FDA Law Blog

JULY 6, 2023

By Véronique Li, Senior Medical Device Regulation Expert — Earlier this year, neither the Quality System Regulation (QSR) nor the Quality Management System Regulation (QMSR) were referenced in the semiannual regulatory agenda. According to the Unified Agenda, the proposed rule is in the final rule stage.

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FDA Law Blog

DECEMBER 1, 2024

Management, according to the Warning Letter, “stated that the investigators were not allowed to take photographs of the equipment as part of the inspection.” In September 2016, Nippon Fine Chemical received a similar Warning Letter about an attempt to prevent an FDA Investigator from taking photographs.

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The Medical Futurist

MAY 18, 2025

We have seen a number of examples, Canada experimenting with robot-comrades since the 2016 introduction of Ludwig , and some elderly care facilities in Ireland introducing Stevie to their residents. Robotic medical dispenser systems, medication management solutions help any given facility “right-size” its system for its volume.

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FDA Law Blog

OCTOBER 27, 2022

The updated final guidance now also incorporates ICH Q12 Technical and Regulatory Considerations for Pharmaceutical Product lifecycle Management. The final guidance includes several changes that are summarized below.

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FDA Law Blog

FEBRUARY 21, 2024

Mullen — More than five years after FDA first announced its plan to harmonize 21 CFR Part 820 with ISO 13485, on February 2, 2024, FDA finally issued the Quality Management System Regulation (QMSR) Final Rule. The final rule emphasizes risk management activities and risk-based decision making. The new § 820.10

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FDA Law Blog

MARCH 6, 2022

Part 820, with a newly named Quality Management System Regulation (QMSR). The QMSR omits many of the specific QSR requirements that currently appear in the regulations, and instead incorporates by reference an international standard for medical device quality management systems.

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The Clinical Problem Solvers

APRIL 24, 2025

The episode also explores how digital tools can help youth manage their mental health, while also noting the need for culturally relevant care providers. 2016 Mar;67(3):324-31. Simon shares his work as Boston’s first Chief Behavioral Health Officer, prioritizing substance use treatment and uplifting Black and Indigenous communities.

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FDA Law Blog

APRIL 25, 2023

Note that section 3060(a) of the 21st Century Cures Act in 2016 amended section 520 of the FD&C Act and removed certain software functions from the statutory definition of a medical device. It applies whether the software is the entire device (i.e., Software in a Medical Device, or SiMD).

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The Clinical Problem Solvers

DECEMBER 16, 2020

However, the diagnostic approach used to determine changes in clinical management of renal disease (i.e. Additionally, research has shown that using symptom-prompted modifications to management, in the context of shared decision-making, can improve outcomes. 2016 Jul;91(7):916-20. September 12, 2018. Race Matters?

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FDA Law Blog

APRIL 11, 2022

Shapiro — One of the more complex areas of device regulation is the management of risks associated with malfunctions reported from the field. By Jeffrey K. A critical task in this situation is for a firm to estimate the risk posed by the issue as accurately as possible.

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FDA Law Blog

APRIL 20, 2021

Remove non-device software functions intended for storing and displaying medical images, clarify that the regulation includes software and hardware functions intended for medical image management and processing, and revise the title of the classification regulation to “Medical Image Management and Processing System”. By McKenzie E.

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FDA Law Blog

MAY 31, 2021

In addition, CMS proposes to extend the effective date of a 2016 regulation that requires AMP and Best Price to include sales to purchasers in the U.S. Territories (American Samoa, Northern Mariana Islands, Guam, Puerto Rico, and the U.S.

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PEMBlog

SEPTEMBER 24, 2024

Management of Congenital Lung Malformations. doi: 10.1128/microbiolspec.TNMI7-0032-2016. References Palla J, Sockrider MM. Congenital Lung Malformations. Pediatr Ann. 2019 Apr 1;48(4):e169-e174. doi: 10.3928/19382359-20190326-02. PMID: 30986318. Hegde BN, Tsao K, Hirose S. Clin Perinatol. 2022 Dec;49(4):907-926. doi: 10.1016/j.clp.2022.08.003.

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FDA Law Blog

FEBRUARY 22, 2023

And HF‑related AI requests are especially nerve‑racking to manage, because of the ever‑present threat that the study must be repeated to adequately respond. By Jeffrey K. Shapiro — More than a decade ago, FDA began systematically to incorporate review of human factors (HF) design validation within 510(k) reviews.

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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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FDA Law Blog

OCTOBER 10, 2022

The CDS Guidance interprets the “medical software” carve-out of the 21st Century Cures Act (2016) as it pertains to Clinical Decision Support (CDS) software functions. While the final guidance continues to borrow some IMDRF concepts, it no longer limits Non-Device CDS to software that informs clinical management (per the IMDRF guidelines).

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FDA Law Blog

MARCH 17, 2022

We blogged on the final 2016 guideline here on March 17, 2016). As explained more fully below, CDC concedes that states, insurers, pharmacies and pharmacy benefit managers have implemented laws, regulations and policies that have misapplied the 2016 guideline. 2016 Guideline. 7,838 (Feb.

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FDA Law Blog

NOVEMBER 29, 2022

Houck — On November 4th, CDC issued its revised guideline on prescribing opioids for pain as an expansion and update of its 2016 CDC Opioid Prescribing Guideline. We blogged on the 2016 guideline here in March 2016, and the proposed guideline here on March 18th). By Larry K. Dowell D, Ragan KR, Jones CM, Baldwin GT, Chou R.,

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Physician's Weekly

JUNE 11, 2025

Despite the emphasis on U=U as a key HIV prevention strategy since 2016, none of the included studies explicitly described U=U or U=U messaging as an intervention component,” the researchers wrote. Of the 669 participants, the mean age from studies was 45.4 years, and 91% of the participants were Black women with HIV.

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Permanente Medicine

APRIL 29, 2025

From 2012 to 2016, death rates from colorectal cancer among Black people were nearly 40% higher than in whites and double that seen in Asians and Pacific Islanders, according to the American Cancer Society. Deaths per 100,000 for Hispanic, white, and Asian patients decreased to 20 during the same time period.

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FDA Law Blog

MAY 5, 2024

The White House Office of Management and Budget will review the rescheduling proposal. FDA/HHS Analysis, 2023 FDA/HHS last conducted an eight-factor analysis of marijuana in 2016 and concluded that marijuana continued to meet schedule I criteria. 12, 2016); Denial of Petition to Initiate Proceedings to Reschedule Marijuana, 81 Fed.

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The Clinical Problem Solvers

MAY 30, 2022

Kozhimannil—the Distinguished McKnight University Professor in the Division of Health Policy and Management at the University of Minnesota and Director of the Rural Health Research Center. Published April 20, 2016. Healthcare. 2020;8(1):100367. doi: 10.1016/j.hjdsi.2019.100367 2019.100367 Plain C. link] Proujansky A. link] Norris L.

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GeriPal

MARCH 28, 2024

Eric: And that’s similar to the 2016 JAMA paper, right? Eric: And we’re going to get to results, but that’s why I also love that 2016 paper: I think it was the very first palliative care trial that ever looked at individuals getting curative therapy. Did it negate everything from the 2016 trial?Palliative

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FDA Law Blog

FEBRUARY 5, 2024

When finalized, the Draft Guidance will take the place of the 2016 guidance Collection of Race and Ethnicity Data in Clinical Trials. Instead, the information should be self-reported or, if that is not possible, provided by a first-degree relative or knowledgeable representative. The comment period ends on April 29, 2024.

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GeriPal

APRIL 14, 2022

Management of chronic pain in the elderly: focus on transdermal buprenorphine. 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 how am I going to manage their pain? Two great videos on buprenorphine initiation. Transcript.

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GeriPal

APRIL 3, 2025

We used all of our political capital to make sure it happens in Chicago, which is where we started for the literature Updates back in 2016, back when it was just me and Ken, and then we brought in Alex, like two years later. Annie 05:16 So if you look back in history, I think Eric and Ken have been doing this since 2016. Go Cubs, go.

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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. DorAnne 30:25 I also wanna make a shout out for pain and symptom management with social work and chaplains. So we totally forget that all of us are symptom managers as well.

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GeriPal

FEBRUARY 29, 2024

Alex: And, it means pain management. ” 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.” Eric: That was the SAT answer. ” [laughter] Lynn: Oh good God. ” Love it.

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GeriPal

JULY 28, 2022

But at that time I was struck by how in that field, there wasn’t a focus or really interest in symptom management and support for patients and their families. They supported patients, they gave them a holding environment, they did symptom management, yada, yada, yada, like all the things we know palliative care clinicians do.

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PEMBlog

MARCH 27, 2024

This episode will help you better prepare for and manage children with inborn errors of metabolism in the Emergency Department. 2016 Jan;37(1):3-15; quiz 16-7, 47. As always, I’m your host, Brad Sobolewski, and this episode focuses on the management of children with metabolic disorders who present to the emergency department.

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FDA Law Blog

JUNE 19, 2023

Cato — The long-running saga of FDA regulation of laboratory-developed tests (LDTs) has taken yet another new turn. Even if a final rule is issued, that will not be the end of the story.

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GeriPal

APRIL 10, 2025

I think back in what, May 2016, you published a randomized controlled trial, first author, palliative care and the ED randomized study, cancer patients. Eric 04:26 So that 2016 study was in the ED, but it was getting specialty palliative care to see them when they were hospitalized, is that right? Primary outcome was quality of life.

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FDA Law Blog

FEBRUARY 9, 2022

10, 2016); East Main Street Pharmacy; Affirmance of Suspension Order, 75 Fed. Improper Dosing for Pain Management. a circumstance that does or should raise a reasonable suspicion as to the validity of a prescription) unless he or it takes steps to resolve the red flag and ensure that the prescription is valid. Holiday CVS, 77 Fed.

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PEMBlog

DECEMBER 14, 2023

Learn all about diagnosis and management of this common problem in this brief podcast episode. 2016 Apr;83:78-83. So this management is conservative, includes upright feeding, antireflux therapy, so alterations to how you Feed, burp, and position. Isaac A, Zhang H, Soon SR, Campbell S, El-Hakim H. Int J Pediatr Otorhinolaryngol.

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GeriPal

JUNE 30, 2022

Should she be treated non-operatively, with aggressive symptom management? What does it mean for functional status, symptom management, location of care? Samir: As some of your audience may know, there are new billing codes introduced January 1st, 2016 to start reimbursing for having advance care planning discussions.

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GeriPal

JANUARY 11, 2024

The number of people who have used MAID in Canada since it was legalized in 2016 has increased year on year from about 1,000 people in the first year to over 13,000 people in 2022. You get me with one-finger-chords on the guitar if you’re watching on YouTube (best I could manage). Four percent. Eric: Yeah. Eric: Please.

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GeriPal

AUGUST 25, 2022

As a nurse case manager in hospice, half of my patients had dementia. Nurse case management, social worker case management, medications, medical equipment, a home health aid, all that stuff goes away. If yes, was it more, less, or the right amount of pain management? I just want to highlight some work.

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