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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FDA Law

OCTOBER 2, 2024

A draft guidance issued last year focused on PCCPs for devices incorporating artificial intelligence and machine learning (AI/ML), which we blogged about here ; this guidance has not yet been finalized. Draft Guidance at 34. Comments on the Draft Guidance may be submitted until November 20, 2024.

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Medical Specialization Manufacturing IT 59

FDA Law

MARCH 31, 2024

House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA) and Subcommittee Chair Brett Guthrie (R-KY), in announcing the hearing, made their views clear: “FDA has proposed a rule that relies upon dubious and misguided legal, economic, and public health arguments and has provided limited opportunities for stakeholders to offer input.

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Patients Medical Provider Manufacturing 64

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.” seeking treatment). This makes seeking clearance of an OTC home test a risky business endeavor.

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

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FDA Law

MAY 3, 2021

We thought this would be a good time to post a series of blog posts focusing on DEA inspections and how registrants should prepare for and manage them, with a list of registrant do’s and don’ts. Part 1 provides background and explains the scope of DEA cyclic and on-site inspections. On Commerce, Manufacturing and Trade of the H.

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Management Manufacturing Specialization IT 40

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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FDA Law

OCTOBER 10, 2022

You can find our preliminary blog post on the release of this guidance here , and our blog posts on the draft CDS guidances here and here. Criterion 3 : Non-Device CDS software functions are intended for the purpose of supporting or providing recommendations about a patient’s care to a health care professional (HCP) user.

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FDA Law

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. For instance, some products could remain in boxes in hospital inventory for an extended period.

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Medical Management Manufacturing Patients 40

FDA Law

MARCH 6, 2025

We were struck by the level of detail expected by FDA for processes related to data management, especially for data collected and used early in development to train an initial AI model, which may occur before a manufacturer decides to move forward with device development under design controls. data acquisition device).

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Manufacturing Management Clinical Practice Clinic 105

FDA Law

SEPTEMBER 28, 2022

Valley Hospital, Inc. 25, 2022), [link] , considered whether a provider’s use of a medical device that is the subject of an FDA safety communication constitutes per se evidence of wanton disregard, which would warrant punitive damages. The New Jersey Punitive Damages Act (PDA) provides that “punitive damages may be awarded.

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Provider Hospital Patients Manufacturing 59

FDA Law

APRIL 8, 2024

For generic drug manufacturing facilities specifically, the numbers are 63% and 87%. MRAP would provide oversight of an accreditation body which would conduct assessments—paid for by the manufacturer—based on criteria developed by the MRAP. In Section I.A,

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FDA Law

SEPTEMBER 30, 2024

CMS did not finalize the price verification survey, which would have required manufacturers of 10 costly drugs selected annually to provide clinical information as well as information on production, distribution, research, and marketing costs, revenue and profit, and ex-U.S. Remarkably, manufacturers may not dispute a CMS notification.

Manufacturing 59

Manufacturing Utilities Provider IT 59

FDA Law

OCTOBER 17, 2023

In October 2022, FDA released the draft guidance entitled “Select Updates for the Breakthrough Devices Program Guidance: Reducing Disparities in Health and Healthcare,” as previously discussed in our blog. FDA will consider if technologies and device features “address unmet needs in these populations” when evaluating criterion one.

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FDA Law

NOVEMBER 22, 2022

Some of us might still recall the 2017 salmonella outbreak linked to raw turkey products that caused over 279 infections, 107 hospitalizations, and one reported death in 41 states. FDA will hold a webinar to provide an in-depth overview of the final rule and Q&A on Dec. 7, 2022 at 1 p.m.

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Supply Chain Illness Family Families 52

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).

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Medical Physicals IT Healthcare Professional 69

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). Basis at 7-8; NPRM at 44,614. Basis at 61; NPRM at 44,615. *

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FDA Law

NOVEMBER 8, 2022

Below, we provide a snapshot of the three-day event: Update on the International Medical Device Regulators Forum (IMDRF). Torres also shared that the eSTAR program, which we most recently blogged about here , is being developed with Health Canada. Maisel also discussed disposition of already distributed devices.

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Medical Manufacturing Patient-Centered Provider 59

FDA Law

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.

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