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.

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Diabetes Patient-Centered IT Patients 98

FDA Law Blog

OCTOBER 4, 2022

By Véronique Li, Senior Medical Device Regulation Expert — Allegations of regulatory misconduct are claims that a medical device manufacturer or marketers of medical devices operate in such a way that violates the law.

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Manufacturing Medical Provider IT 52

Plum Health

AUGUST 30, 2024

Everything You Need to Know About Costs and Coverage Patient is inquiring about healthcare. For example, I had a patient who was able to get her Ozempic at a fraction of the cost through Novo Nordisk’s assistance program after her insurance only partially covered the medication. Save with patient assistance programs.

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Primary Care Insurance Diabetes Manufacturing 52

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).

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Medical Manufacturing Healthcare Government 98

The Medical Futurist

JUNE 21, 2025

To diagnose and treat a patient, a healthcare professional listens to the patient, reads their health files, looks at medical images and interprets laboratory results. ” Patient points to lower abdomen. M-LLM (Translating for Specialist): “The patient is pointing to the lower abdomen.”

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Healthcare Healthcare Professional Electronics Medical 53

FDA Law Blog

DECEMBER 12, 2022

If you are a manufacturer of implants that go into the human body for the treatment of disease, it’s an easy yes that you are a manufacturer of a medical device. Manufacturers of software products should determine whether their software functions are excluded from the definition of a device.

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FDA Law Blog

DECEMBER 13, 2022

Although on its face the restriction applies to LDTs, collection device manufacturers could, as a consequence, effectively be precluded from continuing to market their specimen collection devices to labs offering LDTs which enable home collection unless they first obtain authorization specifically for home collection.

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Telehealth Patients Manufacturing Transportation 72

FDA Law Blog

MAY 8, 2023

The discussion paper described a PCCP as including (1) the types of anticipated modifications (SaMD Pre-Specifications or SPS) based on the retraining and model update strategy and (2) the associated methodology (Algorithm Change Protocol or ACP) being used to implement those changes in a controlled manner to manage patient risks.

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CDOCS

AUGUST 11, 2021

.</span></p> <p><span style="font-size:14px;">This patient presented with a chief complaint of his poorly matching crown on tooth #9. This crown has been in service for 10 years, but now the patient would like to replace it for his daughters upcoming wedding (figure 1). .</span></p>

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Manufacturing IT Patients Relationship 52

FDA Law Blog

MAY 29, 2025

Another area for which AI models may be suited in the medical device space would be post-market data, such as Medical Device Reports, where the data submitted is in a more standardized format from manufacturer to manufacturer.

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Manufacturing Patient-Centered Medical Management 102

My Green Doctor

MAY 3, 2025

Innovative surgeries, novel pharmaceuticals, and state of the art technology are just a few of the driving forces that have aided the delivery of exceptional care to patients across all specialties. Dilating and anesthetic eye drops are used routinely to treat patients in most ophthalmology clinics. 3 “Each U.S.

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Medical Supply Chain Hospital Healthcare 52

FDA Law Blog

AUGUST 4, 2022

Pfizer manufactures tafamidis, a breakthrough treatment for a rare, progressive heart condition known as transthyretin amyloid cardiomyopathy. Eligible patients would be responsible for only $35 per month, and Pfizer would cover the rest of the approximately $13,000 annual copay. Background. The Lesson of this Case.

Manufacturing 98

Manufacturing Medical Government IT 98

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 75

Medical Manufacturing Healthcare Government 75

CDOCS

FEBRUARY 14, 2025

These files can be stored alongside other patient records, shared with colleagues, or included in lab orders for streamlined collaboration.& </strong> now allows users to upload bridge case designs to DS Core, enabling centralized management of end-to-end manufacturing tasks. .&

Management 52

Management Manufacturing Patients Specialization 52

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 ).

Patients 52

Patients Clinic Medical Patient-Centered 52

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.

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Manufacturing Hospital Healthcare Medical 81

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.

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Manufacturing Insurance Patients IT 52

FDA Law Blog

JUNE 2, 2025

Those in the lab industry and the physicians and patients who rely upon LDTs are sure to be breathing a well-deserved sigh of relief over this development. Just before this decisive event, though, FDA released a relatively rare Warning Letter to a manufacturer of research use only (RUO) reagents.

IT 64

IT Manufacturing Government Clinic 64

CDOCS

MAY 11, 2019

& Patient presents as an 80 year old woman who was wearing an ill fitting partial for awhile and was losing weight because eating was very difficult. & jpg]</p> <p>So, once the bridge came in from the lab, we had the patient come in. & jpg][image:Untitled_2_012.jpg]</p> jpg][image:Untitled_2_012.jpg]</p>

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FDA Law Blog

NOVEMBER 30, 2022

According to the allegations in the complaint, approval of the new Los Angeles manufacturing facility required a Prior Approval Supplement (PAS) and a Pre-Approval Inspection (PAI) of the facility. 3729) quit tam suit, alleging that Grifols USA, Grifols Biologicals, Grifols, S.A.,

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Manufacturing Government Healthcare Management 72

CDOCS

JUNE 23, 2021

& A core file is then returned to design and manufacture the bridge.& & A core file is then returned to design and manufacture the bridge.& & The patient had an Axeos CBCT Scan and an optical scan with CEREC 5.1.2 In this case, however, the decision was made to have the patient return for new imaging.

Families 52

Families Family Manufacturing Patients 52

CDOCS

JANUARY 12, 2021

It saves dentists time and money while attracting patients and adding valuable services.</p> They currently leverage inLab design software and SprintRay to create as many same-day opportunities for their patients as possible. </p> <p>Drs. </p>

Manufacturing 52

Manufacturing Utilities Patients IT 52

My Green Doctor

MAY 3, 2025

This isn’t just about saving the planet—it’s also about saving money, protecting patients, and strengthening our healthcare systems from the inside out. Dilating and anesthetic eye drops are routinely offered to patients in most ophthalmology clinics. Now, more than ever, they must also become champions of planetary health.

Healthcare 52

Healthcare Healthcare Professional Consulting Management 52

FDA Law Blog

JUNE 27, 2023

James’s status as a 15-year champion for bringing patient voices to the table with FDA and industry decision-makers was also considered. James is recognized as helping fundamentally shift the culture to consider the patient voice as an integral part of drug development.

Management 81

Management Manufacturing Patients Provider 81

FDA Law Blog

DECEMBER 12, 2022

Shapiro — Last summer, FDA published a draft guidance, Laser-Assisted In Situ Keratomileusis (LASIK) Lasers – Patient Labeling Recommendations (July 29, 2022) setting forth a proposal for new recommended patient‑directed labeling. The approved devices already have patient‑directed labeling that FDA has approved. By Jeffrey K.

Manufacturing 52

Manufacturing Provider Patients IT 52

FDA Law Blog

SEPTEMBER 22, 2024

MDR FDA discussed a few preliminary steps that it says laboratories should take prepare for submitting MDRs as medical device manufacturers. SCG : Modified version of another manufacturer’s FDA-authorized test within scope described in preamble to LDT Final Rule. is it the lab itself, the healthcare provider, or the patient?).

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Manufacturing Electronics Provider Management 64

FDA Law Blog

JANUARY 4, 2023

Brevig, Senior Regulatory Device and Biologics Expert — On December 7, 2022, FDA’s Center for Biologics Evaluation and Research (CBER) and the Office of Tissues and Advanced Therapies (OTAT) held a town hall to answer questions related to cell therapy and tissue-engineered products chemistry, manufacturing, and contr­­ols (CMC).

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Manufacturing Engineering Clinic Provider 59

FDA Law Blog

MARCH 8, 2023

Manufacturers who submit reports via the FDA Electronic Submissions Gateway are being advised to update their systems by this time. Since the final rule took effect on August 14, 2015, medical device manufacturers and importers have been required to submit MDRs in an electronic format.

Electronics 59

Electronics Manufacturing Provider Medical 59

FDA Law Blog

JUNE 28, 2021

Under current Minnesota law enacted in May 2019, manufacturers that sell, deliver, or distribute into or within Minnesota 2 million or more units of an opiate are required to pay an annual product registration fee of $250,000. One unit equals one tablet, capsule, patch, syringe, milliliter, or gram.” 151.066, Subd.

Hospital 52

Hospital Manufacturing Specialization Medical 52

FDA Law Blog

NOVEMBER 6, 2022

In its petition filed earlier this month, Pfizer challenges HHS’s interpretation of the AKS as “staggeringly overbroad,” contrary to the congressional intent behind the AKS, and a threat to “almost any activity that facilitates patient access to federally funded healthcare.” Background.

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Manufacturing Patient-Centered Healthcare Utilities 83

FDA Law Blog

SEPTEMBER 29, 2021

The 340B program, authorized under Section 340B of the Public Health Services Act and administered by HRSA, imposes a ceiling price on pharmaceutical manufacturer sales to “covered entities,” which are certain health clinics that receive federal funding and certain types of safety net hospitals to provide them drugs at lower prices.

Manufacturing 52

Manufacturing Government Referral Provider 52

CDOCS

MAY 4, 2021

Without this additional skill set and post graduate training I simply could not deliver the results that my patients deserve. & A healthy 46-year-old patient who has lived for over 30 years with missing bilateral maxillary incisors desired a fixed solution to his problem.

Patient-Centered 52

Patient-Centered Patients Manufacturing Clinic 52

FDA Law Blog

JUNE 16, 2023

Kirschenbaum — On May 24, Minnesota enacted the Commerce and Consumer Protection Omnibus Bill, Senate File 2744 ( SF 2744 ), which significantly expands the state’s existing drug pricing activities with serious implications for all drug manufacturers, and particularly generic drug manufacturers. We address each below. Best price?

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Manufacturing Provider Consulting IT 45

FDA Law Blog

JULY 13, 2022

If a drug that has been approved for 12 years—but less than 16 years—is selected for the Drug Price Negotiation Program, a biosimilar manufacturer can request a one-year moratorium on negotiations for that product so that the biosimilar manufacturer has time to secure licensure and begin marketing of the biosimilar version.

IT 52

IT Manufacturing Utilities Complication 52

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.

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Specialization Provider Medical Manufacturing 105

FDA Law Blog

FEBRUARY 15, 2023

It is expected that, during these instances, patient risk from radiation exposure can be mitigated and minimized. has been modified so that manufacturers of diagnostic x-ray products no longer need to submit initial (§ 1002.10), supplemental (§§ 1002.11), abbreviated (§ 1002.12) and annual reports (§ 1002.13).

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Manufacturing Electronics Medical Clinic 52

FDA Law Blog

OCTOBER 6, 2021

By Faraz Siddiqui — Last week, we blogged about a growing list of drug manufacturers that have refused to follow a 2010 guidance issued by the Health Resources and Services Administration (“HRSA”), which permits 340B covered entities to contract with multiple pharmacies to dispense drugs to covered entity patients. Code Ann.§

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