FDA Law Blog

AUGUST 18, 2024

Gibbs — In 1997, Congress wisely amended the Federal Food, Drug, and Cosmetic Act (FDCA) by adding Section 513(f)(2) to establish the De Novo process. By Véronique Li, Senior Medical Device Regulation Expert & Jeffrey N.

In-Vitro 69

In-Vitro Radiology Cosmetics Medicine 69

FDA Law Blog

OCTOBER 14, 2021

Mullen — In recent years, for novel robot assisted surgery (RAS) devices, FDA’s Center for Devices and Radiological Health (CDRH) has taken the approach of clearing RAS devices for specific indications for use. Thus, this part of the Act becomes that much more important to healthcare providers innovating in the field of medicine.

Regulation 52

Regulation Medicine Radiology Cosmetics 52

The Pharma Data

NOVEMBER 12, 2021

director of the FDA’s Center for Devices and Radiological Health. “We An FDA investigator’s list of examination compliances doesn’t constitute a final FDA determination of whether any condition is in violation of the Federal Food, Drug, and Cosmetic Act or any of its enforcing regulations.

Compliance 40

Compliance Cosmetics Production Manufacturing 40

The Pharma Data

NOVEMBER 6, 2020

director of the Office of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health. PTSD is a disorder that develops in some people who have experienced a shocking, scary, or dangerous event. . .

Marketing 40

Marketing Production Radiology Regulation 40