Medical Device Regulation and Compliance Process in the USA: A Complete FDA Guide
FDA grants or approves a device through a premarket submission and it separately registers the manufacturing establishment and lists the […]
US FDA Compliance
Gain practical knowledge on navigating FDA regulations, including registration processes, documentation, and quality compliance. Resources designed to support companies in maintaining adherence to US federal guidelines.
QSR to QMSR: FDA Quality Management System Regulation for Medical Devices
For years, medical device manufacturers supplying the US market worked under FDA’s Quality System Regulation (QSR). That changed on February
FDA Q-Submission Program for Medical Devices: Types, Process & Timelines
Before committing to a medical device submission, many companies want to know where FDA stands. Is the testing plan adequate?
FDA PMA eSTAR Draft Guidance: What Sponsors Need to Know
On September 18, 2026, FDA’s Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER)
PADER in Pharmacovigilance: Meaning, FDA Requirements & Submission Timelines
PADER is short for Periodic Adverse Drug Experience Report. It is one of the ways FDA receives periodic postmarketing safety
FDA CDRH Annual Reporting Requirements for Laser Products
Manufacturers often assume that making a laser product means an annual FDA filing. That assumption is wrong. The obligation depends
Investigational New Drug (IND) Application Process, Types and Requirements
Federal law requires drugs to have an approved marketing application before transportation or distribution across state lines. However, a drug
Modernization of Cosmetics Regulation Act of 2022 (MoCRA): US FDA Requirements
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) was enacted on December 29, 2022. It came as part of
Cosmetics Regulations & Compliance Process in the USA
In the United States, cosmetic products and ingredients don’t need any pre-market approval. However, authorities may crack down on products