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. The CDS Guidance interprets the Cures Act’s definition of “medical software” that is excluded from the statutory “device” definition, as it relates to CDS software.

Clinic 52

Clinic Medical Provider Patients 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.

Referral 59

Referral Relationship Government Healthcare 59

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. FDCA § 513(f)(5).

Manufacturing 52

Manufacturing Specialization Government IT 52

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 52

Management Manufacturing Specialization IT 52

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

MARCH 20, 2022

Baumhardt, Senior Medical Device Regulation Expert & Anne K. Almost all recalls are conducted on a voluntary basis by the manufacturer. FDA maintains a database for recalls of FDA-regulated products based on information gathered from press releases and other public notices. “It By Philip Won & Lisa M.

Electronics 40

Electronics Manufacturing Provider IT 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

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

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. Related Stories Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions Congratulations to HP&M’s first Principal Medical Device Regulation Expert, Adrienne Lenz.

Manufacturing 52

Manufacturing IT Government Medical 52

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

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

JANUARY 3, 2022

Unlike March 2020, numerous tests by multiple manufacturers have been reviewed by FDA and are being distributed. Javitt — As we approach our third year of COVID, one of the major questions from March 2020 eerily echoes today: where are all the COVID tests? Mistakes cannot be glossed over.

Manufacturing 52

Manufacturing IT Government Patients 52

GeriPal

DECEMBER 7, 2023

So if you look at government websites about heat for example, it’s got a line of buttons across the top with affected populations, outdoor workers, athletes and older people are in there. And it is going to affect, if it hasn’t already, our food quality, the food that’s available, our medications. Ruth: Right.

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Healthcare IT Education Hospital 129

Tiny Physician

OCTOBER 17, 2021

The Kerala government has taken off all the restrictions imposed due to the case surge as caseload has come down, and is also planning to restart schools from the second half of November. Indian Medical Association (IMA) Kerala wing criticized the minister at that time as the medicine lacked scientific evidence (2). References 1.

Vaccination 52

Vaccination Government Physicals IT 52

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

JUNE 1, 2025

Commissioner Makary has taken a more subdued stance, stating in a podcast with Megyn Kelly that FDA doesnt have any plans to ban direct-to-consumer advertising, but there are some things that we can do to make sure that the information being presented is a complete picture. In 2021, the U.S.

Healthcare Professional 59

Healthcare Professional Manufacturing Healthcare Utilities 59

FDA Law

MAY 23, 2025

Newberger Last week, FDA published a Request for Information (RFI) ( here ) seeking input from the public on its efforts to to identify and eliminate outdated or unnecessary regulations. It is therefore surprising that nearly a month or more has passed for four of these five de novos without any information being posted. By Allyson B.

Manufacturing 59

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. Information related to the importation (e.g., See 21 C.F.R. 251.5; § 251.6(c).

Supply Chain 59

Supply Chain Manufacturing Chronic Condition Government 59

Physicians News Digest

APRIL 2, 2025

By Julie Appleby Tim Winard knew he needed to buy health insurance when he left his management job in manufacturing to launch his own business. The Medical Procedure Periodic colon cancer screening is recommended for people at average risk starting at age 45 and continuing until age 75, according to the U.S. Then the bill came.

Insurance 52

Insurance Screening Hospital Patient-Centered 52

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).

Manufacturing 59

Manufacturing Provider Medical IT 59