Healthcare IT Today

JUNE 7, 2023

DSI and Predictive Models ONC is clearly attempting to leverage its certification program to help the Food and Drug Administration (FDA) increase transparency related to decision alerts, but this seems to be an inefficient and burdensome application of the certification lever.

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Dot Compliance

APRIL 12, 2022

Then we will provide general guidelines for producing labels that will benefit your customers and meet regulatory obligations. The FDA definition of a medical device is something that diagnoses, cures, treats, or prevents a disease or health condition, or otherwise alters the structure or function of the body. US FDA Requirements.

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Exeed Regulatory Compliance

MARCH 21, 2020

Industry is rapidly developing novel coronavirus diagnostic tests for emergency use authorization by the FDA. According to a recent Science Magazine article , South Korea tested more than 270,000 people, which amounts to about 5200 tests per million! More than 250,000 cases of infection and over 10,000 deaths have been reported.

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HIT Consultant

DECEMBER 18, 2023

In this article, we look at the evolution of surgical supply documentation tools – and in particular, assess the current transition from traditional 1D linear barcodes to 2D. There is pressure on healthcare providers to capture full, timely and accurate consumption data to achieve regulatory compliance.

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Exeed Regulatory Compliance

MARCH 5, 2020

It rapidly caused a widespread epidemic in China and has spread to over 50 countries outside of China with more than 90,000 confirmed cases and 3000 deaths at the time of this blog article. There is now an FDA policy released on 29 Feb. New cases are also being reported in the United States and several deaths have been confirmed.

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Exeed Regulatory Compliance

APRIL 6, 2020

Recently, the FDA has authorized the emergency use of the Battelle CCDS Critical Care Decontamination System , which uses vapor phase hydrogen peroxide to decontaminate N95 or N95-equivalent respirators for reuse by healthcare personnel. This is one of the criteria used by the FDA for granting the Emergency Use Authorization.

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SQA

OCTOBER 18, 2022

Policymakers, regulators, and legislators should not make any decisions that impact consumers’ access to FDA-approved sunscreen UV filters until the scientific community reaches an informed consensus. Import, Advertising and Supply Compliance Priorities 2022 to 2023, 12 July 2022. PDA Technical Report No.

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

Exeed Regulatory Compliance

FEBRUARY 24, 2020

References ISO 14971 – Application of Risk Management to Medical Devices , December 2019 MeDRA – Medical Dictionary for Regulatory Activities You may also like these articles 27 Billion Reasons to Get Serious About Risk Management 5 Key Changes in ISO 14971:2019 Can Your Risk Management Prevent a Recall?

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Drug & Device Law

DECEMBER 29, 2023

2023) (First Amendment bars state-law misrepresentation claims over “truth” of published scientific article) ( here ); National Association of Wheat Growers v. Further, the plaintiffs’ arguments were based on scientific standards “not utilized by the FDA,” and thus preempted. C-8 Personal Injury Litigation , 87 F.4th 4th 315 (6th Cir.

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

Drug & Device Law

APRIL 21, 2023

Heck, Bexis and our colleague Matthew Jacobson even wrote a law review article on the topic a few years back. The FDA regulates medical devices, including 3d-printed medical devices when made by medical device manufacturers (see here for more information). But point-of-care devices appear to still be a matter of regulatory discussion.

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Drug & Device Law

MARCH 6, 2024

Last week we read a couple of online articles, including in the ABA Journal, about the unique questioning style of United States Senator John Kennedy (R- Louisiana) when it comes to federal judicial nominees. For example, Senator Kennedy has asked nominees: What does Article I of the Constitution cover? How about Article II?

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