Shutdown Realities At FDA: No New Submission Reviews, And More

Shutdown Realities At FDA: No New Submission Reviews, And More-thegraysheet:  Out-of-office email responses may be the most some in industry can expect from FDA during the ongoing partial government shutdown. In particular, new PMA and 510(k) submissions, and anything else tied to a user fee payment, are not being reviewed by FDA as of Oct. 1 as a result of the impasse in Congress on funding government agencies for the start of fiscal year 2014.