FDA’S NEW DRAFT GUIDANCE FOR HUMAN FACTORS INFORMATION IN MARKETING SUBMISSIONS
In December of 2022, the FDA released draft guidance[1] to aid medical device manufacturers in determining what information should be included in marketing submissions for medical devices using a risk-based approach. The guidance outlines how to determine a submission category, each category requires different amounts of documentation. This framework aims to improve the efficiency of FDA […]
US FAVORED OVER EU FOR MEDICAL DEVICE MARKET ENTRY
The US market has emerged as the chosen geography for market entry for new medical technology. Historically, medical device companies preferred to launch in Europe as the product registrations were perceived as more straightforward. In a survey from December 2020, the most challenging geography was identified as China and the least challenging was Europe and […]
NOT DEVICES ANYMORE: THE FDA REDEFINES SOFTWARE IN EIGHT CLASSIFICATIONS
The FDA has officially excluded certain software from the definition of a medical device (Final Rule: 86 FR 20278). Eight regulations are being amended. The classifications include Clinical Chemistry and Clinical Toxicology Devices under Part 862, Immunology and Microbiology Devices under Part 866, General Hospital and Personal Use Devices under Part 880, Obstetrical and Gynecological […]
