FDA Law Blog

OCTOBER 2, 2024

By Adrienne R. Lenz, Principal Medical Device Regulation Expert & Lisa M. Baumhardt, Senior Medical Device Regulation Expert & Gail H. Javitt — A recent draft guidance on predetermined change control plans (PCCP) for medical devices continues FDA’s effort to implement Section 515C of the Food and Drug Omnibus Reform Act of 2022 (FDORA), which Congress enacted to make it easier for manufacturers to make post-market device changes by avoiding the need for additional FDA authorization (se

Medical 59

Medical Specialization Manufacturing IT 59

PEMBlog

OCTOBER 2, 2024

In this episode of PEM Currents: The Pediatric Emergency Medicine Podcast , I explore the complexities of gastroesophageal reflux (GER) and gastritis in children and adolescents. I’ll make the important distinction between gastritis – which is diagnosed only via endoscopy – and dyspepsia, the term best used to describe the symptoms many patients experience.

Diagnosis 52

Diagnosis Management IT Patient-Centered 52

Plum Health

OCTOBER 2, 2024

Ever found yourself in a medical bind, but not quite sure if it's an emergency? That's where urgent care centers come in handy. These facilities offer a wide range of medical services, from treating minor injuries to managing chronic conditions, without the long wait times and hefty price tag of an emergency room. Understanding Urgent Care Centers Think of urgent care as your neighborhood medical clinic on steroids.

Emergency Room 52

Emergency Room Healthcare Patient-Centered Chronic Disease Management 52