On Jan. 5 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Jan. 4 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
The Food and Drug Administration is seeking comments by April 4 on a proposed policy change that would subject certain medical procedure kits to unique device identifier data submission and labeling requirements, it said (here). Outlined in a draft guidance released on Jan. 4 (here), FDA’s new draft definition for medical device “convenience kits,” which are currently exempt from some UDI requirements, would exclude kits containing devices that are meant to be reused or replaced.
On Dec. 31 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
The Food and Drug Administration removed three perfluoroalkyl ethyl containing food-contact substances used as oil and water repellants for paper and paperboard, it said in a final rule that takes effect Jan. 4 (here). The rule removes the additives -- diethanolamine salts of mono- and bis, pentanoic acid, and perfluoroalkyl substituted phosphate ester acids -- from the agency's regulations for indirect food additives.
On Dec. 29 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
The Food and Drug Administration is withdrawing a draft guidance document it issued in 2010 on acidified foods, it said (here). FDA is withdrawing the draft guidance because many of its topics are now being addressed by other documents, it said.
The Food and Drug Administration considers its Automated Commercial Environment filing requirements to be “outlined,” according to a list of questions and answers posted by Integration Point following a Dec. 10 webinar (see 1512110027). Responding to a question on whether the agency’s required data elements are “locked down,” FDA said “any additional updates are refinements or clarifications, until such a time that new regulatory requirements indicate the need for further changes,” according to Integration Point, which hosted the webinar. The Q&A also includes information on the FDA ACE pilot, DUNS numbers, FDA’s “lockdown” policy of no changes to entry data within five days of arrival, and foreign-trade zones, among other topics.
On Dec. 28 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Dec. 24 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of: