SQA

SEPTEMBER 2, 2022

The new guidance from the European Medical Device Coordination Group (MDCG) covers “borderline products” not easily categorized either as medical devices falling under MDR requirements or medical products for human use falling under Directive 2001/83/EC (MPD) requirements for CE Marking.

FDA 91

FDA COVID-19 Nursing Homes Compliance 91

SQA

MAY 17, 2022

Requirements for classification and related issues established under RDC 185/2001, as well as other relevant medical device regulations, will apply for SaMD, as well. The Points is an upgraded version of Practice for Cosmetics Production Licensing , implemented in 2016, with more stringent inspection requirements.

FDA 75

FDA Compliance Informed Consent Hospitals 75

SQA

DECEMBER 16, 2022

ANVISA announced major updates to its Resolution of the Collegiate Board of Directors (RDC) 185/2001. United States Food and Drug Administration (FDA) – Regulations and guidance. The FDA is issuing this guidance to provide clarity and predictability for software manufacturers on this topic.

FDA 40

FDA Compliance COVID-19 Licensing 40

Hall Render

JUNE 14, 2024

NATIONAL AHA Comments on CMS’ Inpatient Payment Proposal for FY 2025 AHA urges CMS to make Transforming Episode Accountability Model voluntary AMA adopts new policy to create equity in clinical trials and research DOJ loses bid to toss Humana Medicare Advantage case Drug shortages hit highest number since 2001, impacting patients, hospitals and pharmacies (..)

US Department of Health and Human Services 40

US Department of Health and Human Services Nursing Homes Nurses Hospitals 40

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.”. 341 (2001), the U.S.

FDA 59

FDA Licensing Compliance 59

Drug & Device Law

JANUARY 4, 2024

That Complaint alleges various antivax conspiracy theories concerning COVID-19 vaccines, the FDA, emergency use authorizations, and the media that have circulated since these vaccines first became available. The FDA, however, did not and does not share that belief. FDA (8/23/21) press release (emphasis original).

COVID-19 Vaccine 59

COVID-19 Vaccine COVID-19 FDA Public Health 59

Drug & Device Law

SEPTEMBER 29, 2022

Before a biologic may be marketed, the manufacturer must obtain a license from the FDA. Approval of an application “constitute[s] a determination” by the FDA “that … the product meet[s] applicable requirements to ensure the continued safety … of such products.” See 42 U.S.C. § See 21 C.F.R. 2022 WL 4305656, at *8.

FDA 59

FDA Licensing Fraud 59