2016, Manufacturing, Patients 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. For patients, it promises more accurate care and better outcomes. How about having a teledentist consultation?

Patients

Patients Treatment Plan Healthcare Medical Specialty

The Future Of Vision And Eye Care

The Medical Futurist

JUNE 21, 2025

The California-based firm, Second Sight , the German company, Retina Implant AG, and the French venture, Pixium Vision were the forerunners of the field, developing implantable visual prosthetics to restore vision to patients who are blind as a result of the rare condition of retinitis pigmentosa.

Diabetes

Diabetes Patient-Centered IT Patients

FDA Publishes Discussion Paper Seeking Feedback on 3D Printing of Medical Devices at the Point of Care

FDA Law Blog

JANUARY 18, 2022

In October 2014, FDA held a public workshop titled “Additive Manufacturing of Medical Devices: An Interactive Discussion on the Technical Considerations of 3D Printing.” Specifically, that it allows for fast production of “patient-matched devices” (i.e., use in education, construction, art, and jewelry).

Medical

Medical Manufacturing Healthcare Government

New Draft Guidance Provides Detailed (and Burdensome) Recommendations for Chemical Assessments to Support Medical Device Biocompatibility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

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.” By Philip Won & Jeffrey K. It applies whether the software is the entire device (i.e.,

Specialization

Specialization Provider Medical Manufacturing

FDA Publishes Discussion Paper Seeking Feedback on 3D Printing of Medical Devices at the Point of Care

FDA Law Blog

JANUARY 18, 2022

In October 2014, FDA held a public workshop titled “Additive Manufacturing of Medical Devices: An Interactive Discussion on the Technical Considerations of 3D Printing.” Specifically, that it allows for fast production of “patient-matched devices” (i.e., use in education, construction, art, and jewelry).

Medical

Medical Manufacturing Healthcare Government

Recent Developments in the Medicaid Drug Rebate Program

FDA Law Blog

MAY 31, 2021

PhRMA Sues CMS Challenging MDRP Rule Curbing Patient Assistance. Manufacturers provide patient savings programs at the pharmacy counter to defray the patient’s out-of-pocket costs such as co-pays and deductibles. In December 2020, CMS published a final rule making several changes to the MDRP regulations.

Manufacturing

Manufacturing Insurance Patients IT

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

FDA Law Blog

NOVEMBER 1, 2023

Regulating LDTs: A Long and Winding Road In what might sound to some like protesting too much, the PR invokes FDA’s longstanding assertion that IVDs “manufactured” by laboratories are medical devices and that clinical laboratories that develop tests are acting as manufacturers.

Manufacturing

Manufacturing Hospital Healthcare Medical

Answers to the Most Frequently Asked Questions about the Previous Answers to the Most Frequently Asked Questions about Charging for Investigational Drugs

FDA Law Blog

SEPTEMBER 6, 2022

This Draft Guidance, when finalized, will replace the Final Guidance issued just six years ago (the 2016 Guidance). Changes from the 2016 Guidance. What’s new in the new Draft Guidance? Not all that much. The new Q & As (Q21, Q22, and Q23) all concern charging in the context of expanded access.

Clinic

Clinic Manufacturing Patients 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. Consider this scenario: A manufacturer files a 510(k) for a Class II device, a surgical mask.

Manufacturing

Manufacturing Engineering Medical IT

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

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. 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

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. Some products may move with high velocity to patient use. A December 2021 warning letter to Medtronic, Inc.

Medical

Medical Management Manufacturing Patients

It Takes Three [Components] to Make a Thing Go Riiiiiight – OPDP Challenges Two-Part Ad

FDA Law Blog

JANUARY 26, 2022

Component 1 was a disease state component – identified as “The Journey Forward: Ryan Murphy” or “The Journey Forward: Allysa Seely.” (Note that Allysa Seely is a Paralympian gold medal triathlete, and swimmer Ryan Murphy is a 2016 Olympian and gold medalist.)

IT

IT Education Utilities Patient-Centered

Joint Basis for FDA/HHS Marijuana Rescheduling Recommendation Unveiled

FDA Law Blog

JANUARY 18, 2024

FDA conducted the eight-factor scheduling analysis required by the CSA in 2016 and found that marijuana continued to meet the scheduling criteria for remaining in schedule I. 12, 2016); Denial of Petition to Initiate Proceedings to Reschedule Marijuana, 81 Fed. Denial of Petition to Initiate Proceedings to Reschedule Marijuana, 81 Fed.

Medical

Medical Physicals IT Healthcare Professional

DEA Concurs: Marijuana Meets Schedule III Criteria

FDA Law Blog

MAY 5, 2024

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. Schedule III substances do not require manufacturing quotas. 53,688 (Aug.

Medical

Medical Manufacturing Physicals Healthcare Professional

A Review of H5N1

Alabama Academy of Family Physicians

FEBRUARY 20, 2025

Since 2016, HPAI H5N1 has been detected in wild birds in the United States during screening efforts by wildlife authorities. Also, CDC has provided a candidate vaccine virus to manufacturers for rapid production if needed. Several commercial laboratories are providing this service including Quest, LabCorp, ARUP and Mayo.

Patient-Centered

Patient-Centered Provider Manufacturing Screening

Buckle Up: DOJ Initiates Rulemaking to Reschedule Marijuana

FDA Law Blog

MAY 21, 2024

We wondered how given that HHS and the Drug Enforcement Administration (“DEA”) conducted eight-factor scheduling analyses in 2016, concluding that there was “no substantial evidence that marijuana should be removed from Schedule I.” 12, 2016) ; Denial of Petition to Initiate Proceedings to reschedule Marijuana, 81 Fed. 12, 2016).

Physicals

Physicals Medical Clinic Emergency Room

Drug Pricing Reform Gathers Steam (Part 2)

FDA Law Blog

SEPTEMBER 14, 2021

The MFP would be established through negotiations between HHS and the manufacturer and would incorporate foreign pricing benchmarks, as further described below. In order to permit MFPs to be negotiated under Part D, the current prohibition on Medicare negotiating with manufacturers would be repealed. 8126 with a lower MFP.

Manufacturing

Manufacturing Insurance Government Patients

Senator Durbin Has Questions About FDA’s “Operational Capacity” to Oversee DTC Prescription Drug Advertising Amid Workforce Reductions – Don’t We All?

FDA Law Blog

JUNE 1, 2025

Government Accountability Office (GAO) published a report finding that, for the years 2016-2018, the pharmaceutical industry spent on average for a sample of 553 drug products approximately $6 billion annually on DTC advertisements, with a significant portion of this spending allocated to television commercials. In 2021, the U.S.

Healthcare Professional

Healthcare Professional Manufacturing Healthcare Utilities

MedTech Conference Download

FDA Law Blog

NOVEMBER 8, 2022

Below, we provide a snapshot of the three-day event: Update on the International Medical Device Regulators Forum (IMDRF). To paraphrase from our blog post , EUAs are triggered by an EUA declaration; FDA will publish advanced notice for an EUA declaration and provide a 180 day notice before the implementation of the transition plan.

Medical

Medical Manufacturing Patient-Centered Provider

Drug Pricing Reform Gathers Steam (Part 1): White House Drug Pricing Plan Offers Laundry List of Existing Democrat Priorities

FDA Law Blog

SEPTEMBER 13, 2021

A final OIG rule to change the structure of manufacturer rebates to Medicare Part D and Medicaid Managed Care plans and their PBMs is enmeshed in litigation and is likely to be at least postponed until 2026 (see our post ), and perhaps prevented from implementation altogether, by Congressional mandate.

Manufacturing

Manufacturing Supply Chain Patient-Centered Utilities

Primary Care Digest

9 Technologies That Will Shape The Future Of Dentistry

The Future Of Vision And Eye Care

Trending Sources

FDA Publishes Discussion Paper Seeking Feedback on 3D Printing of Medical Devices at the Point of Care

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

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

FDA Publishes Discussion Paper Seeking Feedback on 3D Printing of Medical Devices at the Point of Care

Recent Developments in the Medicaid Drug Rebate Program

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

Answers to the Most Frequently Asked Questions about the Previous Answers to the Most Frequently Asked Questions about Charging for Investigational Drugs

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

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

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

It Takes Three [Components] to Make a Thing Go Riiiiiight – OPDP Challenges Two-Part Ad

Joint Basis for FDA/HHS Marijuana Rescheduling Recommendation Unveiled

DEA Concurs: Marijuana Meets Schedule III Criteria

A Review of H5N1

Buckle Up: DOJ Initiates Rulemaking to Reschedule Marijuana

Drug Pricing Reform Gathers Steam (Part 2)

Senator Durbin Has Questions About FDA’s “Operational Capacity” to Oversee DTC Prescription Drug Advertising Amid Workforce Reductions – Don’t We All?

MedTech Conference Download

Drug Pricing Reform Gathers Steam (Part 1): White House Drug Pricing Plan Offers Laundry List of Existing Democrat Priorities

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