Dot Compliance

FEBRUARY 8, 2022

SaMD Regulatory and Compliance Challenges. SaMD presents challenges in the regulatory and compliance arena, given the rapid rate of innovation and its effects on the already expansive selection of existing and potential future SaMD solutions. QMS as Critical for SaMD Compliance.

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FDA Compliance 52

Dot Compliance

JANUARY 14, 2022

There are many risk management regulations and compliance standards in the life sciences industry that must be followed to successfully maintain business operations and ensure the safety of staff and product users. EU MDR 2017/745. FDA’s Safer Technologies Program (SteP) for Medical Devices. Source: [link]. Source: [link].

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Compliance FDA Regulatory Compliance Governance 52

Exeed Regulatory Compliance

MARCH 5, 2020

FDA Guidance on EUA, Jan 2017 *Notes: Section 564 as in the Food, Drug and Cosmetic (FD&C Act); PAHPRA refers to the Pandemic and All-Hazards Preparedness Reauthorization Act of 2015 One area of current concern is the lack of diagnostic testing capability in the US to rapidly detect and confirm new cases.

US Department of Health and Human Services 52

US Department of Health and Human Services FDA Public Health COVID-19 52

HIT Consultant

MAY 9, 2022

With mountains of paperwork generated every year, achieving complete patient privacy and 100 percent compliance can be difficult. PDF security features like encryption and redaction can help healthcare organizations achieve greater levels of compliance. The PDF format also integrates easily into EHR platforms.

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FDA COVID-19 Public Health Compliance 98

SQA

JUNE 10, 2021

183/2017, which provides the procedures to obtain the Brazilian Good Manufacturing Practices (BGMP) Certification for medical devices. The CDSCO has postponed deadlines for regulating implantable devices and other medical products for which manufacturers or importers have already applied for licenses under the Medical Device Rules 2017.

FDA 52

FDA COVID-19 COVID-19 Vaccine Compliance 52

Healthcare IT News - Telehealth

AUGUST 19, 2020

In 2017, AccessHealth set goals that were modeled after the Department of Health and Human Service’s Healthy People 2020 Program. Currently, there is a 96% overall compliance rate. A few metrics staff measures that can be quantified are: Percentage of patients with HbA1C blood glucose level of 9% or below.

COVID-19 171

COVID-19 Telemedicine Compliance HIPAA 171

Innovaare Compliance

MARCH 1, 2022

Since 2017, benchmarks have been rising and in 2019, Medicare spent $321 more per person for MA enrollees than it would have spent for the same beneficiaries under traditional Medicare fee-for-service (FFS). 3] The bid is prepared from credible baseline pricing data.

Medicare 52

Medicare Medicare Overpayments Overpayment 52

SQA

FEBRUARY 15, 2023

Of interest is a reference to the FDA’s draft document “Computer Software Assurance for Production and Quality System Software,” which was recently published on 13 September 2022. PCPC looks forward to working with the FDA and key stakeholders to implement this important legislation.

US Department of Health and Human Services 40

US Department of Health and Human Services FDA COVID-19 World Health 40

Bill of Health

APRIL 4, 2024

Beyond the health care sector-specific Medical Devices Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR), this mix of AI & Data related regulatory requirements stems from a series of generalized, cross-sectoral EU laws of the last 5 years. Sectoral US Laws In the U.S.,

FDA 282

FDA Regulatory Compliance Malpractice Health Insurance 282

Healthcare IT News - Telehealth

DECEMBER 16, 2020

The virtual trial, to be sure, is not a new concept: One team of researchers counted more than 1,100 trials listed on ClinicalTrials.gov employing connected digital products for remote data collection in both 2017 and 2018, the organization observed. ” The FDA is hinting that some of these changes could be here to stay.

COVID-19 207

COVID-19 Hospitals Doctors Health Insurance 207

SQA

AUGUST 8, 2023

Personal Care Products Council (PCPC) PCPC MoCRA Toolkit, May 2023 Enacted in December 2022, the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) represents years of efforts by the Personal Care Products Council, the FDA, Congress, and other stakeholders to modernize the U.S. cosmetic regulatory framework.

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FDA Compliance COVID-19 World Health 40

Dot Compliance

DECEMBER 7, 2022

Dot Compliance eQMS Essential Elements 5. Ensuring Compliance with ISO 9001, EU MDR, FDA & More 6. To comply with FDA, EU MDR, and ISO regulatory requirements and lower audit risks and outcomes, more and more firms are relying on a QMS. Dot Compliance eQMS Essential Elements. The Bottom Line. QMS Timeline.

FDA 52

FDA Compliance Records Management 52

SQA

DECEMBER 16, 2022

China’s Center for Medical Device Evaluation (CMDE) Update Compliance Guidelines and Recommended Paths for Clinical Evaluation Paths for Certain Medical Devices, 25 July 2022. 29 of 2022 , Technical Guidelines for Compliance with the Essential Principles of Medical Device Safety and Performance. CMDE Announcement No.

FDA 40

FDA Compliance COVID-19 Licensing 40

Health Law Advisor

JULY 11, 2023

Word Embeddings If you’re one of my three regular readers, you might remember that I’ve already introduced word embeddings I trained on FDA records. In February 2023, I wrote a post on using NLP to assess FDA’s compliance with notice and comment in guidance development. [1] Instead, I’m going to look for bias in other topics.

FDA 40

FDA Hospitals Compliance 40

SQA

OCTOBER 18, 2023

The US FDA has already recognized the ability of 16 EU Member States to conduct GMP inspections of manufacturers of veterinary medicinal products. At the same time, the EU has recognized the US FDA as an equivalent authority to carry out these inspections. As a result, the patient received 2.5

FDA 40

FDA Compliance Licensing World Health 40

SQA

MAY 24, 2023

MDCG 2023-3 , Questions and Answers on Vigilance Terms and Concepts as Outlined in the Regulation (EU) 2017/745 on Medical Devices, provides additional information on key vigilance terms. PCPC’s current priority is to work with the FDA to effectively implement the Modernization of Cosmetics Regulation Act of 2022.

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FDA Licensing Governance Compliance 40

Dot Compliance

FEBRUARY 1, 2022

Food and Drug Administration (FDA) recently issued pharma industry guidance documents that will impact how companies collect, manage and submit quality data to the agency. The post Future Trends and Regulatory Challenges in Pharma appeared first on Dot Compliance. Data in the regulatory spotlight. References. References. References.

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FDA COVID-19 Vaccine Pharmaceutical Industry COVID-19 52

SQA

DECEMBER 10, 2021

Brazil’s New UDI Requirements for Medical Devices: Compliance Implications for Manufacturers, 02 August 2021. UDI compliance lead times for manufacturers will depend on the risk classification of their devices: Two years for Class IV (highest risk) devices. By Laurel Hacche & Debra Cortner SQA Associates. European Commission (EC).

FDA 52

FDA Compliance Public Health Hospitals 52

HIT Consultant

MAY 31, 2023

Common industry practice today allows small groups of large, powerful pharmaceutical manufacturers to drive new drugs through regulatory processes, acting as the gatekeepers to achieve FDA approval. In 2017, only four companies were responsible for 50% of generic pharmaceutical drug production. million Americans.

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Pharmaceutical Industry Hospitals FDA Telemedicine 96

Health Law Advisor

FEBRUARY 1, 2022

The United States Food and Drug Administration (FDA) for many years has been trying to increase the participation of minorities in clinical trials to help ensure that regulated products are tested and labeled in an appropriate cross-section of Americans. National Library of Medicine, with support from FDA.

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FDA Compliance 52

SQA

APRIL 12, 2023

The ISPE APQ Guide: Cultural Excellence is the fifth and final guide in the series that seeks to improve the state of pharmaceutical quality and ensure sustainable compliance. Solid polymer products (such as acrylics) for CAD/CAM work, and thermoplastic or photo-curing resins used in additive processes, are not covered by this document.

FDA 40

FDA Compliance Pharmaceutical Industry 40

AIHC

JANUARY 28, 2022

For more information on filing compliance cost reports, attend the Medicare Cost Report Camp in March 2022 presented by KraftCPAs and sponsored by the American Institute of Healthcare Compliance. This is to allow eligible antimicrobial products to begin receiving the new technology add-on payment sooner. billion in FY 2021, or 2.7

Medicare 52

Medicare Medicare Hospitals Payment Systems 52

The Digital Health Corner

MARCH 26, 2018

As an implanting and following physician who weathered multiple large and clinically critical recalls and alerts over decades (including ones which changed FDA compliance regulations related to them), I can attest to my own records having been more accurate than those of vendors.

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FDA Compliance Medicare Medicare 117

Healthcare Law Blog

OCTOBER 25, 2023

iii] The Act also authorizes the CT DCP to impose penalties for instances of non-compliance or violations of the Act. 2017 Nevada Laws Ch. vii] Violations can be subject to a penalty of $1,000 to $3,000 per violation, where each day that an individual is in violation of this law constitutes a separate violation. ix] Nevada. viii] Id.

Licensing 52

Licensing Compliance FDA Public Health 52

SQA

JULY 8, 2022

Food and Drug Administration (FDA) and product manufacturers are aware that it may be present in food and drug products at trace levels, and those very low levels do not pose a safety concern for consumers. Benzene is a chemical that is ubiquitous in the environment and not an intentionally added ingredient in personal care products.

Pharmaceutical Industry 40

Pharmaceutical Industry FDA Hospitals World Health 40

SQA

AUGUST 2, 2021

ISO 18562-1:2017, Biocompatibility evaluation of breathing gas pathways in healthcare applications – Part 1: Evaluation and testing within a risk management process. ISO 22316:2017, Security and resilience – Organizational resilience – Principles and attributes. United States FDA – Guidances for Devices. b) and 320.31(d)(3)).

FDA 83

FDA COVID-19 Pharmaceutical Industry Hospitals 83

Healthcare IT Today

APRIL 24, 2023

Yet, from 2013-2017, 78% of the drugs approved by the FDA had only one dose regimen and of the drugs considered to be amenable to response-guided treatment, only 39% provided relevant dose instructions. Hakim was awarded an OBE in 2017 for his services to Healthcare Technology and the Economy.

Health Outcomes 75

Health Outcomes COVID-19 FDA Compliance 75

Hall Render

JANUARY 28, 2022

FDA halts use of antibody drugs that don’t work vs. omicron. Where Hospital Price Transparency Compliance Is Lagging. FDA finalizes two guidances on including patient perspectives in medtech clinical trials. Wisconsin Sees First County-Owned SNF Close in the State Since 2017. New COVID-19 cases, deaths fall in Wisconsin.

Nursing Homes 40

Nursing Homes COVID-19 US Department of Health and Human Services Nurses 40

Health Law Advisor

MAY 3, 2022

We have just gone through an extraordinary two years where, in unprecedented fashion, FDA’s inspection process was essentially shut down. Further, from a warning letter standpoint, without inspection data, FDA focused in other compliance realms than it typically might. Just a short while ago FDA recommenced inspections.

FDA 52

FDA Compliance 52

Drug & Device Law

SEPTEMBER 21, 2023

The parties’ contract required the supplier to deliver components that “meet FDA standards for medical devices.” The manufacturer claimed that the supplier breached the contract when it delivered components that, according to the manufacturer, violated the FDA’s Current Good Manufacturing Practices (CGMP) regulations. Ohio 2023).

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FDA Governance Compliance 59

Drug & Device Law

DECEMBER 29, 2023

Since the FDA requires pre-approval of any warnings about off-label uses, preemption at some point should have been pre-ordained under the Mensing ( 2011+1 ) independence principle, but off-label use did not really figure in Zofran ’s analysis. The FDA’s five reviews of teratogenic risk all came to the same conclusion.

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FDA US Department of Health and Human Services COVID-19 Informed Consent 105

Drug & Device Law

OCTOBER 27, 2022

640.65, an FDA biologics regulation that requires entities that collect blood via a particular method to establish “donor identification system[s]” that “positively identifies each donor and relates such donor directly to his blood and its components as well as to his accumulated records and laboratory data.”. 2017), aff’d sub nom.

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FDA Licensing Compliance 59

Drug & Device Law

FEBRUARY 15, 2024

As the DDL blog has previously reported , Michigan’s longstanding presumption of non-defectiveness applicable to FDA-approved drugs was recently repealed by the Michigan legislature in S.B. As this provision is newly applicable to FDA-approved products, it has not been tested by the courts on this issue. Cartridge Co. , 804, 813 (E.D.

FDA 52

FDA Compliance Fraud Hospitals 52

Drug & Device Law

SEPTEMBER 12, 2022

As with practically all post- Albrecht successful preemption cases, the drug had an extensive FDA regulatory history regarding the risk at issue (suicide) and related risks (chiefly depression and suicidal ideation). Preemption turns on the availability of the FDA’s changes being accepted (“CBE”) regulation, 21 C.F.R.

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FDA Compliance 59

Drug & Device Law

MARCH 19, 2024

Plaintiff’s primary allegation is that the clips have a migration rate higher than what was reported to the FDA. Since the clips are PMA, the first prong is met—PMA devices have specific FDA requirements. Plaintiff did not allege that the design of the clips deviated from the FDA approved design.

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FDA Fraud Doctors Governance 52

Drug & Device Law

MAY 5, 2022

2022), a short decision that came out the right way, but did so based on a problematic statute that creates a rebuttal presumption that warning labels approved by the FDA are adequate as a matter of state law. Stated differently, the rebuttal provision makes allegations and evidence of fraud on the FDA a prerequisite to state-law liability.

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Compliance FDA Fraud 52

Drug & Device Law

JULY 26, 2023

Hrymoc has a lot of “one-off” flavor about it, as it was tried under North Carolina law in late 2017. In these states, product liability claims are brought as negligence actions based on the reasonableness of a defendant’s conduct, and a defendant’s compliance with applicable governmental standards is typically relevant evidence.

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Compliance FDA Licensing Governance 52