FDA Law

MARCH 6, 2024

FDA Law Blog readers can use discount code S10-866-866L24.S His practice supports clients throughout the life sciences from biotech startups and multinational pharmaceutical companies to CROs and academic researchers to patient advocacy organizations. We can offer our readers a special discount for the event.

Management 59

Management Manufacturing Specialization Government 59

FDA Law

APRIL 25, 2023

Shapiro — Does your firm manufacture a “cyber device”? Congress has given FDA the authority to require device manufacturers to provide cybersecurity information in their premarket submissions for a “cyber device.” We have recently blogged on this topic (“ Is my software a medical device? ”). Special 510(k)s.

Specialization 105

Specialization Provider Medical Manufacturing 105

FDA Law

MAY 19, 2023

In this blog we examine the Special Controls put in place to mitigate false results, incorrect interpretation of results, and incorrect operation of the device. In this blog we examine the Special Controls put in place to mitigate false results, incorrect interpretation of results, and incorrect operation of the device.

Specialization 40

Specialization Clinic Provider IT 40

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A draft guidance issued last year focused on PCCPs for devices incorporating artificial intelligence and machine learning (AI/ML), which we blogged about here ; this guidance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 Draft Guidance at 34.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).

Management 52

Management Manufacturing Specialization IT 52

FDA Law

OCTOBER 6, 2023

There is much to unpack, and we intend to do so in a series of blog posts. What, if any, unintended consequences may result from the proposed phaseout policy to certain patient populations (for example, Medicare beneficiaries, rural populations, etc.) Change to the IVD definition First, the mechanics of the change. 150,000).”

Provider 64

Provider Manufacturing IT Medical 64

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).

Management 40

Management Manufacturing Specialization IT 40