FDA Law

MARCH 3, 2024

This proposed legislation should be of interest to any biotechnology companies that want to do business with the federal government in the future. Scope Part 2 —Is reimbursement under Medicaid a grant of funds by the federal government, such that they are governed by the Act? House of Representatives ( H.B.

Manufacturing 102

Manufacturing Government Consulting IT 102

FDA Law

FEBRUARY 13, 2025

Baumhardt, Principal Medical Device Regulatory Expert FDA recently released its final guidance for Predetermined Change Control Plans (PCCPs) for Artificial Intelligence-Enabled Device Software Functions (AI-DSF).

Manufacturing 71

Manufacturing Management Specialization Provider 71

FDA Law

AUGUST 15, 2021

Shapiro — A determination of “intended use” is fundamental to FDA’s regulation of drugs and medical devices. FDA has now issued a final rule governing how intended use of a distributed product is to be determined. label use if the manufacturer knew about it. The proposal to delete this provision made sense , because the off?label

Manufacturing 93

Manufacturing IT Provider Government 93

FDA Law

NOVEMBER 15, 2022

By Véronique Li, Senior Medical Device Regulation Expert & Philip Won — In our last blog post , we advised medical device companies to consider applying to FDA’s Small Business Program to help with the noticeably higher user fees for FY2023. In this blog post, we provide a primer on user fees and the Small Business Program.

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Medical Provider IT Manufacturing 59

FDA Law

JUNE 2, 2025

Mullen At midnight on Friday, May 30, 2025, the governments deadline to notice an appeal from the U.S. District Court for the Eastern District of Texass decision vacating the LDT Rule lapsed without the government doing so. Greater scrutiny of RUO products and those companies that manufacture them could be one of those doors.

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IT Manufacturing Government Clinic 64

FDA Law

NOVEMBER 6, 2022

Gaulkin — We previously blogged about Pfizer’s copay assistance lawsuit, which sought to challenge HHS’s interpretation of the Federal health care program anti-kickback statute (AKS) and position that the company’s proposed copay assistance program would violate the AKS. By Sophia R. Background.

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Manufacturing Patient-Centered Healthcare Utilities 83

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. Only a year later, in 1977, FDA promulgated regulations governing 510(k) reviews (21 C.F.R. befitted a very important pathway to market for novel medical devices. Part 860.

Manufacturing 52

Manufacturing Specialization Government IT 52

FDA Law

APRIL 19, 2021

We have blogged recently about several FDA setbacks in court ( here , for example). Genus Medical Technologies secured an important victory in the D.C. In Genus Medical Technologies v. The decision has wide-ranging implications for FDA’s assertion of discretion in classifying and regulating medical products.

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Manufacturing Government Medical IT 40

FDA Law

MAY 3, 2021

Recent Department of Justice (“DOJ”) press releases continue to show evidence of reported registrant civil settlements with the Government alleging recordkeeping and reporting deficiencies. The CSA establishes classifications for drugs based on their potential for abuse relative to their legitimate medical use. 21 U.S.C. §

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Management Manufacturing Specialization IT 52

FDA Law

JANUARY 5, 2023

In mid-November, FDA collaborated with the MITRE Corporation to publish an update to the Medical Device Cybersecurity Regional Incident Preparedness and Response Playbook. Combination products are sharing the digital moment with those classified solely as medical devices.

Manufacturing 59

Manufacturing Patient-Centered Provider Telehealth 59

FDA Law

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 Korea continues to drive the effort in the biohealth industry, which will lead to more Korean players in the U.S.

Healthcare 52

Healthcare Manufacturing Government Provider 52

FDA Law

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. In that decision, a medical laboratory paid Marchetti percentage-based compensation for successful referrals of Medicare patients to the laboratory.

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Referral Relationship Government Healthcare 59

FDA Law

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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Government Medical IT Manufacturing 59

FDA Law

FEBRUARY 5, 2024

HP&M has been helping clients navigate the challenges of state licensing regulations for drugs, biologics, medical devices, OTCs, 503B outsourcing facilities, 503A pharmacies, foods, dietary supplements, cannabis, and wholesalers/distributors for many years.

Consulting 45

Consulting Manufacturing Government Provider 45

FDA Law

MAY 3, 2021

Recent Department of Justice (“DOJ”) press releases continue to show evidence of reported registrant civil settlements with the Government alleging recordkeeping and reporting deficiencies. The CSA establishes classifications for drugs based on their potential for abuse relative to their legitimate medical use. 21 U.S.C. §

Management 40

Management Manufacturing Specialization IT 40

FDA Law

OCTOBER 10, 2022

The CDS Guidance interprets the “medical software” carve-out of the 21st Century Cures Act (2016) as it pertains to Clinical Decision Support (CDS) software functions. Specifically, the guidance interprets the Cures Act’s four criteria for exclusion of CDS software functions from FDA’s medical device jurisdiction (so-called “Non-Device CDS”).

Clinic 52

Clinic Medical Provider Patients 52

FDA Law

MARCH 20, 2022

Baumhardt, Senior Medical Device Regulation Expert & Anne K. Almost all recalls are conducted on a voluntary basis by the manufacturer. Most FDA-regulated entities have an established SOP that governs the evaluation, decision, notification, and process for conducting a recall. By Philip Won & Lisa M.

Electronics 40

Electronics Manufacturing Provider IT 40

FDA Law

AUGUST 17, 2022

This is important because self-fitting hearing aids require the submission and clearance of a 510(k) while regular OTC hearing aids do not, which provides incentive for manufacturers to self-classify their hearing aid products as regular OTC rather than self-fitting. (FYI, The preemption provisions, for example, have not changed.

Provider 40

Provider Manufacturing IT Government 40

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.

Manufacturing 105

Manufacturing Management Clinical Practice Clinic 105

FDA Law

AUGUST 3, 2022

3, 1992) (“It has come to the attention of FDA that laboratories have been manufacturing, “home brew” products, either from products already on the market, or from components, and utilizing these unapproved products for diagnostic purposes. These products are subject to the same regulatory requirements as any unapproved medical device”).

Lab Testing 98

Lab Testing Government IT Manufacturing 98

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.

Medical 53

Medical Diagnosis Healthcare Clinic 53

FDA Law

APRIL 8, 2024

For generic drug manufacturing facilities specifically, the numbers are 63% and 87%. The proposed Manufacturing Resiliency Assessment Program (MRAP) would be managed as a public-private partnership and would assign resilience scores to manufacturers of generic drugs, “based on an assessment of manufacturer practices and past performance.”

Supply Chain 59

Supply Chain Manufacturing Government Hospital 59

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.

Screening 98

Screening Manufacturing Healthcare IT 98

FDA Law

JANUARY 3, 2022

Unlike March 2020, numerous tests by multiple manufacturers have been reviewed by FDA and are being distributed. As we’ve blogged about on many occasions ( see, e.g. , link , link , link , link ), FDA’s LDT policy has been fraught for decades, and the consequences of unresolved jurisdictional issues were made manifest during the pandemic.

Manufacturing 52

Manufacturing IT Government Medical 52

FDA Law

JANUARY 3, 2022

Unlike March 2020, numerous tests by multiple manufacturers have been reviewed by FDA and are being distributed. As we’ve blogged about on many occasions ( see, e.g. , link , link , link , link ), FDA’s LDT policy has been fraught for decades, and the consequences of unresolved jurisdictional issues were made manifest during the pandemic.

Manufacturing 52

Manufacturing IT Government Patients 52

FDA Law

JUNE 2, 2023

Kirschenbaum — Last Friday, May 26, CMS published in the Federal Register an assortment of proposals to change the regulations governing the Medicaid Drug Rebate Program. Most are new or revised definitions and administrative changes, but several proposals represent new policies that should be of concern to drug manufacturers.

Manufacturing 59

Manufacturing Vaccination Government Diagnosis 59

FDA Law

JUNE 4, 2025

Ordinarily, a public health initiative of such magnitude would have been governed by a transparent multi-step process featuring public meetings and drawing on external scientific expertise. In other words, as you read this, the Assessments findings and recommendations are getting baked into federal government policy, for better or worse.

Chronic Disease 59

Chronic Disease Government Chronic Condition Clinic 59

FDA Law

AUGUST 14, 2022

The negotiations will result in a Maximum Fair Price (“MFP”) that the manufacturer must make available to providers furnishing the drug under Medicare Part B or pharmacies dispensing the drug under Part D.

Manufacturing 98

Manufacturing Government Vaccination Utilities 98

FDA Law

JANUARY 24, 2024

That’s a pretty lofty API manufacturing goal, but one that the API Innovation Center (“APIIC”) was charged to take up, consider, and propose some possible solutions. Industry should leverage existing technologies while furthering research and development of innovative and disruptive technologies, in partnership with academia and government.

Supply Chain 69

Supply Chain Manufacturing Government Provider 69

FDA Law

APRIL 21, 2021

In support of this proposal, the Notice looked only to FDA’s publicly available device adverse event database, FDA’s Manufacturer and User Facility Device Experience (MAUDE), to identify any safety risks. Glove manufacturers affected by the exemption should beware of the likely reinstatement of the 510(k) requirements.

Manufacturing 40

Manufacturing Government IT Consulting 40

FDA Law

FEBRUARY 20, 2025

Given the numerous changes in policy by the Trump administration, there had been much speculation that the government would now take a different position on this Biden-era rule. In contrast, AMP and ACLA both asserted that the rule would harm medical care. Perhaps most notable in yesterdays argument, though, was what didnt happen.

Patient-Centered 102

Patient-Centered Consulting Government Clinic 102

FDA Law

OCTOBER 14, 2022

By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — “We still have a problem with COVID. The President’s comments caused us, who work in the medical product industry, to wonder how the federal government officially declares an end to the Covid-19 public health emergency. But the pandemic is over.

Medical 98

Medical Manufacturing Provider Complication 98

FDA Law

JUNE 1, 2025

Government Accountability Office (GAO) published a report finding that, for the years 2016-2018, the pharmaceutical industry spent on average for a sample of 553 drug products approximately $6 billion annually on DTC advertisements, with a significant portion of this spending allocated to television commercials. In 2021, the U.S.

Healthcare Professional 59

Healthcare Professional Manufacturing Healthcare Utilities 59

FDA Law

MAY 8, 2025

Claud On May 6, 2025, FDA announced that it planned to conduct more surprise inspections at foreign manufacturing facilities that produce foods, essential medicines, and other medical products intended for U.S. Walsh & Esther Petrikovsky & John W.M. is safe, legitimate, and honestly made. In a recent Executive Order (E.O.)

Manufacturing 59

Manufacturing Government Physicals IT 59

FDA Law

MAY 23, 2025

During the first Trump Administration, the 10-for-1 Rule seemed to be more in name only when it came to FDA, whereas this administration seems more intent on its deregulatory approach, so we expect it to have more of an impact on FDA governance this time around. Radical Transparency. Deregulation Efforts.

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Manufacturing Specialization IT Provider 59

FDA Law

JANUARY 9, 2024

This request must provide details about, among other things: The foreign seller that will purchase the prescription drug directly from its manufacturer, along with invoices, batch, and lot/control numbers to verify the sale and the units sold. The government would require at least another 30 days to examine the shipment at the U.S.

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Supply Chain Manufacturing Chronic Condition Government 59

FDA Law

MAY 26, 2025

Even if otherwise truthful, the promotion of off-label uses of hormones-including through informal campaigns like those conducted by sales reps or under the guise of sponsored continuing medical education courses-run afoul of the FDAs prohibitions on misbranding and mislabeling. Driehaus , 573 U.S. 149, 158 (2014). 116(e) (emphasis added).

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