FDA Law

JUNE 28, 2021

Richardson — A recent proposed amendment to Minnesota’s Opiate Product Registration Fee appears intended to ensure continued availability of certain opiate products at hospitals. Whether HF33 is enacted or not, state legislative initiatives aimed at combatting the opioid epidemic continue to be a moving target for opioid manufacturers.

Hospital 52

Hospital Manufacturing Specialization Medical 52

FDA Law

OCTOBER 2, 2024

A draft guidance issued last year focused on PCCPs for devices incorporating artificial intelligence and machine learning (AI/ML), which we blogged about here ; this guidance has not yet been finalized. FDA, Guidance for Industry, The Special 510(k) Program (2019). Draft Guidance at 34.

Medical 59

Medical Specialization Manufacturing IT 59

FDA Law

MAY 3, 2021

We thought this would be a good time to post a series of blog posts focusing on DEA inspections and how registrants should prepare for and manage them, with a list of registrant do’s and don’ts. We will discuss these actions in more detail in later blog. 44,710, 44,716 (July 24, 2020). 21 U.S.C. §

Management 52

Management Manufacturing Specialization IT 52

FDA Law

MAY 3, 2021

We thought this would be a good time to post a series of blog posts focusing on DEA inspections and how registrants should prepare for and manage them, with a list of registrant do’s and don’ts. We will discuss these actions in more detail in later blog. 44,710, 44,716 (July 24, 2020). 21 U.S.C. §

Management 40

Management Manufacturing Specialization IT 40

FDA Law

FEBRUARY 22, 2023

In 2016 , the agency issued its definitive HF guidance, guide manufacturers through human factors engineering processes during the development of new medical devices, focusing specifically on the user interface. Consider this scenario: A manufacturer files a 510(k) for a Class II device, a surgical mask.

Manufacturing 64

Manufacturing Engineering Medical IT 64

FDA Law

APRIL 8, 2024

For generic drug manufacturing facilities specifically, the numbers are 63% and 87%. MRAP would provide oversight of an accreditation body which would conduct assessments—paid for by the manufacturer—based on criteria developed by the MRAP. HHS would then use MRAP scores in the proposed Hospital Resilient Supply Program (HRSP).

Supply Chain 59

Supply Chain Manufacturing Government Hospital 59