FDA ESTAR OVERVIEW
Currently, all medical device submissions for 510(k), De Novo, and Pre-Submissions may voluntarily use eSTAR. The intention of the program is to enhance the quality of submissions by providing a standardized format so submitters can ensure submissions are complete. Additionally, the review process can be streamlined and more efficient. Starting October 1, 2023, all 510(k) […]
GUIDANCE ON SIGNIFICANT CHANGES REGARDING THE TRANSITIONAL PROVISION UNDER ARTICLE 120 OF THE MDR
The European Commission published an updated Medical Device Coordination Group (MDCG) 2020-3 Rev.1 – Guidance on significant changes regarding the transitional provision under Article 120 of the MDR in May 2023. Changes were made throughout the guidance document to align it with Regulation (EU) 2023/607 (updates to MDR/IVDR transitional provisions) and with the similar guidance document for […]
FDA’S NEW DRAFT GUIDANCE FOR HUMAN FACTORS INFORMATION IN MARKETING SUBMISSIONS
In December of 2022, the FDA released draft guidance[1] to aid medical device manufacturers in determining what information should be included in marketing submissions for medical devices using a risk-based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 […]
