Medical Device and Pharma Innovation
The United States has the most technologically advanced medical devices and pharmaceutical products in the world. New medical devices that improve existing therapies or introduce a new therapy are continually being introduced, as are new new and innovative pharmaceutical products that fill a need for a new treatment or improve existing treatments.
And though innovation thrives in the U.S., there is a regulatory framework in place to ensure that medical devices and pharmaceuticals placed on the market are safe and effective. This means that manufacturers of moderate- to high-risk devices and drugs must demonstrate that their new or modified product is safe and effective before receiving FDA marketing approval or clearance.
New Drugs and Devices
New pharmaceutical products must prove their safety and efficacy through the FDA’s traditional approval process or its Accelerated Approval program. Read more.
New medical devices are approved for marketing based on FDA regulations to enforce the Medical Device Amendments (MDAs) of the Food, Drug and Cosmetic Act. Devices are classified and approved based on established marketing approval tracks, such as Pre-Market Notification, also known as 510(k) and Pre-Market Approval (PMA). Read more.
Innovation Headlines
A Team-based Approach to an Expedited 510(k)
Getting an expedited 510(k) submission So, you have created a new medical device by following your quality system’s design controls to plan the project, define design inputs, test to verify that outputs meet inputs, and validated your production product. Now what?...
FDA Approves Lamzede for Treatment of Alpha-mannosidosis
The U.S. Food and Drug Administration (FDA) on February 17, 2023 announced the approval the first-ever enzyme replacement therapy (ERT) for the treatment of rare alpha-mannosidosis, a genetic disorder that affects an individual's ability to break down complex sugars....
FDA Approves Rukabia for HIV Treatment
The U.S. Food and Drug Administration (FDA) on December 22, 2022 announced the approval of a new HIV drug called Rukobia (fostemsavir) for adults living with HIV who have limited treatment options. This drug is the first in a new class of HIV medications known as...
FDA Approval for Cancer Treatment Aid
The Food and Drug Administration (FDA) on 12 December 2022 announced the approval of Agilent's Resolution CTDX FIRST, a new in vitro diagnostic (IVD) medical device for use in the detecting a specific mutation in the KRAS gene in circulating cell-free DNA. This test...
FDA Accelerated Approval for Alzheimer’s Disease Treatment
The US Food and Drug Administration (FDA) announced on 06 January, 2023 that it had granted accelerated approval for the Alzheimer's disease treatment Leqembi. This is a significant milestone in the fight against Alzheimer's, a debilitating and progressive brain...
FDA Approves Sentimag Magnetic Localization System for Biopsies
Magtrace® and Sentimag® Magnetic Localization System Novel sentinel lymph node localization technique without radiation On December 6, 2022, the U.S. Food and Drug Administration (FDA) approved PMA P160053 Supplement S002 for the Magtrace and Sentimag Magnetic...
FDA Information – Conveniently Organized and Accessible
Quickly find the FDA information you need Conveniently organized FDA information. The U.S. Food and Drug Administration (FDA) provides a wealth of information for consumers and industry stakeholders. The problem is, it can be difficult to navigate to the information...