FDA Law

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.” The discussion paper provides an overview of FDA’s current approach to regulation of 3D-printed devices. use in education, construction, art, and jewelry).

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Medical Manufacturing Healthcare Government 75

FDA Law

NOVEMBER 20, 2024

Chemical characterization can also be useful in evaluating a change to the materials or manufacturing of a device. The draft guidance provides recommendations for collection and reporting of chemical characterization data and discusses the topics of information gathering, test article extraction, chemical analysis, and data reporting.

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Provider Medical Manufacturing Consulting 59

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. The journal Nature provided a commentary report on HKUST’s research into the bionic eye. The paper, recently published in PLOS , summarises three years of data.

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Diabetes Patient-Centered IT Patients 105

FDA Law

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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Provider Manufacturing IT Medical 64

FDA Law

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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FDA Law

NOVEMBER 29, 2023

The evidence used to measure the device’s performance should be scientifically and clinically justified, consistent with the level of risk for the proposed change. Transparency This guiding principle calls for manufacturers to be transparent with users regarding the device performance before and after the implementation of the change.

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FDA Law

AUGUST 23, 2022

The 80% sensitivity requirement for antigen tests has yet to be explained either scientifically or clinically by the Agency. After two negative tests, you should consider a molecular test, or call your healthcare provider. It is clearly rooted in fear that less sensitive tests may have too many false negatives.

Individual 97

Individual Clinic Healthcare Provider 97

FDA Law

FEBRUARY 28, 2022

The Agency’s goal is demonstrated in its definition of patient engagement: “Patient engagement is defined as intentional, meaningful interactions with patients that provide opportunities for mutual learning, and effective collaborations.” .

Patients 52

Patients Clinic Medical Patient-Centered 52

FDA Law

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.

Manufacturing 105

Manufacturing Provider IT Healthcare 105

FDA Law

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. These LDTs are performed in clinical laboratories regulated under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). This proposed rule is a long-time coming.

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FDA Law

OCTOBER 14, 2021

Rather, FDA seems intent on regulating RAS devices almost as if they were therapeutics responsible for long term clinical outcomes. It is well out of bounds for FDA to regulate them as if they were a determinant of long term clinical outcomes. We support FDA’s general efforts to inform healthcare providers and protect patient safety.

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Patient-Centered Healthcare Manufacturing Provider 52

FDA Law

JUNE 22, 2023

He also identified “Next-Generation Home-based Testing Technologies, including new IVDs, Digital Lateral Flow Readers, and Reporting Technologies” as an opportunity to “extend care from the hospital and clinic into the home setting.” lay users). seeking treatment). seeking treatment). HbA1c, diagnosis of a particular virus, etc.).

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Manufacturing Clinic IT Transportation 59

FDA Law

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. Digital providers and manufacturers not only have the concerns of the FDA to consider, but those of the FTC as well. By John W.M.

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Manufacturing Patient-Centered Provider Telehealth 59

FDA Law

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.

Telehealth 72

Telehealth Patients Manufacturing Transportation 72

FDA Law

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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FDA Law

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

OCTOBER 10, 2023

Testing should be in line with the device’s intended duration of implantation, but FDA may consider whether testing results for a shorter duration can be extrapolated to provide information about long-term performance. We find that this information is noteworthy for manufacturers to consider.

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Manufacturing Engineering Clinic Provider 45

FDA Law

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). Further elaboration of FDAs view would be helpful.

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Provider Healthcare Individual Manufacturing 59

FDA Law

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(e) Draft Guidance III.B.2(d)

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Supply Chain Manufacturing Physicals Healthcare 52

FDA Law

NOVEMBER 16, 2021

Baumhardt provides counsel to medical device, in vitro diagnostic, and combination product manufacturers on a wide range of pre- and post-marketing regulatory topics. 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.

Medical 40

Medical Healthcare Manufacturing Management 40

FDA Law

AUGUST 7, 2023

Through ELP, CDRH staff visit sites that provide formal training and enhance understanding on topics such as how products are developed and how they fit into the larger healthcare system. The visits are intended purely to provide a training perspective, and not for CDRH staff to opine on any regulatory functions.

Patient-Centered 40

Patient-Centered Manufacturing Insurance Provider 40

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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IT Patient-Centered Patients Clinic 120

FDA Law

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??

Supply Chain 52

Supply Chain Individual Provider Patient-Centered 52

FDA Law

SEPTEMBER 15, 2022

FDA indicates that this guidance is intended to help manufacturers ensure consistent content and format of the statement of identity and strength for all nonprescription drug products, which then will allow consumers to compare products. For both draft guidances, it is unclear what induced FDA to publish these draft guidances now.

Manufacturing 45

Manufacturing Hypertension IT Provider 45

GeriPal

MAY 5, 2022

Was there any mention about the impact that hearing loss has in communication or what we should do about it in clinical practice? COVID-19, masks, and hearing difficulty: Perspectives of healthcare providers. Association of Sensory and Cognitive Impairment With Healthcare Utilization and Cost in Older Adults. Transcript.

IT 102

IT Screening Hospital Clinic 102

FDA Law

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.

Screening 98

Screening Manufacturing Healthcare IT 98

FDA Law

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. § 806) and Complaint Files (21 C.F.R.

Manufacturing 64

Manufacturing Provider Physicals Electronics 64

GeriPal

MARCH 2, 2023

Eric: Any other interesting tidbits or facts that we should know as providers about gabapentin or Lyrica dosing or pharmacology? And for that reason, there was actually an enormous lawsuit, and the manufacturer was fined, now I think 20 years ago, in the millions and millions of dollars for off-label prescribing. Tasce: Right.

Patient-Centered 96

Patient-Centered IT Healthcare Medical 96

FDA Law

OCTOBER 17, 2023

Compared to the previous version, the new guidance document highlights that the Breakthrough Devices Program may also be applicable to certain devices that benefit populations impacted by health and/or healthcare disparities and to certain non-addictive medical products to treat pain or addiction.

Medical 53

Medical Diagnosis Healthcare Clinic 53

FDA Law

JUNE 14, 2023

He highlighted the following key features of TAP: An Innovative Approach To provide proactive support and guidance to medical device manufacturers, FDA has introduced a new CDRH position known as the “TAP Advisor.” The task force facilitates communication between device manufacturers and payors.

Manufacturing 45

Manufacturing Medical Appointment Patient-Centered 45

FDA Law

MAY 5, 2024

OASH concluded “there is widespread current experience with medical use in the United States” by licensed healthcare providers for which “such medical use is recognized by entities that regulate the practice of medicine in these states.” Schedule III substances do not require manufacturing quotas. Single Convention, Arts.

Medical 95

Medical Manufacturing Physicals Healthcare Professional 95

GeriPal

MARCH 24, 2022

Susan: I’ll just say, I think that could happen outside of the healthcare setting pretty easily and frequently does. So it’s an example of something that can start outside of the healthcare system and move its way in. Eric: Anybody else’s thoughts on that? I think Bob also noted documenting it. Rebecca: Agreed.

Illness 72

Illness IT Healthcare Patient-Centered 72

FDA Law

JANUARY 18, 2024

whether growing or not; its seeds; resin extracted from any part; and every compound, manufacture, salt, derivative, mixture, or preparation of the plant, its seeds or resin. “Marijuana,” subject to the rescheduling recommendation, means all parts of the plant Cannabis sativa L., 21 U.S.C. § 802(16)(A). 21 U.S.C. § 802(16)(B).

Medical 69

Medical Physicals IT Healthcare Professional 69

GeriPal

MAY 8, 2025

We’ll discuss three recent clinical trials involving patients with serious illness, joined by our guests James Downar , Ali John Zarrabi , and Margaret Ross. Alex 00:33 Our next guest is Margaret Ross, who’s a clinical psychologist and researcher at St. Ali John 24:35 In clinical trials. James 00:32 Good afternoon.

Illness 107

Illness IT Patient-Centered Patients 107

GeriPal

DECEMBER 7, 2023

AlexSmithMD Additional links: JAMA paper on clinical research risks, climate change, and health Geriatric medicine in the era of climate change Health Care Without Harm: [link] Practice Green Health: [link] Global Consortium for Climate and Health Education: [link] Transcript Eric: Welcome to the GeriPal podcast. Ruth: Yeah. Ruth: Yeah.

Healthcare 129

Healthcare IT Education Hospital 129

FDA Law

MAY 21, 2024

The Attorney General also released DOJ’s Office of Legal Counsel (“OLC”) opinions providing the rationale and support for the NPRM. Schedules of Controlled Substances: Rescheduling of Marijuana, 89 Fed. 44,597 (May 21, 2024). NPRM at 44,607. Basis at 7-8; NPRM at 44,614. Basis at 61; NPRM at 44,615. Basis at 61; NPRM at 44,615. *

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Physicals Medical Clinic Emergency Room 69

FDA Law

JUNE 1, 2025

The bill would also mandate that drug manufacturers report payments to influencers to the federal Open Payments database, similar to current requirements for physicians. This year is shaping up a bit differently with all four OPDP enforcement letters addressing healthcare professional materials (including a speaker slide deck!!).

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Healthcare Professional Manufacturing Healthcare Utilities 59