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An Overview on the Regulation of Medical Devices

An Overview on the Regulation of Medical Devices

The US Congress passed the Federal Food, Drug, and Cosmetic Act in 1938 (the FD&C Act), which empowered the US Food and Drug Administration (the FDA) to oversee the safety of, among other things, medical devices. Generally, the FDA is charged with approving...
What is Pre-Market Notification or 510(k)?

What is Pre-Market Notification or 510(k)?

The US Congress passed the Federal Food, Drug, and Cosmetic Act in 1938 (the FD&C Act), which empowered the US Food and Drug Administration (the FDA) to oversee the safety of, among other things, medical devices.  The FDA establishes strict requirements for...
What is Pre-Market Notification or 510(k)?

The Advent of Tele-Health

Particularly, due to COVID-19, an influx of medical professionals has begun to add tele-health services to their repertoire. These services allow patients, during a public health crisis, to have unfettered access to healthcare professionals who may not have otherwise...
Corporate Practice of Medicine Doctrine: An Overview

Corporate Practice of Medicine Doctrine: An Overview

Certain companies and investors, particularly in the healthcare technology and telehealth sphere, may run afoul of the Corporate Practice of Medicine Doctrine (CPOM). Corporations may have a vested interest in starting healthcare and healthcare technology companies,...
Pre-Market Approval of Medical Devices

Pre-Market Approval of Medical Devices

Pre-Market Approval, known as PMA, is the Food and Drug Administration’s review process to evaluate the safety and effectiveness of Class III medical devices. Class III devices are those that support or sustain human life, are of substantial importance in preventing...