FDA Law

JANUARY 18, 2022

In October 2014, FDA held a public workshop titled “Additive Manufacturing of Medical Devices: An Interactive Discussion on the Technical Considerations of 3D Printing.” The first scenario is a healthcare facility using a medical device 3D-printing production system. use in education, construction, art, and jewelry).

Medical 98

Medical Manufacturing Healthcare Government 98

FDA Law

JANUARY 18, 2022

In October 2014, FDA held a public workshop titled “Additive Manufacturing of Medical Devices: An Interactive Discussion on the Technical Considerations of 3D Printing.” The first scenario is a healthcare facility using a medical device 3D-printing production system. use in education, construction, art, and jewelry).

Medical 75

Medical Manufacturing Healthcare Government 75

FDA Law

NOVEMBER 29, 2023

See our prior blog post on the topic here. The evidence used to measure the device’s performance should be scientifically and clinically justified, consistent with the level of risk for the proposed change.

Management 115

Management Manufacturing Medical Healthcare 115

FDA Law

SEPTEMBER 29, 2023

For more than 30 years, FDA has asserted that it has jurisdiction to regulate LDTs as medical devices and clinical laboratories as manufacturers. As we have blogged about extensively over the years, FDA has initiated, but not completed, many efforts through different means to create a regulatory framework for LDTs.

Manufacturing 59

Manufacturing Clinic Screening Healthcare 59

FDA Law

AUGUST 4, 2022

Pfizer manufactures tafamidis, a breakthrough treatment for a rare, progressive heart condition known as transthyretin amyloid cardiomyopathy. Whether the Beneficiary Inducement Statute (BIS) is relevant to interpreting the AKS (essentially, no). Background. Pfizer set the price of tafamidis at $225,000 for each one-year course of treatment.

Manufacturing 98

Manufacturing Medical Government IT 98

FDA Law

AUGUST 30, 2021

We have previously posted blogs about FDA’s increasing interest on cybersecurity both in the premarket (see our past blog posts here , here , and here ) and the postmarket space (see our past blog posts here and here ). FDA is now expanding its cybersecurity effort in servicing of medical devices. privileged access issue)?

Medical 52

Medical Manufacturing Diagnose Healthcare 52

FDA Law

OCTOBER 6, 2023

There is much to unpack, and we intend to do so in a series of blog posts. The brevity of this change belies the foreseeably seismic impact of FDA regulation of clinical laboratories on the healthcare system. Future blog posts will analyze FDA’s legal authority as well as FDA’s claimed public health need for LDT regulation.

Provider 64

Provider Manufacturing IT Medical 64