Regulatory Open Forum

Dear Mr. David Lim

I do agree that the statement "There is no explicit requirement for Postmarket surveillance in the USA legislation..." in my attached document (RIVM Letter report 2015-0001) is not accurately stated.

In fact Section 522 of the US Federal Food, Drug and Cosmetic Act (the Act), the new Postmarket Surveillance guidance (Issued on May 16, 2016) under Section 522 of the Federal Food, Drug, and Cosmetic Act and CFR 21 Part 822 Subpart C in my opinion give a comprehensive description of the Postmarket surveillance process in USA.

The References section (ref. #44. and #47.) of the attached document do include ref. to the above mentioned FDA docs, however it can still be asked the meaning of the statement "...no explicit requirement for Postmarket surveillance in the USA legislation...".

Thank you for giving us the opportunity to learn from your comment.

Sincerly,

Barbara Drago

The document states "There is no explicit requirement for post market surveillance in the USA legislation." See Conclusions Under Section 11.  This is not accurately stated.