FDA Law

JANUARY 18, 2022

Cato — On December 10, 2021, FDA issued a discussion paper titled 3D Printing Medical Devices at the Point of Care seeking feedback on FDA regulatory oversight of various 3D-printing scenarios, in order to inform future policy development. products intended for medical purposes). products intended for medical purposes).

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Medical Manufacturing Healthcare Government 75

The Medical Futurist

JUNE 21, 2025

Compared to that, our hearing only processes 11 percent of information, while smell 3.5 However, things are moving fast, and success doesn’t come easy for the pioneers of any medical field. Experts even say the eye is an ideal place to start for the first clinical use of CRISPR. percent, touch 1.5 Renowned scholars, L.D.

Diabetes 105

Diabetes Patient-Centered IT Patients 105

FDA Law

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 ). Valentine & Larry J.

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Patients Clinic Medical Patient-Centered 52

FDA Law

FEBRUARY 7, 2023

Lenz, Principal Medical Device Regulation Expert — For medical device start-up companies, understanding and successfully navigating applicable FDA regulations and requirements is an important part of the path to market. Part 814), and for conducting clinical trials (21 C.F.R. Part 821), medical device reporting (21 C.F.R.

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FDA Law

JULY 23, 2024

Lenz, Principal Medical Device Regulation Expert — For several years, FDA has requested that sponsors of drug or biologic led combination products identify essential performance requirements (EPRs) related to the device constituent in their applications. By Adrienne R. does not use this term. . does not use this term.

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FDA Law

MAY 8, 2023

Baumhardt, Senior Medical Device Regulation Expert & Philip Won & Gail H. In February 2020, FDA granted a de novo classification request (DEN190040) for software intended to assist medical professionals in the acquisition of cardiac ultrasound images and that included a PCCP for future software modifications.

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Manufacturing Provider Medical IT 98

FDA Law

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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Provider Medical Manufacturing Consulting 59

FDA Law

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

OCTOBER 10, 2022

Javitt — On September 28, 2022, the FDA issued the long anticipated final Clinical Decision Support Software Guidance (CDS Guidance), which replaces the revised draft guidance document from 2019. Criterion 2 : Non-Device CDS software functions display, analyze or print medical information about a patient or other medical information.

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Clinic Medical Provider Patients 52

FDA Law

MARCH 3, 2024

Biotechnology services include advising or consulting services related to the use of the above equipment, disease detection, or genealogical information, or any other service for the research, development production, analysis, detection, or provision of information including data storage and transmission related to biological materials.

Manufacturing 102

Manufacturing Government Consulting IT 102

FDA Law

MARCH 8, 2023

By Véronique Li, Senior Medical Device Regulation Expert — On March 17, 2023, enhancements to FDA’s electronic Medical Device Reporting (eMDR) system will go live. Manufacturers who submit reports via the FDA Electronic Submissions Gateway are being advised to update their systems by this time.

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Electronics Manufacturing Provider Medical 59

FDA Law

JUNE 2, 2025

Michael Laposata and the Association for Molecular Pathology in the recent LDT litigation, the Federal, Food, Drug, and Cosmetic Act does not authorize FDA to regulate LDTs as medical devices. Just before this decisive event, though, FDA released a relatively rare Warning Letter to a manufacturer of research use only (RUO) reagents.

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IT Manufacturing Government Clinic 64

FDA Law

DECEMBER 12, 2022

How could the manufacturers even follow this guidance without illegally departing from their previously approved labeling? It looks similar to the type of procedural informed consent a surgeon ordinarily would present to a patient. After reviewing the information. What is going on here? Draft Guidance. Public Comments.

Manufacturing 52

Manufacturing Provider Patients IT 52

FDA Law

FEBRUARY 23, 2025

Manufacturers must evaluate device changes in the first instance to determine whether a new 510(k) is needed or, instead, whether documentation of the change and rationale for not seeking 510(k) clearance is sufficient. Manufacturers should, therefore, welcome any additional source of examples of device changes to aid in evaluating their own.

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Manufacturing Provider Consulting IT 64

FDA Law

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.

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Manufacturing Engineering Medical IT 64

FDA Law

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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Manufacturing Engineering Clinic Patients 45

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

CDOCS

MAY 4, 2021

We need to recognize how clinical dentistry has become intertwined with digital technologies to synergistically assist us in providing enhanced diagnosis with safe and predictable treatment outcomes. & Intra-oral photographs were taken and after reviewing his medical history we discussed his desires for a fixed replacement of these teeth.

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Patient-Centered Patients Manufacturing Provider 52

FDA Law

MARCH 31, 2024

Susan Van Meter, the president of the American Clinical Laboratory Association, said, “FDA is poised to reshape the regulation of laboratories by bypassing Congress and unilaterally imposing medical device regulation on the professional testing services that laboratories provide.” The FDA proposed rule elicited some strong criticism.

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Patients Medical Provider Manufacturing 64

FDA Law

DECEMBER 16, 2024

Lenz, Principal Medical Device Regulation Expert FDA recently released 510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review which finalizes the draft guidance of the same title issued in December 2023. By Adrienne R.

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Consulting Manufacturing Utilities Provider 52

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.

Patient-Centered 52

Patient-Centered Healthcare Manufacturing Provider 52

FDA Law

SEPTEMBER 20, 2021

requesting records in lieu of an inspection, use of information shared by trusted foreign regulatory partners). STAR aims to facilitate earlier access to novel uses of existing therapies for patients with a serious condition with unmet medical needs. Notable Dates and Timelines – Applications open, Q4 of FY 2023.

Patient-Centered 52

Patient-Centered Manufacturing Clinic Provider 52

FDA Law

JANUARY 5, 2025

In discussing these revisions, FDA clarified that an ACNU failure must be reported even if the failure does not cause or lead to inappropriate medication use or consumer harm. The third was the postmarketing requirement for reporting an ACNU failure. Further elaboration of FDAs view would be helpful.

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Provider Healthcare Individual IT 59

FDA Law

MARCH 31, 2022

Last week, CMS issued Manufacturer Release 116 to put flesh on the bones of the new multiple best price option, including details about the structure of VBP arrangements and the respective responsibilities of manufacturers, states, and CMS. The manufacturer will report a best price corresponding to each GNUP. See 42 C.F.R.

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Manufacturing Hospital IT Clinic 40

FDA Law

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.

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Manufacturing Specialization Government IT 52

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? Lastly, I also just want to give a shout out to the last article above which also includes this lovely checklist of methods to address hearing loss in clinical encounters. I’m guessing not. Transcript.

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IT Screening Hospital Clinic 102

FDA Law

MAY 19, 2023

Baumhardt, Senior Medical Device Regulation Expert & Richard A. Final Release Criteria Special Controls Sponsors will need to provide the final manufacturing release criterion with evidence that lots released at the extremes of the specification will still meet the claimed device performance (i.e.,

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Specialization Clinic Provider IT 40

Physician's Weekly

JUNE 18, 2025

Clinical information will be reviewed by a multidisciplinary team of physicians and scientists. This team will prereview all submitted information and then convene for a one-day “tumor board-style” meeting. More Information Copyright © 2025 HealthDay. said in a statement. said in a statement.

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Manufacturing Provider Clinic Medical 52

FDA Law

MARCH 6, 2025

Lenz, Principal Medical Device Regulation Expert & Lisa M. For non-AI-enabled devices, the early feasibility research may not directly affect the development process, i.e., the final, finished device can be fully developed, transferred to a controlled manufacturing environment, and tested under a design controls process.

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Manufacturing Management Clinical Practice Clinic 105

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. §

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Manufacturing Provider Physicals Electronics 64

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. By Philip Won & Lisa M. 360e-3)).”

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Medical Diagnosis Healthcare Clinic 53

FDA Law

JANUARY 8, 2023

The enactment of the Medical Marijuana and Cannabidiol Research Expansion Act (“the Act”) into law (Public Law 117-215) last month is a step in that direction. To date 39 states and the District of Columbia have legalized cannabis for medical use (and 21 for adult recreational use), mainly through ballot initiatives. 21 U.S.C. §

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Medical Manufacturing Electronics Provider 64

The Clinical Problem Solvers

NOVEMBER 6, 2023

Identify ways to navigate clinical interactions with patients while respecting them and affirming their experiences with food and fatness. Natal alienation is, in part, the under-structure of the wider Medical-Industrial Complex and the gratuitous violence that fat, Black, trans folks experience. is rooted in anti-Blackness.

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Community Manufacturing Patients Medical 52

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 This capacity limitation does not apply to OTC lateral flow antigen tests, which can be manufactured in the hundreds of millions per month at a much lower cost than RT?PCR Why is that? Background.

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Screening Manufacturing Healthcare IT 98

FDA Law

OCTOBER 24, 2024

Gibbs — A recent blog post focused on the potentially negative implications of the proposed Patent Eligibility Restoration Act (PERA) for manufacturers of generic drugs and biosimilar products. The concerns raised by PERA are not limited to these industries, however. HPM is currently representing AMP in unrelated litigation.)

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Manufacturing Clinic IT Vaccination 64

FDA Law

JUNE 14, 2023

By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — “Total Product Life Cycle Advisory Program or TAP pilot — the most exciting thing in MDUFA V. While that observation is intended as praise for the TAP Pilot, it can be considered a sad commentary on the general state of manufacturer-CDRH interactions.)

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Manufacturing Medical Appointment Patient-Centered 45

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. So medication adjustments. James 00:32 Good afternoon.

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Illness IT Patient-Centered Patients 107