today

MARCH 29, 2024

Food and Drug Administration (FDA) to detect, outline, and quantify instances of oral disease, with millimeter-level precision. Across multiple FDA studies, almost every general dentist was more accurate in detecting cavities and calculus when using Overjet. Its platform is the only technology cleared by the U.S.

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Health Law Advisor

NOVEMBER 1, 2022

The motivation for this month’s post was my frustration with the techniques for searching the FDA’s 510(k) database. Here I’m not talking about just using the search feature that FDA provides online. You can search that database using the so-called AccessGUDID through an FDA link that takes you to the NIH where the database is stored.

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Health Populi

OCTOBER 6, 2021

Digital health as a category has been a growing feature at CES for over a decade, starting with the early wearable tech era of Fitbit, Nike, Omron and UnderArmour, early exhibitors at CES representing the category. It’s timely, then, that CES launched the Global Women’s HealthTecb Awards collaborating with the World Bank.

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Dot Compliance

MARCH 30, 2022

The bar chart of your defect categories is arranged in descending order, and the line graph is added to track the cumulative percentage total. Quantifying Categories for a Pareto Diagram. Once your categories are defined, you can arrange the bars representing each category on your chart in descending order from left to right.

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Kaiser Permanente

FEBRUARY 23, 2022

As patients, providers, and health systems continue to grapple with unsustainably high drug prices in the United States, it is important for policymakers to understand the distinct differences between broad categories of therapies as they examine potential solutions. FDA risk evaluation and mitigation strategy (REMS).

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Florida Health Care Law Firm

MARCH 22, 2022

Before issuing regulations to add drugs or categories of drugs to the difficult to compound list, the Secretary must convene and consult an advisory committee. Further, in 2013, the FDA invited all interested persons (practitioners, pharmacists, consumers, and others) to nominate drug products to be included on the list.

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HIT Consultant

JANUARY 21, 2022

– The Series B funding will allow Casana to accelerate FDA submission of the Heart Seat with the goal to obtain FDA approval and bring this important new device to patients in 2022. Casana is unlocking a new category in healthcare technologies that enable effortless, integrated and consistent in-home heart health monitoring.

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Health Law Advisor

JULY 5, 2022

To help medical device manufacturers focus on the types of quality problems that might force them to conduct a recall, we have used the FDA recall database to identify the most common root causes sorted by the clinical area for the medical device. This heat map shows everything from one recall to 150 in each category. Background.

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HIT Consultant

MAY 2, 2022

FDA-Cleared Blood Pressure Monitor. The company’s flagship solution is an FDA-cleared blood pressure monitor coupled with an app. The Hello Heart app has shown the highest engagement rate in the category, with sustained long-term app engagement. Hello Heart’s solution is now available to millions of members.

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Health Law Advisor

AUGUST 2, 2022

My goal in nearly every device submission is to try to get through the FDA process with as little attention from FDA as possible. But when a seasoned person looks at it who has experience with FDA, their first thought is, do I really want FDA more involved in the process? Free advice! That’s not a criticism.

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Health Populi

DECEMBER 27, 2021

Digital health as a category has been a growing feature at CES for over a decade, starting with the early wearable tech era of Fitbit, Nike, OMRON and UnderArmour, early exhibitors at CES representing the category. It’s timely, then, that CES launched the Global Women’s HealthTecb Awards collaborating with the World Bank.

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Health Populi

JANUARY 6, 2023

The biggest, most visible category here is focusing on blood pressure , which has been a growing digital health focus expanding at CES annually over the past decade. Now, Valencell is out and proudly getting into chronic disease management with this program, pending FDA clearance to help patients manage hypertension. In the U.S.

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HIT Consultant

JULY 19, 2023

The funding will enable team expansion as SiPhox Health works towards FDA clearance for its SiPhox Home platform, which will offer a broad menu of proteins and hormone tests from a finger prick blood sample, with results in five minutes or less.

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Natalia Mazina

DECEMBER 13, 2023

The USP made changes to BUD assignment to compounding products under Category 2 and 3 (which are medium and high risk products in terms of susceptibility to microbial contamination). To facilitate patient access, the BUD for aseptically prepared Category 2 preparations is extended if only sterile ingredients at room temperature were used.

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HIT Consultant

SEPTEMBER 26, 2023

What You Should Know: Exo (pronounced “echo”), a medical imaging software and device company, today unveiled a category-redefining handheld ultrasound device, Exo Iris™, to put high-performance medical imaging into the hands—and pockets—of every caregiver.

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Jane Sarashon

JULY 15, 2022

Watch for the emerging segment of over-the-counter hearing aids to ratchet up in growth, with the FDA’s final ruling expected soon. This category will see double-digit growth of 17% in 2022 (estimated) and 14% next year, CTA forecasts, with an average unit price of about $50.

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HIT Consultant

MAY 12, 2022

Notable transactions in the consumer and member tech category include: Pear Therapeutics , software-based medicine provider, made its mark in 2017 as its tool became the first digital therapeutic approved by the FDA with claims to improve clinical outcomes. buyout, which was quickly followed by its IPO in June 2021. .

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Health Law Advisor

SEPTEMBER 6, 2022

A private equity client asked us recently to assess a rumor that FDA was on the warpath in enforcing the 510(k) requirement on medical devices from a particular region. The FDA’s recent activities in the region were well within their historical norms. To be sure, FDA can have multiple reasons for refusing entry. Background.

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HIT Consultant

JUNE 11, 2023

The reason is that embedded IoT devices – which both categories are part of – carry significant volumes of legacy software and run on limited-power computing hardware. Both are costly to change.

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Health Populi

AUGUST 9, 2019

Lisa Gill of Consumers Union, publisher of Consumer Reports , was one of several dozen presenters at a recent FDA hearing on CBD regulatory issues (detailed below in the Hot Points ). Here’s a link to the FDA’s FAQs on CBD. Already, we know from the Consumer Reports FDA testimony from May 2019 that one in five U.S.

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