The Medical Futurist

JUNE 21, 2025

Researchers say that the implant cannot provide any highly detailed vision – but it can help patients detect distinct patterns such as door frames and shapes. However, things are moving fast, and success doesn’t come easy for the pioneers of any medical field.

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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.

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My Green Doctor

MAY 3, 2025

In This Issue : Why Renewable Energy Belongs in Every Clinic Medical Waste: One Model for Improvement OnTrack with your Sustainability Goals? Powering Health, Protecting the Planet – Why Renewable Energy Belongs in Every Clinic Healthcare professionals have always been trusted voices on public health.

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Healthcare Healthcare Professional Consulting Management 52

Plum Health

AUGUST 30, 2024

Mike to discuss affordable GLP-1 medication! These are groundbreaking medications that not only help regulate blood sugar but also support weight loss. Ozempic is classified as a glucagon-like peptide-1 ( GLP-1) agonist , a type of medication that imitates the actions of a gut hormone known as GLP-1.

Primary Care 52

Primary Care Insurance Diabetes Manufacturing 52

FDA Law Blog

MARCH 24, 2024

By Faraz Siddiqui — As drug manufacturers battle the Health Resources and Services Administration (“HRSA”) in federal courts over the role of 340B contract pharmacies, an Eighth Circuit decision to uphold a 2021 Arkansas law may render those cases inconsequential in that state. Code Ann. § 23-92-604(c)(1), (2) (Act 1103).

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FDA Law Blog

NOVEMBER 29, 2023

Focused and Bounded This guiding principle recommends that the PCCP describe a specific planned change that is consistent with the claimed intended use and intended purpose of the Machine Learning Medical Device (MLMD). The plan should identify the methods for verifying and validating the change.

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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.,

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Specialization Provider Medical Manufacturing 105

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. Change to the IVD definition First, the mechanics of the change.

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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.

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FDA Law Blog

SEPTEMBER 22, 2024

Instead, we focus here on the few notable statements that provide new or more detailed guidance than FDA has previously offered. MDR FDA discussed a few preliminary steps that it says laboratories should take prepare for submitting MDRs as medical device manufacturers. By Steven J. Gonzalez & Lisa M.

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FDA Law Blog

JANUARY 5, 2022

Lenz has become its first Principal Medical Device Regulation Expert. She has also held positions in regulatory affairs, quality assurance, and test engineering at GE Healthcare and Smiths Medical. Hyman, Phelps & McNamara, P.C. (HP&M) HP&M) is pleased to announce Adrienne R. Adrienne joined HPM in September 2017.

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FDA Law Blog

JANUARY 5, 2022

Lenz has become its first Principal Medical Device Regulation Expert. She has also held positions in regulatory affairs, quality assurance, and test engineering at GE Healthcare and Smiths Medical. Hyman, Phelps & McNamara, P.C. (HP&M) HP&M) is pleased to announce Adrienne R. Adrienne joined HPM in September 2017.

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Medical Consulting Engineering Manufacturing 40

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

JANUARY 5, 2023

Claud — As we turn into the New Year, we offer a few items of interest in digital and telehealth regulation, enforcement, and compliance that may provide some helpful guideposts for stakeholders. Combination products are sharing the digital moment with those classified solely as medical devices. By John W.M.

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Manufacturing Patient-Centered Provider Telehealth 59

FDA Law Blog

SEPTEMBER 19, 2023

The six-page statement explains that “Brand drug manufacturers may be harming generic competition through the improper listing of patents in the. And FDA did not provide a substantive response to 5 Requests for Advisory Opinions seeking clarification of the issue. 5429, the “ Medication Affordability and Patent Integrity Act.”

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Manufacturing Provider IT Healthcare 105

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.

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Patients Clinic Medical Patient-Centered 52

FDA Law Blog

APRIL 4, 2023

By Philip Won — South Korea has made significant achievements over the years in the biohealth industry, establishing the world’s second-largest biopharmaceutical manufacturing capacity. South Korean President Yoon Suk Yeol plans to provide full support to create a Korean version of the Boston Biotech Cluster.

Healthcare 52

Healthcare Manufacturing Government Provider 52

FDA Law Blog

AUGUST 23, 2022

Baumhardt, Senior Medical Device Regulation Expert & Richard A. After two negative tests, you should consider a molecular test, or call your healthcare provider. If the third test is negative, you should test again with an antigen test, or get a laboratory molecular-based test, or call your healthcare provider.

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Individual Clinic Healthcare Provider 97

FDA Law Blog

NOVEMBER 16, 2021

Baumhardt , MS, MJ, MT(ASCP), RAC, FRAPS, has joined the firm as a Senior Medical Device Regulation Expert, and that Sophia Gaulkin has joined the firm as an Associate. Baumhardt provides counsel to medical device, in vitro diagnostic, and combination product manufacturers on a wide range of pre- and post-marketing regulatory topics.

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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. Physicians had ultimate control and exercised independent judgment over their patients healthcare decisions. Walsh & Sophia R. Mallory , 988 F.3d

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FDA Law Blog

SEPTEMBER 29, 2023

For more than 30 years, FDA has asserted that it has jurisdiction to regulate LDTs as medical devices and clinical laboratories as manufacturers. The proposed rule has a 60-day comment period for stakeholders. This proposed rule is a long-time coming.

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FDA Law Blog

DECEMBER 12, 2022

How could the manufacturers even follow this guidance without illegally departing from their previously approved labeling? In an appendix, FDA provides a model “decision check list” for patients. You should place your initials in the location provided next to each item to indicate that you have read and understood the item.

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Manufacturing Provider Patients Medical 52

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.

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Patient-Centered Healthcare Manufacturing Provider 52

FDA Law Blog

JUNE 22, 2023

Most recently, Jeff Shuren, CDRH Director, gave a speech at the 2023 Food and Drug Law Institute (FDLI) annual conference in which he identified facilitating “availability of and access to existing and novel home-use medical technologies” as a strategic priority for 2022-2023 to advance health equity. seeking treatment).

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Manufacturing Clinic IT Medical 59

FDA Law Blog

JANUARY 5, 2025

In response to the proposed rule, approximately 200 comments were submitted to the docket, and a meeting took place among FDA, the White House Office of Management and Budget (OMB) and the Consumer Healthcare Products Association (CHPA). The third was the postmarketing requirement for reporting an ACNU failure.

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Provider Healthcare Individual IT 59

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

JULY 5, 2023

Outsourcing facilities are not exempt from FDA’s cGMP for drug manufacturers (as lightly tweaked via cGMP Guidance for outsourcing facilities ) or adverse event reporting requirements , and are subject to regular inspection by FDA. Section II at 2. Draft Guidance III.B.2(f) 2(f) at 9-10.

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FDA Law Blog

AUGUST 7, 2023

By Véronique Li, Senior Medical Device Regulation Expert — The Center for Devices and Radiological Health (CDRH) offers learning opportunities for new and experienced CDRH staff through the Experiential Learning Program (ELP). One noticeable difference from years past is the option for virtual site visits.

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Patient-Centered Manufacturing Insurance Provider 40

FDA Law Blog

OCTOBER 12, 2022

Most states have some form of naloxone standing order that allows a healthcare provider to write a prescription that covers a large group of people rather than just an individual patient. For example, the Maryland standing order allows all Maryland licensed pharmacists to dispense naloxone, including any necessary sup??

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Supply Chain Individual Provider Patient-Centered 52

FDA Law Blog

OCTOBER 10, 2023

By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — As we recently blogged , FDA released three draft guidance documents to help enhance the predictability, consistency, and transparency of the 510(k) program. We find that this information is noteworthy for manufacturers to consider.

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FDA Law Blog

AUGUST 8, 2024

Governors, state cannabis regulators, law enforcement groups and local governments weighed in, as did marijuana advocates and opponents, marijuana industry associations, Members of Congress, federal law enforcement groups, healthcare and human rights groups, unions and trade associations, and private individuals. 21 U.S.C. § 812(c)(c)(10).

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GeriPal

JUNE 20, 2024

Accreditation In support of improving patient care, UCSF Office of CME is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.

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Physician's Practice

JUNE 9, 2025

a health care attorney with Roetzel & Andress, joins the show to explore the legal risks of prescribing GLP-1 medications. Conclusion and Closing Remarks (00:25:02)** Thanking the guest, closing the episode, and providing subscription information. Practice tip of the week: Leading a medical practice Keith A. Adler, J.D.,

Management 52

Management Telemedicine Patients Insurance 52

GeriPal

MAY 5, 2022

COVID-19, masks, and hearing difficulty: Perspectives of healthcare providers. Association of Sensory and Cognitive Impairment With Healthcare Utilization and Cost in Older Adults. And nurses and other healthcare practitioners knew nothing about it. Over-the-counter hearing aids: What will it mean for older Americans?

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IT Screening Hospital Clinic 102

FDA Law Blog

NOVEMBER 18, 2021

Rapid tests for COVID-19 are fast, inexpensive to manufacture, and a relatively easy method to detect the presence of an active SARS?CoV?2 True, these tests will never provide the same diagnostic quality results as RT?PCR, PCR tests, but they provide a testing option better suited for mass screening. Why is that? Background.

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GeriPal

MARCH 2, 2023

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. Eric: Are these generic? Nisha: Both of them are generic, yeah.

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FDA Law Blog

JULY 7, 2024

Laboratories struggling to understand the myriad implications of being regulated as device “manufacturers” were hopeful that additional guidance would shed light on how to apply FDA’s existing medical device regulatory framework to their operations. 803), Reporting of Corrections and Removals (21 C.F.R. §

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