Manufacturing, Medical and Specialization

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. This image is then relayed to a machine that manufactures the crown right in the office.

Patients

Patients Treatment Plan Healthcare Medical Specialty

The Future Of Vision And Eye Care

The Medical Futurist

JUNE 21, 2025

However, things are moving fast, and success doesn’t come easy for the pioneers of any medical field. Scientists at Columbia University Medical Center and the University of Iowa used CRISPR to repair a genetic mutation responsible for retinitis pigmentosa in induced pluripotent stem cells derived from a patient with the disease.

Diabetes

Diabetes Patient-Centered IT Patients

The Healthcare Vision of ChatGPT-4o and Multimodal LLMs

The Medical Futurist

JUNE 21, 2025

Although this revolution has been brewing for years, the past few months marked a major change , as algorithms finally moved out of the specialized labs and into our daily lives. Current medical AIs only process one type of data, for example, text or X-ray images. However, medicine, by nature, is multimodal as are humans.

Healthcare

Healthcare Healthcare Professional Electronics Medical

It’s the Law Now –Cybersecurity Information in Premarket Submissions

FDA Law Blog

APRIL 25, 2023

Shapiro — Does your firm manufacture a “cyber device”? Congress has given FDA the authority to require device manufacturers to provide cybersecurity information in their premarket submissions for a “cyber device.” Software as a Medical Device, or SaMD) or the software is embedded in a traditional hardware device (i.e.,

Specialization

Specialization Provider Medical Manufacturing

Indeterminate Change: FDA Releases Draft Guidance on Predetermined Change Control Plans for Medical Devices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. FDA, Guidance for Industry, The Special 510(k) Program (2019). By Adrienne R. For 510(k) devices, a PCCP may be submitted only with a traditional or abbreviated application.

Medical

Medical Specialization Manufacturing IT

Change is Inevitable – Plan Ahead: An Assessment of FDA’s Draft Guidance on Predetermined Change Control Plans for Artificial Intelligence/Machine Learning-Enabled Device Software Functions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. Manufacturers should be able to verify and validate the proposed modifications within their existing quality system.

Manufacturing

Manufacturing Provider Medical IT

What is Special about September 24, 2023 for the UDI System?

FDA Law Blog

MARCH 27, 2023

Baumhardt, Senior Medical Device Regulation Expert — The Unique Device Identification (UDI) System final rule requires all medical devices to bear a unique numeric or alphanumeric code in easily readable plain-text and machine-readable form. So, what is special about September 24, 2023? By Philip Won & Lisa M.

Specialization

Specialization Supply Chain Manufacturing Medical

New Draft Guidance Provides Detailed (and Burdensome) Recommendations for Chemical Assessments to Support Medical Device Biocompatibility

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. Chemical characterization can also be useful in evaluating a change to the materials or manufacturing of a device.

Provider

Provider Medical Manufacturing Consulting

Small Change: FDA’s Final Predetermined Change Control Plan (PCCP) Guidance Ditches ML and Adds Some Details, But Otherwise Sticks Closely to the Draft

FDA Law Blog

FEBRUARY 13, 2025

Baumhardt, Principal Medical Device Regulatory Expert FDA recently released its final guidance for Predetermined Change Control Plans (PCCPs) for Artificial Intelligence-Enabled Device Software Functions (AI-DSF).

Manufacturing

Manufacturing Management Specialization Provider

MN Legislative Session 2025: Updates on Health Care Bills

Minnesota Academy of Family Physicians

MARCH 27, 2025

2413 ( Senator Mann ) creates a new assessment on hospitals to increase Medical Assistance reimbursement rates. HOUSE HEALTH COMMITTEE On Wednesday, March 19, 2025, the House Health Committee heard a series of health care bills addressing insurance coverage and medication pricing. This will trigger a special election in District 6.

Family Physician

Family Physician Insurance Finance Individual

Well Isn’t that Special: An Assessment of the Special Control Associated with Simple Point of Care COVID-19 Antigen Tests

FDA Law Blog

MAY 19, 2023

Baumhardt, Senior Medical Device Regulation Expert & Richard A. In this blog we examine the Special Controls put in place to mitigate false results, incorrect interpretation of results, and incorrect operation of the device. analytical, clinical and stability).

Specialization

Specialization Clinic Provider IT

Minnesota Proposes to Reduce Opioid Product Registration Fees Related to Hospitals

FDA Law Blog

JUNE 28, 2021

On June 26, 2021, during the Minnesota legislature’s special session, the Minnesota House of Representatives passed HF33, an omnibus health and human services bill. Whether HF33 is enacted or not, state legislative initiatives aimed at combatting the opioid epidemic continue to be a moving target for opioid manufacturers.

Hospital

Hospital Manufacturing Specialization Medical

Jennifer Newberger Returns to HPM as a Director After Stints with Apple, Abbott Laboratories, and Cognito Therapeutics

FDA Law Blog

MAY 27, 2024

HPM) proudly announces the return of Jennifer Newberger as a Director, further boosting its already robust medical device practice. She also specializes in medical device software and digital health. Hyman, Phelps & McNamara, P.C. Having worked with Jennifer for six years previously, I am truly excited to have her return.

Management

Management Manufacturing Utilities Relationship

Baby Formula Shortages

Georgetown Pediatrics & Family Medicine

MAY 11, 2022

Always mix formula as directed by the manufacturer. If your child is older than 6 months of age and is usually on regular formula (not a specialty product for allergies or other special health needs), this may be an option. Always follow label instructions or those given to you by your pediatrician. Can I make my own baby formula?

Supply Chain

Supply Chain Specialization IT DO

FDA’s Pre-Cert Pilot Ends. Will there be a Sequel?

FDA Law Blog

OCTOBER 31, 2022

Lenz, Principal Medical Device Regulation Expert — FDA began the Software Precertification (Pre-Cert) pilot program in 2017 to evaluate an alternative approach to regulation of software as a medical device (SaMD) over the total product lifecycle (TPLC). By Adrienne R. Key Performance Indicators.

Manufacturing

Manufacturing Specialization Management IT

The New FDA Draft Human Factors Guidance: A Bridge Too Far

FDA Law Blog

FEBRUARY 22, 2023

In 2016 , the agency issued its definitive HF guidance, guide manufacturers through human factors engineering processes during the development of new medical devices, focusing specifically on the user interface. Now FDA has issued a draft guidance , Content of Human Factors Information in Medical Device Marketing Submissions (Dec.

Manufacturing

Manufacturing Engineering Medical IT

ACI’s 43rd FDA Boot Camp – New York City Edition

FDA Law Blog

FEBRUARY 27, 2025

As such, we can offer our readers a special 10% discount. The discount code is: D10-999-FDA25.

Manufacturing

Manufacturing Specialization Clinic Provider

(Slightly More) Options for cGMP for Combination Products: FDA Describes Alternative or Streamlined Mechanisms for Compliance

FDA Law Blog

SEPTEMBER 26, 2022

Lenz, Principal Medical Device Regulation Expert & Holly N. requires generally that manufacturing of a combination product (CP) must comply with the applicable current Good Manufacturing Practice regulations (cGMPs) for all of its components ( i.e., a drug/device CP must follow the cGMPs for drugs as well as those for medical devices).

Manufacturing

Manufacturing Specialization Provider Medical

HP&M Welcomes Senior FDA Official, Ana Loloei, to the Firm

FDA Law Blog

FEBRUARY 19, 2024

Loloei also served as a Senior Policy Advisor in CDRH and as a Special Advisor in the Office of the Commissioner. Loloei is a 14-year veteran of the FDA, where most recently she served as a Senior Regulatory Counsel in the Office of Policy at CDRH. While at FDA, Ms. During her FDA tenure, Ms.

Engineering

Engineering Manufacturing Specialization Management

I Hear You Knockin’… Preparing for and Managing DEA Inspections (Part 1)

FDA Law Blog

MAY 3, 2021

DEA seeks to prevent, detect and eliminate the diversion of controlled pharmaceuticals while ensuring their availability for legitimate medical, scientific and industrial purposes. The CSA establishes classifications for drugs based on their potential for abuse relative to their legitimate medical use. 21 U.S.C. §

Management

Management Manufacturing Specialization IT

FDA Publishes De Novo Classification Final Rule with Few Changes from the Proposed Rule

FDA Law Blog

OCTOBER 25, 2021

The Medical Device Amendments of 1976 created the initial premarket application (PMA) review and 510(k) substantial equivalence review processes. befitted a very important pathway to market for novel medical devices. Shapiro — After 23 years, de novo classification review finally has an implementing regulation ! Part 860.

Manufacturing

Manufacturing Government Specialization IT

Proposed LDT Rule Raises Many Questions but Provides Few Answers

FDA Law Blog

OCTOBER 6, 2023

The crux of the proposed rule lies in the addition of ten words: “ including when the manufacturer of these products is a laboratory.” These words would be added to the definition of “ in vitro diagnostic [IVD] products” in 21 C.F.R. Whether academic medical centers should be treated differently than other laboratories offering LDTs.

Provider

Provider Manufacturing IT Medical

I Hear You Knockin’… Preparing for and Managing DEA Inspections (Part 1)

FDA Law Blog

MAY 3, 2021

DEA seeks to prevent, detect and eliminate the diversion of controlled pharmaceuticals while ensuring their availability for legitimate medical, scientific and industrial purposes. The CSA establishes classifications for drugs based on their potential for abuse relative to their legitimate medical use. 21 U.S.C. §

Management

Management Manufacturing Specialization IT

Get the 4-1-1 on your 1099s: 5th and 7th Circuits Permit Paying Volume-Based Compensation to Independent Sales Agents

FDA Law Blog

MAY 7, 2025

Gonzalez There has been increased enforcement against medical device companies that engage in the pervasive practice of paying third party sales agents based on their volume of sales. In that decision, a medical laboratory paid Marchetti percentage-based compensation for successful referrals of Medicare patients to the laboratory.

Referral

Referral Relationship Government Healthcare

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. They started trying out different medications and dosages. This is gonna be a process.

Insurance

Insurance IT Board-Certified Medical

Does the Drug Shortage White Paper Fall Short?

FDA Law Blog

APRIL 8, 2024

For generic drug manufacturing facilities specifically, the numbers are 63% and 87%. The proposed Manufacturing Resiliency Assessment Program (MRAP) would be managed as a public-private partnership and would assign resilience scores to manufacturers of generic drugs, “based on an assessment of manufacturer practices and past performance.”

Supply Chain

Supply Chain Manufacturing Government Hospital

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

GeriPal

MAY 8, 2025

So in our trial, because of security reasons, we are required by Health Canada to store the substance in a special secure area in my office. Alex 06:03 Is psilocybin that’s used for medicinal purposes in your studies, for example, is that manufactured or is it derived directly from mushrooms? So medication adjustments.

Illness

Illness IT Patient-Centered Patients

DEA Cranks Out Updated Special Surveillance List and Proposed Regulatory Actions

FDA Law Blog

JUNE 10, 2025

DEA publishes the Special Surveillance List to inform about potential illicit uses of a laboratory supply and reminds that civil penalties may be imposed on businesses that distribute a laboratory supply with reckless disregard for the illegal uses to which it will be put. DEA published the original Special Surveillance in May 1999.

Specialization

Specialization Manufacturing Electronics PCP

Aging and Climate Change: Karl Pillemer, Leslie Wharton, & Ruth McDermott-Levy

GeriPal

DECEMBER 7, 2023

I actually wonder though, since we’re on a GeriPal broadcast, I think that people are under emphasizing the special risk of older people. And it is going to affect, if it hasn’t already, our food quality, the food that’s available, our medications. And then for medical education, I know they are doing a lot as well.

Healthcare

Healthcare IT Education Community

STATEMENT RELEASE: Doctors for America’s FDA Task Force Dismayed by Kennedy Testimony

Doctors for America

MAY 15, 2025

Americans are also increasingly unsafe as Kennedy has dismissed technical staff who inspect and ensure safety of facilities manufacturing drugs and goods. DFA is an organization of over 27,000 physician and medical student advocates in all 50 states, representing all areas of specialization.

Medical Student

Medical Student Medical Advice Vaccination Education

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. (We note our departure from more light-hearted content and absence of musical references. Please bear with us.) it is illegal to import.

Manufacturing

Manufacturing IT Individual Provider

“Radical Transparency” and “Deregulation” from Trump and RFK Jr.’s FDA. Unless it’s Useful to the Device Industry

FDA Law Blog

MAY 23, 2025

The classification letters are important because they include the special controls with which all similar devices must demonstrate compliance in a future 510(k) submission. It is necessary that the special controls be made publicly available as soon as possible to enable future manufacturers to use the de novo as a predicate device.

Manufacturing

Manufacturing Specialization IT Provider

Primary Care Digest

9 Technologies That Will Shape The Future Of Dentistry

The Future Of Vision And Eye Care

Trending Sources

The Healthcare Vision of ChatGPT-4o and Multimodal LLMs

It’s the Law Now –Cybersecurity Information in Premarket Submissions

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

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

What is Special about September 24, 2023 for the UDI System?

New Draft Guidance Provides Detailed (and Burdensome) Recommendations for Chemical Assessments to Support Medical Device Biocompatibility

Small Change: FDA’s Final Predetermined Change Control Plan (PCCP) Guidance Ditches ML and Adds Some Details, But Otherwise Sticks Closely to the Draft

MN Legislative Session 2025: Updates on Health Care Bills

Well Isn’t that Special: An Assessment of the Special Control Associated with Simple Point of Care COVID-19 Antigen Tests

Minnesota Proposes to Reduce Opioid Product Registration Fees Related to Hospitals

Jennifer Newberger Returns to HPM as a Director After Stints with Apple, Abbott Laboratories, and Cognito Therapeutics

Baby Formula Shortages

FDA’s Pre-Cert Pilot Ends. Will there be a Sequel?

The New FDA Draft Human Factors Guidance: A Bridge Too Far

ACI’s 43rd FDA Boot Camp – New York City Edition

(Slightly More) Options for cGMP for Combination Products: FDA Describes Alternative or Streamlined Mechanisms for Compliance

HP&M Welcomes Senior FDA Official, Ana Loloei, to the Firm

I Hear You Knockin’… Preparing for and Managing DEA Inspections (Part 1)

FDA Publishes De Novo Classification Final Rule with Few Changes from the Proposed Rule

Proposed LDT Rule Raises Many Questions but Provides Few Answers

I Hear You Knockin’… Preparing for and Managing DEA Inspections (Part 1)

Get the 4-1-1 on your 1099s: 5th and 7th Circuits Permit Paying Volume-Based Compensation to Independent Sales Agents

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

Does the Drug Shortage White Paper Fall Short?

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

DEA Cranks Out Updated Special Surveillance List and Proposed Regulatory Actions

Aging and Climate Change: Karl Pillemer, Leslie Wharton, & Ruth McDermott-Levy

STATEMENT RELEASE: Doctors for America’s FDA Task Force Dismayed by Kennedy Testimony

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

“Radical Transparency” and “Deregulation” from Trump and RFK Jr.’s FDA. Unless it’s Useful to the Device Industry

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