2019, Manufacturing, Medical and Provider

9 Technologies That Will Shape The Future Of Dentistry

The Medical Futurist

JUNE 17, 2025

Just like in the case of other medical specialties , disruptive innovations will have a huge impact on how dentistry will be practiced and how patients will take care of themselves in the future. Researchers in 2019 developed a machine learning method to accurately quantify immune cells in the vicinity of oral cancer cells.

Patients

Patients Treatment Plan Healthcare Medical Specialty

Change is Inevitable – Plan Ahead: An Assessment of FDA’s Draft Guidance on Predetermined Change Control Plans for Artificial Intelligence/Machine Learning-Enabled Device Software Functions

FDA Law Blog

MAY 8, 2023

Baumhardt, Senior Medical Device Regulation Expert & Philip Won & Gail H. In February 2020, FDA granted a de novo classification request (DEN190040) for software intended to assist medical professionals in the acquisition of cardiac ultrasound images and that included a PCCP for future software modifications.

Manufacturing

Manufacturing Provider Medical IT

Indeterminate Change: FDA Releases Draft Guidance on Predetermined Change Control Plans for Medical Devices

FDA Law Blog

OCTOBER 2, 2024

Lenz, Principal Medical Device Regulation Expert & Lisa M. Baumhardt, Senior Medical Device Regulation Expert & Gail H. If a sponsor is able to provide a detailed description of multiple changes with appropriate performance evaluation methods for each, we hope the Agency will be willing to consider them under a single PCCP.

Medical

Medical Specialization Manufacturing IT

A Question 30 Years in the Making: Would a Final LDT Rule Withstand Judicial Scrutiny?

FDA Law Blog

NOVEMBER 1, 2023

Lenz, Principal Medical Device Regulation Expert & Sophia R. Gibbs — For more than three decades, FDA has claimed that the Federal Food, Drug & Cosmetic (FD&C Act) gives the agency legal authority to regulate laboratory developed tests (LDTs) as medical devices (see our prior post here ). Gaulkin & Jeffrey N.

Manufacturing

Manufacturing Hospital Healthcare Medical

Let’s Listen to Patients: FDA Releases Final Guidance on Patient Engagement in the Design and Conduct of Medical Device Clinical Studies

FDA Law Blog

FEBRUARY 28, 2022

Bauer, Senior Regulatory Drug Expert — Our readers probably know that we value and advocate for patient engagement as an essential component in the development of medical products (see our firm’s commitment here ). The Guidance provides practical advice for device manufacturers to utilize patient engagement in clinical studies.

Patients

Patients Clinic Medical Patient-Centered

Minnesota Proposes to Reduce Opioid Product Registration Fees Related to Hospitals

FDA Law Blog

JUNE 28, 2021

If enacted, Article 5, Section 6 of HF33 would provide for a reduction to the State’s opiate product registration fee. Manufacturers would still be required to report sales of these products to the Board of Pharmacy, but they would not be factored into the determination of the opiate product registration fee.

Hospital

Hospital Manufacturing Specialization Medical

510(k) Modernization 2023

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.

Medical

Medical Electronics Manufacturing Utilities

Could the Road to an AKS Violation Be Paved with Good Intentions? Pfizer Asks SCOTUS

FDA Law Blog

NOVEMBER 6, 2022

Pfizer manufactures tafamidis (sold under brand names Vyndaqel and Vyndamax), a breakthrough treatment for a rare, progressive heart condition called transthyretin amyloid cardiomyopathy (ATTR-CM). In June 2019, Pfizer sought an OIG advisory opinion to ensure that its proposal would not run afoul of federal law. Background.

Manufacturing

Manufacturing Patient-Centered Healthcare Utilities

The Incredible Shrinking Exemption: FDA Final CDS Guidance Would Significantly Narrow the Scope of Exempt Clinical Decision Support Software Under the Cures Act

FDA Law Blog

OCTOBER 10, 2022

Javitt — On September 28, 2022, the FDA issued the long anticipated final Clinical Decision Support Software Guidance (CDS Guidance), which replaces the revised draft guidance document from 2019. Criterion 2 : Non-Device CDS software functions display, analyze or print medical information about a patient or other medical information.

Clinic

Clinic Medical Provider Patients

FDA Issues Unsupported Safety Warning Regarding Surgical Robots for Cancer Treatment

FDA Law Blog

OCTOBER 14, 2021

Food and Drug Administration (FDA) is reminding patients and health care providers that the safety and effectiveness of robotically-assisted surgical (RAS) devices for use in mastectomy procedures or in the prevention or treatment of breast cancer have not been established. In this safety communication, FDA states: The U.S.

Patient-Centered

Patient-Centered Healthcare Manufacturing Provider

Estimating Risk Associated with Medical Device Malfunctions: FDA’s Warning letter to Medtronic Highlights an Under Appreciated Potential Source of Error in the Estimation

FDA Law Blog

APRIL 11, 2022

Medtronic Warning Letter) provides an important reminder from FDA as to the correct estimation of risk associated with malfunctions. As background, Medtronic manufactures the MiniMed 600 series insulin infusion pumps. This estimation of risk is important because it drives both decision making and regulatory compliance.

Medical

Medical Management Manufacturing Patients

Big Win for HP&M Client: Court of Appeals Tells FDA to Regulate Barium Sulfate As a Device

FDA Law Blog

APRIL 19, 2021

Genus Medical Technologies secured an important victory in the D.C. In Genus Medical Technologies v. FDA , the Court of Appeals ruled that FDA cannot regulate a medical product – in this case, the radiographic contrast agent barium sulfate – as a drug when the product meets the definition of a device.

Manufacturing

Manufacturing Government Medical IT

Attorney General Garland: Marijuana Enforcement Remains Low DOJ Enforcement Priority in States Where Activity Is Legal

FDA Law Blog

MAY 2, 2022

Marijuana is legal for medical use in 37 states, and for recreational use by adults in 18 states, but the drug remains a federal schedule I substance. They are the most stringently regulated substances of abuse and it is unlawful to manufacture and distribute them. 15 and 16, 2019). 21 U.S.C. § 812(c)(10). 21 U.S.C. §

Manufacturing

Manufacturing Medical IT Community

An Arm and a Leg: The Prescription Drug Playbook, Part I

Physician's Weekly

JUNE 19, 2025

When Bob changed jobs, the price tag for his daughter’s medication went through the roof. In January of last year, Cole went to a Walgreens in Appleton, Wisconsin, to get refills on the medication he used to control his asthma. Bob’s journey here begins in 2019 — the first day of high school for his daughter, Mary.

Insurance

Insurance IT Board-Certified Medical

Gabapentinoids – Gabapentin and Pregabalin: Tasce Bongiovanni, Donovan Maust and Nisha Iyer

GeriPal

MARCH 2, 2023

AFP 2019 Gabapentin for chronic neuropathic pain in adults. Eric: Any other interesting tidbits or facts that we should know as providers about gabapentin or Lyrica dosing or pharmacology? It’s not a controlled substance medication. Eric: So I heard gabapentin is the 10th most commonly prescribed medication in the US.

Patient-Centered

Patient-Centered IT Healthcare Medical

Direct-to-consumer advertising distorts prescription drugs’ benefits and costs

Common Sense Family Doctor

FEBRUARY 15, 2025

On the surface, this rule aligns with the American Academy of Family Physicians’ policy that information provided in DTCA "should be accurate, balanced, objective, and complete, not false or misleading, and should not promote unhealthy or unsafe practices." Kennedy, Jr.’s s previously stated intention to ban DTCA from television.

Family Physician

Family Physician Manufacturing Family Families

Psilocybin in Serious Illness: James Downar, Ali John Zarrabi and Margaret Ross

GeriPal

MAY 8, 2025

Summary Transcript CME Summary Weve covered psychedelics on the podcast beforefirst in 2019 with Ira Byock, where we explored their potential role in medicine , and then again in 2023 with Stacy Fischer, Brian Anderson, and Theora Cimino, focusing on the reasons to approach psychedelic use in patients with caution. So medication adjustments.

Illness

Illness IT Patient-Centered Patients

CMS Publishes Grab Bag of Proposed Changes to the Medicaid Drug Rebate Program

FDA Law Blog

JUNE 2, 2023

Most are new or revised definitions and administrative changes, but several proposals represent new policies that should be of concern to drug manufacturers. Price Transparency Surveys The MDRP statute requires manufacturers to submit only three prices: average manufacturer price (AMP), best price, and nominal prices.

Manufacturing

Manufacturing Vaccination Government Diagnosis

FDA-Approved Labeling: Is Enough Enough?

FDA Law Blog

AUGUST 21, 2023

Brand drugs, generic drugs, and medical devices alike have all been the target of state failure-to-warn litigation; in a recent case, OTC acetaminophen is the target. Recall that the funds provided under the Prescription Drug User Fee Acts (PDUFA) are not available to support the agency’s efforts related to monograph drugs.)

Manufacturing

Manufacturing Consulting Healthcare Professional Vaccination

DEA Cranks Out Updated Special Surveillance List and Proposed Regulatory Actions

FDA Law Blog

JUNE 10, 2025

Special Surveillance List of Chemicals, Products, Materials and Equipment Used in the Manufacture of Controlled Substances and Listed Chemicals, 90 Fed. We think that the agency will revise and update the list more frequently as clandestine manufacturing trends require. 21 U.S.C. § 21 U.S.C. § 842(a)(11). 23,711 (June 4, 2025).

Specialization

Specialization Manufacturing Electronics PCP

Patient Groups Sue HHS, CMS for 2020 Rule Allowing the Use of Copay Accumulator Programs

FDA Law Blog

SEPTEMBER 8, 2022

Recognizing the problems that high prescription drug costs pose to patient access to medications, many drug manufacturers have created copay assistance programs to help patients afford the copays and deductibles for their medications. These prohibitions are often referred to as copay accumulator adjustment programs.

Insurance

Insurance Patients Manufacturing Patient-Centered

Planning for the End of the COVID-19 Public Health Emergency

FDA Law Blog

OCTOBER 14, 2022

By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — “We still have a problem with COVID. The President’s comments caused us, who work in the medical product industry, to wonder how the federal government officially declares an end to the Covid-19 public health emergency. We’re still doing a lot of work on it.

Medical

Medical Manufacturing Provider Complication

What Does the “Most Favored Nation” Executive Order Mean for Personal Use Imports?

FDA Law Blog

MAY 13, 2025

Section 5 of the May 12 EO states that within 30 days, HHS will communicate MFN price targets to pharmaceutical manufacturers to bring prices for patients in line with comparably developed nations. If significant progress toward MFN is not made, the EO seeks to permit personal importation of less expensive drugs from foreign countries.

Manufacturing

Manufacturing IT Provider Individual

Primary Care Digest

9 Technologies That Will Shape The Future Of Dentistry

Change is Inevitable – Plan Ahead: An Assessment of FDA’s Draft Guidance on Predetermined Change Control Plans for Artificial Intelligence/Machine Learning-Enabled Device Software Functions

Trending Sources

Indeterminate Change: FDA Releases Draft Guidance on Predetermined Change Control Plans for Medical Devices

A Question 30 Years in the Making: Would a Final LDT Rule Withstand Judicial Scrutiny?

Let’s Listen to Patients: FDA Releases Final Guidance on Patient Engagement in the Design and Conduct of Medical Device Clinical Studies

Minnesota Proposes to Reduce Opioid Product Registration Fees Related to Hospitals

510(k) Modernization 2023

Could the Road to an AKS Violation Be Paved with Good Intentions? Pfizer Asks SCOTUS

The Incredible Shrinking Exemption: FDA Final CDS Guidance Would Significantly Narrow the Scope of Exempt Clinical Decision Support Software Under the Cures Act

FDA Issues Unsupported Safety Warning Regarding Surgical Robots for Cancer Treatment

Estimating Risk Associated with Medical Device Malfunctions: FDA’s Warning letter to Medtronic Highlights an Under Appreciated Potential Source of Error in the Estimation

Big Win for HP&M Client: Court of Appeals Tells FDA to Regulate Barium Sulfate As a Device

Attorney General Garland: Marijuana Enforcement Remains Low DOJ Enforcement Priority in States Where Activity Is Legal

An Arm and a Leg: The Prescription Drug Playbook, Part I

Gabapentinoids – Gabapentin and Pregabalin: Tasce Bongiovanni, Donovan Maust and Nisha Iyer

Direct-to-consumer advertising distorts prescription drugs’ benefits and costs

Psilocybin in Serious Illness: James Downar, Ali John Zarrabi and Margaret Ross

CMS Publishes Grab Bag of Proposed Changes to the Medicaid Drug Rebate Program

FDA-Approved Labeling: Is Enough Enough?

DEA Cranks Out Updated Special Surveillance List and Proposed Regulatory Actions

Patient Groups Sue HHS, CMS for 2020 Rule Allowing the Use of Copay Accumulator Programs

Planning for the End of the COVID-19 Public Health Emergency

What Does the “Most Favored Nation” Executive Order Mean for Personal Use Imports?

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