ABIM

MARCH 27, 2025

To help advance this mission, ABIM and the ABIM Foundation are proud to sponsor the American Board of Medical Specialties (ABMS) Visiting Scholars Program , a year-long, part-time research program that supports early career physicians and researchers as they strive to become leaders in their field.

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Sound Physicians

MARCH 12, 2025

Posted in Critical Care Share Article Subscribe to the Sound Physicians Blog A trusted source for todays healthcare needs. Posted in Critical Care Share Article Subscribe to the Sound Physicians Blog A trusted source for todays healthcare needs. Receive blog updates directly to your inbox. All rights reserved.

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FDA Law

OCTOBER 5, 2022

The development of an electronic submission template for 510(k) submissions is significant in that: eSTAR submissions are not expected to go through the refuse to accept (RTA) process. Exemptions from the electronic submission requirements apply to interactive review responses and some amendments (e.g., add-to-files).

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FDA Law

JULY 12, 2022

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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FDA Law

SEPTEMBER 14, 2022

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.

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FDA Law

JULY 31, 2022

Mullen — On July 19, 2022, CDRH announced to users of its Customer Collaborations Portal (CCP) that it is now accepting premarket submissions electronically. As previously noted, this is very exciting news for the device industry, which up to this point has had to continue to ship electronic media to CDRH each time a submission is filed.

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Physician's Practice

JUNE 23, 2025

Reynolds Fact checked by Chris Mazzolini Blog Article Navigating the health tech landscape requires strategic diligence to avoid hidden costs and ensure seamless integration in medical practices. The health technology gold rush is back on, and sales reps know where to find you. Yet a single misstep can wipe out months of margin.

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FDA Law

OCTOBER 24, 2023

Mullen — As of October 1, 2023, all 510(k) submissions, unless exempted, must be submitted to FDA using the electronic Submission Template And Resource ( eSTAR ). Currently, eSTAR is voluntary for medical device De Novo submissions, but FDA has initiated the process of requiring De Novos to be submitted using eSTAR.

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FDA Law

AUGUST 9, 2023

However, electronic prescriptions for controlled substances (“EPCS”), which a practitioner transmits directly to a pharmacy, do not allow the patient such an option. Transfer of Electronic Prescriptions for Schedule II-V Controlled Substances Between Pharmacies for Initial Filling, 88 Fed. 48365, 48369 (July 27, 2023).

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FDA Law

JULY 31, 2023

In addition, a pharmacist could partially fill a schedule II prescription issued to patients in a Long Term Care Facility or who have a terminal medical illness diagnosis. 21 U.S.C. § The Final Rule a. Patient Request A patient may also request that their prescription for a schedule II substance be partially filled.

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Dr. Zaar

MAY 20, 2025

In this blog, we’ll answer the most common questions and explain why more people are choosing online hormonal therapy services across Canada. You will get hold of prescriptions electronically, and And observe-up visits manifest thru video or smartphone calls. What Is Hormonal Therapy? Is Online Hormonal Therapy Safe?

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FDA Law

FEBRUARY 9, 2024

Lenz, Principal Medical Device Regulation Expert & Lisa M. Baumhardt, Senior Medical Device Regulation Expert — As an end of the year gift, FDA finalized its guidance document, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations , in late December. By Adrienne R.

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The Clinical Problem Solvers

SEPTEMBER 28, 2019

This is a peer-nominated group of academic clinicians renowned for their medical knowledge, teaching & communication skills, professionalism, and high-quality patient care. It’s clear that clinical reasoning is a learned skill, one that can be honed by practicing cases, developing schemas, and expanding our medical knowledge.

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Noreta Family Medicine

JUNE 25, 2024

Although the medical focus of this video is obesity, I was intrigued by the other highlighted theme – the endless spool of red tape in healthcare. Insert a different medical problem and a different medicine, and this situation repeats itself daily in a primary care office.

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FDA Law

OCTOBER 5, 2022

Now, according to the Center’s announcement, anyone may request access to the CCP and begin filing premarket submissions electronically. On October 3, 2022, CDRH announced the expansion of this program. CDRH’s website provides a link to request access to the CCP ( here ).

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FDA Law

MARCH 8, 2023

By Véronique Li, Senior Medical Device Regulation Expert — On March 17, 2023, enhancements to FDA’s electronic Medical Device Reporting (eMDR) system will go live. Manufacturers who submit reports via the FDA Electronic Submissions Gateway are being advised to update their systems by this time.

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FDA Law

SEPTEMBER 11, 2023

Baumhardt, Senior Medical Device Regulation Expert & Adrienne R. Lenz, Principal Medical Device Regulation Expert — On September 6, 2023, FDA announced its latest efforts to modernize the 510(k) process, outlining FDA’s latest improvements to strengthen the 510(k) Program and announcing release of three draft guidance documents.

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FDA Law

JUNE 21, 2023

Cato — On June 1, CDRH announced that it is seeking public comment on questions regarding how CDRH can facilitate access to medical technologies designed for use outside of traditional clinical settings, particularly in the home. At-home medical technologies include, but are not limited to, monitoring and wearable devices (e.g.,

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FDA Law

SEPTEMBER 22, 2024

See our prior blog post summarizing the different phaseout stages and categories of enforcement discretion. See our prior blog post summarizing the different phaseout stages and categories of enforcement discretion. By Steven J. Gonzalez & Lisa M. It should be noted that 21 CFR 803.18(b)(1)(ii)

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FDA Law

DECEMBER 4, 2023

Pharmacists’ Corresponding Responsibility A controlled substance prescription, to be valid, must be issued for “a legitimate medical purpose by an individual practitioner acting in the usual course of [their] professional practice.” Zarzamora Press Release. The government asserted additional allegations that are outside our scope.

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FDA Law

NOVEMBER 20, 2024

Chemical characterization identifies and quantifies chemicals that may be released from the medical device, while a toxicological risk analysis (TRA) evaluates the risks to the patient associated with the chemicals identified. KP Medical Device Consulting LLC

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FDA Law

MAY 13, 2024

Gibbs & Ana Loloei & Véronique Li, Senior Medical Device Regulation Expert — FDA has long touted the use of real-world evidence ( RWE ). RWE is “the clinical evidence regarding the usage, and potential benefits or risks, of a medical product derived from analysis of RWD.” By Jeffrey N.

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FDA Law

JULY 7, 2021

Gibbs — In the first challenge ever brought against FDA’s rarely used power to ban a medical device, a court found FDA overstepped its authority and overturned the ban. Thus, the court concluded that FDA has no authority to choose what medical devices a practitioner prescribes or administers to its patients, which is what the ban did.

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FDA Law

OCTOBER 18, 2022

By Véronique Li, Senior Medical Device Regulation Expert & Philip Won — Last week, our blog post advised planning a transition strategy in advance of the news of the termination of the Covid-19 public health emergency. electronic thermometers, single lumen needles, piston syringes).

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FDA Law

MARCH 7, 2024

Tobolowsky & Véronique Li, Senior Medical Device Regulation Expert & David B. Moreover, DMCs are being used in trials of modest size and in the context of increased globalization of medical product development. DMC charters have also grown longer and more detailed. They also both stressed the value of previous DMC experience.

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FDA Law

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. By Adrienne R. FD&C Act Section 745(A)(b)(3)(A). Draft Guidance at 8.

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FDA Law

JUNE 27, 2023

By Véronique Li, Senior Medical Device Regulation Expert & Anne K. Walsh — Last fall, we blogged about the process FDA uses to review allegations of regulatory misconduct against device manufacturers, suggesting greater transparency on the FDA process was needed (see here ).

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The Motivated MD

DECEMBER 18, 2024

I am using our weekly blog posts to create a future book that hopefully will apply to medical trainees and early career physicians looking to build generational wealth, get out of debt, and take control of their financial lives. Infuse your budget, buy a new electronic, place it in cryptocurrency, whatever.

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Physician's Practice

JUNE 25, 2025

Reynolds Blog Video Neil Baum, MD, asks whether your patients are satisfied with their care and shows how a quick survey could make the difference. Dr. Baum is Professor of Clinical Urology at Tulane Medical School in New Orleans, Louisiana. Dr. Baum was the columnist for American Medical News for more than 25 years.

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FDA Law

APRIL 20, 2021

Medical Device Data System. Medical Image Storage Device. Remove non-device software functions intended for storing and retrieving, so that a medical image storage device is a hardware device that provides electronic storage and retrieval functions for medical images. Medical Image Communications Device.

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FDA Law

OCTOBER 18, 2023

Lenz, Principal Medical Device Regulation Expert — Although it seems not widely known outside of the medical device industry, FDA can require sponsors to include clinical data as part of a 510(k) submission. electronic health records, claims). electronic health records, claims). By Adrienne R.

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PEMBlog

AUGUST 30, 2023

This is a blog post and a podcast episode designed to disseminate the important work of Choosing Wisely , an initiative of the the American Board of Internal Medicine Foundation, the goal of which is the spark conversations between clinicians and patients about what tests, treatments, and procedures are needed – and which ones are not.

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Aspiring Minority Doctor

MARCH 26, 2021

I'm finally ready to share a bit of my testimony, so read on if you'd like to know how God worked everything out in my favor :) If you've been following my blog, then you already know I was reapplying this year, but didn't want to share any details until after Match Day.

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FDA Law

SEPTEMBER 17, 2023

By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — Over the last three and a half years, meetings with FDA were conducted virtually. Additionally, recent visitors did not have to scan their identification cards through an electronic machine. Our recent experiences indicate that is no longer the practice.

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FDA Law

JULY 10, 2023

Lenz, Principal Medical Device Regulation Expert — It takes a significant amount of time, cost, and effort to prepare a premarket notification 510(k) submission. In this blog post, we will first briefly outline the procedural steps in the 510(k) review process for medical devices. By Philip Won & Adrienne R.

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FDA Law

JANUARY 5, 2023

In mid-November, FDA collaborated with the MITRE Corporation to publish an update to the Medical Device Cybersecurity Regional Incident Preparedness and Response Playbook. Combination products are sharing the digital moment with those classified solely as medical devices.

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Physician's Practice

JUNE 20, 2025

Reynolds Blog Article Innovative medical practices thrive by embracing change, prioritizing patient care and learning from setbacks to enhance success and satisfaction. This blog will discuss what early adopters do to implement innovative and exciting practices.

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