FDA Law Blog

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 advises clients on complaint handling, MDRs, Quality System Regulation compliance and enforcement matters. In the pre-market area, Ms. In addition, Ms.

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pharmaphorum

OCTOBER 4, 2022

Such non-device CDS are: (1) not intended to acquire, process, or analyse a medical image or a signal from an in vitro diagnostic device or a pattern or signal from a signal acquisition system (Criterion 1); (2) intended for the purpose of displaying, analysing, or printing medical information about a patient or other medical information (e.g.

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FDA Law Blog

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. There is much to unpack, and we intend to do so in a series of blog posts.

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FDA Law Blog

DECEMBER 11, 2023

Mullen — With comments due on the proposed LDT rule last week, FDA wasted no time updating the Unified Agenda to indicate that a final rule may be published in April ( here ). We take this date with a grain of salt given the frequency with which these dates are missed and given the volume of comments filed. (It

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Pharma Business Blog

FEBRUARY 7, 2023

A proposal has been put forward to amend the transitional provisions for certain medical devices and in vitro diagnostic medical devices (amending Regulations (EU) 2017/745 (MDR) 1 and (EU) 2017/746 (IVDR) 2. – The extension is directly applicable, therefore changing the date on the individual certificates is not necessary.

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FDA Law Blog

SEPTEMBER 22, 2024

Prior to February 2, 2026, FDA also said that it does not intend to enforce complaint requirements under 21 CFR 820.198 for developers that are already in compliance with the complaint requirements under ISO 13485. Instead, we focus here on the few notable statements that provide new or more detailed guidance than FDA has previously offered.

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Advarra

MARCH 21, 2023

Regulations for research involving devices, in vitro diagnostics (IVDs), and digital therapeutics differ from those governing pharmaceutical development. In other words, what are the risks and benefits of the product? The greater the risk, the more likely a series of trials for market clearance or approval will be required.

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Advarra

APRIL 19, 2023

In vitro diagnostic (IVD) devices are tests used on human biospecimens (e.g., blood or tumor tissue) to diagnose diseases or other conditions, monitor a person’s health, or help manage a current condition. Although IVDs themselves do not treat, prevent, or cure diseases, the data they output can be an important part of disease management.

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The Pharma Data

OCTOBER 27, 2020

The test is planned for commercial launch as a CE-IVD ( in vitro diagnostic) certified product in the European Union in Q1 2021. 3a will continue to advance its industrial design, product usability, labelling compliance, regulatory approval, and production planning work in parallel to its validation studies. .”

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FDA Law Blog

FEBRUARY 4, 2024

Medical Device Reporting, Quality System Regulation compliance, and reporting of corrections and removals). The joint press release largely repeats, and has CMS endorse, the arguments FDA has previously made in support of its proposed rule, which we rebut in the detailed comments we filed on behalf of a coalition of laboratories.

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FDA Law Blog

DECEMBER 6, 2023

The PRIA also omits entire other categories of costs, such compliance with 21 C.F.R. Javitt — On Monday, Hyman, Phelps & McNamara, P.C. filed comments on behalf of the Coalition to Preserve LDT Access and Innovation in response to FDA’s proposed rule to regulate laboratory developed tests (LDTs) as devices.

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The Pharma Data

MAY 3, 2021

Other articles examined communication – one on persuasive skills, another on disseminating of regulatory intelligence – and the regulatory response to nitrosamine contamination of drug products. . . Continuous professional development. DiMichele provides valuable information on some of the available programs. . .

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Advarra

AUGUST 31, 2022

If a new medical device, software as a medical device (SaMD), or in vitro diagnostic (IVD) is poised to successfully make it through the development process to commercialization, sponsors must consider a trifecta of interconnected systems involving: Regulatory strategy and submissions. Quality assurance and risk management. Intended use.

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Advarra

SEPTEMBER 23, 2022

The Food and Drug Administration (FDA) is the federal entity in the U.S. charged with (among other things) “ensur[ing] that safe and effective drugs are available to improve the health of the people in the United States.” . Whether the drug is safe and effective in its proposed use(s), and whether the benefits of the drug outweigh the risks. .

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Advarra

JULY 18, 2023

Clinical trials involving investigational in vitro diagnostic (IVD) devices are subject to the Food and Drug Administration’s (FDA’s) investigational device exemption (IDE) requirements ( 21 CFR 812 ). When an investigational device does not carry this potential for serious risk, the clinical investigation is NSR.

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XTalks

JUNE 12, 2023

As technology continues to revolutionize every sector of our lives, the medical device industry stands at the forefront of this innovation, playing a pivotal role in enhancing patient care, improving diagnostic accuracy and transforming treatment modalities. Note: When it comes to companies that report in foreign currencies, the conversion to U.S.

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The Pharma Data

NOVEMBER 4, 2020

CENTOGENE’s SARS-CoV-2 test is a molecular diagnostic test performed for the in vitro qualitative detection of RNA from the SARS-CoV-2 in oropharyngeal samples from presymptomatic patients and probands according to the recommended testing by public health authority guidelines. CAMBRIDGE, Mass. and ROSTOCK, Germany and BERLIN, Nov.

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FDA Law Blog

OCTOBER 10, 2022

As a refresher, the Cures Act established the following four criteria for Non-Device CDS software: Criterion 1 : Non-Device CDS software functions do not acquire, process, or analyze medical images, signals from an in vitro diagnostic (IVD) device, or patterns or signals from a signal acquisition system.

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Cloudbyz

AUGUST 19, 2024

Compliance with their regulations is mandatory for manufacturers seeking to market their devices globally. European Medicines Agency (EMA): Regulates medical devices within the European Union through the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). What is the Medical Device Safety process?

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FDA Law Blog

JULY 7, 2024

The first phaseout milestone is less than a year away; by May 6, 2025 most laboratories will need to demonstrate compliance with Medical Device Reporting (21 C.F.R. § 803), Reporting of Corrections and Removals (21 C.F.R. § 806) and Complaint Files (21 C.F.R.

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FDA Law Blog

AUGUST 3, 2022

If anything, the announcement was remarkably inconspicuous: a seemingly throwaway sentence in a draft compliance policy guide for research use only and investigational use only products. These products are subject to the same regulatory requirements as any unapproved medical device”).

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XTalks

JUNE 30, 2023

Sartorius is a globally recognized player in the diagnostics industry, providing a variety of solutions for in vitro diagnostics kit (IVD) manufacturers. But to meet aggressive milestones and stringent performance standards, there’s a need for continuous innovation and streamlined development and quality control workflows.

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pharmaphorum

AUGUST 4, 2022

If not internally, such specialist training programmes can be outsourced to third-party organisations, whether that involves pharmaceuticals, in vitro diagnostics (IVDs) or QP training. This has resulted in staff and talent shortages, meaning that industries have been forced to respond quickly to stay afloat. Harness technology.

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The Pharma Data

JANUARY 16, 2021

It has become the de facto standard equipment for high titer transient protein expression platforms used by many leading Chinese antibody drug pharmaceutical companies and IVD (In Vitro Diagnostics) companies since its launch in Oct. Etta Biotech is a leading cell electroporation technology and equipment supplier. JS Bio’s parent company.

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Roots Analysis

OCTOBER 19, 2023

Bacteria plays a crucial role in maintaining the ecosystem balance. However, there are few species of bacteria that can cause several infectious diseases ( such as strep throat, salmonellosis, tuberculosis, whooping cough ). These are mainly transmitted through air, water, living organisms, and food.

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The Pharma Data

MARCH 17, 2021

Overall, patient compliance for PROs was greater than 90 percent. The PRO analysis included patients in both arms of the study and measured their experiences with side effects, symptoms, and health-related quality of life, in those receiving Verzenio plus ET versus ET alone. The detailed data were presented at the virtual 17th St.

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Pharmaceutical Technology

NOVEMBER 22, 2022

mRNA vaccines can be made more quickly than traditional vaccine platforms because they are produced using an in vitro synthetic process that does not require the time-consuming growth or removal of cells and proteins. Before COVID-19, Merck held the record for the fastest modern vaccine ever developed. The UK Government is behind this effort.

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The Pharma Data

NOVEMBER 17, 2021

Streamlined in vitro data, published in bioRxiv, demonstrate that sotrovimab retains exertion against all current variants of concern and interest of the SARS-CoV-2 contagion as defined by the World Health Organization, plus others, including, but not limited to, Delta (B.1.617.2), 1.617.2), Delta Plus (AY.1 2) and Mu (B.1.621).

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FDA Law Blog

FEBRUARY 23, 2025

By Steven J. Gonzalez & Allyson B. Mullen As the device industry is well aware, one of the greyest areas in device regulation (of which there are many) is determining when changes to a 510(k)-cleared device trigger the need for a new clearance. See 21 C.F.R. But this guidance has its limitations.

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FDA Law Blog

FEBRUARY 20, 2025

Citing the May 6 compliance date for Stage 1 of the LDT Rule, both ACLA and AMP asked that Judge Jordan issue his ruling expeditiously. Many of the fired employees were within the Center for Devices and Radiological Healththe Center that is tasked with regulating all devices, including in vitro diagnostics, which FDA argues includes LDTs.

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