FDA Law Blog

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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Sound Physicians

MARCH 12, 2025

While we primarily partner with our own Sound specialty teams , we also work independently with employed and other outsourced clinical teams. Posted in Critical Care Share Article Subscribe to the Sound Physicians Blog A trusted source for todays healthcare needs.

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FDA Law Blog

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. eSTAR will prompt for attachments when necessary; this includes financial certifications and disclosure statements for the section of clinical testing. (A

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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. These clinicians recount rigorous efforts directed towards improving their knowledge and clinical skills.

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FDA Law Blog

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.

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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. During the appointment, you discuss your symptoms and clinical records. You will get hold of prescriptions electronically, and And observe-up visits manifest thru video or smartphone calls.

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FDA Law Blog

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. By Adrienne R. The Draft Guidance provides specific examples illustrating the application of each scenario.

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FDA Law Blog

MAY 4, 2023

Cato — On May 2nd, FDA released a new draft guidance with recommendations for decentralized clinical trials (DCTs) for drugs, biologics, and devices. In a DCT, trial-related activities may occur in trial participants’ homes, at local health care providers’ offices, or in local clinical laboratories.

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FDA Law Blog

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 Blog

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 Blog

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 Blog

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 Blog

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. FDA suggests that simulated use/leachables studies to simulate the clinical use (i.e.,

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FDA Law Blog

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 Blog

APRIL 20, 2021

Certain types of clinical decision-support software. Calculator/Data Processing Module for Clinical Use. Medical Device Data System. Remove non-device software functions intended for transferring, storing, converting formats, or displaying clinical laboratory test or other device data and results. By McKenzie E.

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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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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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The Motivated MD

OCTOBER 10, 2024

So, with this chapter, I hope to briefly touch on the basics of market investing and describe why simple diversification and index fund investing are the most effective ways for busy clinical physicians and healthcare providers to invest with the expectation of long-term gains. Most clinical physicians are busy.

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FDA Law Blog

FEBRUARY 15, 2023

By Véronique Li, Senior Medical Device Regulation Expert & Allyson B. These regulations apply to radiation emitting products, including not just medical devices but all other radiation emitting products as well. Mullen — Sections of the radiological health regulations have been updated with the goal of lessening regulatory burdens.

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FDA Law Blog

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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FDA Law Blog

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 Blog

OCTOBER 24, 2022

These data are routinely collected from a variety of sources, such as electronic health records, providing information on health and healthcare in actual patients, rather than in the controlled environment of a clinical trial. This value is potentially even greater for rare diseases, where there are limited sources of data.

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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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FDA Law Blog

FEBRUARY 28, 2023

Lenz, Principal Medical Device Regulation Expert — Since 2005, 510(k) submissions have been formatted according to FDA guidance Format for Traditional and Abbreviated 510(k)s. By Adrienne R. The guidance describes twenty sections to be included in a Traditional or Abbreviated 510(k).

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FDA Law Blog

AUGUST 29, 2021

electronic formatting for regulatory submissions), scientific (e.g., clinical testing of implanted brain computer interface devices for patients with paralysis or amputation), enforcement (e.g., FDA’s database contains 2,623 guidance documents that address a plethora of topics, ranging from the mundane (e.g.,

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FDA Law Blog

NOVEMBER 3, 2024

We have previously blogged about Jazz Pharmaceuticals ’ challenge to FDA’s clinical superiority decision concerning sodium oxybate in the treatment of narcolepsy. More on this case coming to the Blog soon. As that case seems likely to hit the Circuit Court of Appeals’ docket, another example out of D.C.

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FDA Law Blog

JULY 7, 2024

The guidance restates the central premise of the final rule, i.e., that LDTs are medical devices and the clinical laboratories that design, manufacture and use them to test patient specimens are manufacturers. 803), Reporting of Corrections and Removals (21 C.F.R. § 806) and Complaint Files (21 C.F.R. 820.198). .

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GeriPal

FEBRUARY 29, 2024

Accreditation In support of improving patient care, UCSF Office of CME is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.

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FDA Law Blog

JANUARY 8, 2023

The enactment of the Medical Marijuana and Cannabidiol Research Expansion Act (“the Act”) into law (Public Law 117-215) last month is a step in that direction. To date 39 states and the District of Columbia have legalized cannabis for medical use (and 21 for adult recreational use), mainly through ballot initiatives. 21 U.S.C. §

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GeriPal

DECEMBER 8, 2022

Integration of Person-Centered Narratives Into the Electronic Health Record: Study Protocol. Connection — The Integration of a Person-Centered Narrative Intervention into the Electronic Health Record : An implementation study. Eric’s blog post on Dignity Therapy from 2011. Bennett, C.R., Schilling, L., Doorenbos, A.

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GeriPal

DECEMBER 15, 2022

And then we also have another Vas, many of the interviews are done by medical students or other healthcare trainees as part of their clinical rotation at the VA. And so mine is here at the University of Colorado system, so a non-VA system, so different electronic health records, we have Epic. I was successful and had funding.

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PEMBlog

MARCH 27, 2024

She is a member of the Clinical Genome Resource Inborn Errors of Metabolism (IEM) Clinical Domain Working Group, where as a biocurator she assesses the pathogenicity of variants in IEM-associated genes to facilitate expedited genetic diagnosis for IEMs. Brad’s not a pediatric medical geneticist. On clinical presentation.

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GeriPal

APRIL 18, 2024

I remember walking through San Francisco Airport with Bob, we just happened to be there at similar times, and saying, “Eric and I are thinking about starting a blog.” Then, it was like, well, it does as well as, and now, better than humans passing the medical boards, passing the law boards, doing great on the SAT, all that stuff.

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FDA Law Blog

MAY 21, 2024

The 2016 reviews concluded that marijuana continued to meet schedule I criteria for having a high potential for abuse, no currently accepted medical use in treatment in the U.S., and lacked accepted safety for use under medical supervision. 21 U.S.C. § 21 U.S.C. § 21 U.S.C. § Basis at 18; NPRM at 44,605. NPRM at 44,607.

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GeriPal

SEPTEMBER 19, 2024

Eric 07:31 A clinical perspective, why is it important to test this stepped care model versus implementing more? And now when I think about the clinic at Duke, when we’re really running on all cylinders, we can get ourselves up to a five, six, seven week wait for a new palliative care referral. This is Eric Widera.

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