510(k) Clearance
510(K) CLEARANCE CASE STUDY CHALLENGE:The manufacturer of a new laser-resistant endotracheal tube device needed to use an older predicate for their 510(k) submission to the FDA. While still commercially available, the predicate device was over 20 years old at the time of submission, with limited regulatory information and test data available. FDA often imposes closer […]
GMP and CE Certification
GMP AND CE CERTIFICATION CASE STUDY CHALLENGE:A major pharma company purchased a medical device business, seeking to achieve FDA clearance, CE certification and remain compliant under GMP regulations. APPROACH:An experienced AlvaMed team developed a project plan consistent with ISO 13485 and the European Union regulations. AlvaMed’s team: RESULTS:Risk analyses and a 510(k) draft were completed […]
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) […]
