Day: September 5, 2024

De Novo classification requests require a significant investment of time and resources. Many applicants are new to the FDA regulatory processes and need help in putting together a reasonable request. In the last few years, the FDA has tried to help medical device submitters with application formatting via its eSTAR templates. This month they expanded … Read more

Participating in clinical trials is expensive and may be financially untenable, especially for economically challenged participants. Sponsors often offer compensation to trial participants to alleviate this financial burden leading to an unintended negative consequence; the participants owe taxes on the payments received and might lose their eligibility for government financial assistance programs. A bill in … Read more