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Regulatory Updates FDA PMA eSTAR Draft Guidance: What Sponsors Need to Know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)...
US FDA Compliance 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...
US FDA Compliance Veterinary Pharmaceuticals Regulations and Registration in USA
For veterinary pharmaceuticals to be sold in the U.S. market, they must be approved by the FDA Center for Veterinary...
US FDA Compliance 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...
US FDA Compliance 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...
US FDA Compliance 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...
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EU Medical Device Recognition
India now allows eligible medical devices approved in the European Union to be considered...
Qurious RI DMF Database
Qurious RI’s DMF Database module offers a platform for tracking evidence-based, audit ready DMFs...
UK AI Medical Device
In the UK, AI medical devices fall under the Medical Devices Regulations 2002 (UK...