FDA released a new small entity compliance guide May 18 intended to help small businesses comply with its new regulations on traceability and record-keeping for high-risk foods. The guide includes information on who must comply with the new regulations, when and what records must be kept, and how to request exemptions. Compliance with the final rule, which was published in November (see 2211150064), is required by Jan. 20, 2026.
On May 16, FDA posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On May 15, FDA posted new and revised versions of the following Import Alerts on the detention without physical examination of:
CBP reminded medical device importers of upcoming changes to FDA medical device authorization and import requirements following the recent expiration of the U.S. COVID-19 public health emergency on May 11, in a CSMS message issued the following day.
On May 11, FDA posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On May 10, FDA posted new and revised versions of the following Import Alerts on the detention without physical examination of:
FDA has issued its Enforcement Report for May 10, listing the status of recalls and field corrections for food, cosmetics, tobacco products, drugs, biologics and devices. The report covers both domestic and foreign firms.
On May 9, FDA posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On May 8, FDA posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On May 5, FDA posted new and revised versions of the following Import Alerts on the detention without physical examination of: