On Oct. 13, 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 Oct. 13, 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 Oct. 12, FDA posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Oct. 8, FDA posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Oct. 7, FDA posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Oct.6, FDA posted new and revised versions of the following Import Alerts on the detention without physical examination of:
FDA is imposing stricter regulatory controls on surgical staplers for internal use, reclassifying the medical devices from class I (general controls) to the higher-risk category class II (special controls), it said in a final order released Oct. 7. The change means surgical staplers for internal use will be subject to 510(k) premarket review requirements and other conditions prior to marketing the devices. The new classification does not affect surgical staplers for external use, which are being given a new, separate classification to distinguish them from those for internal use.
FDA has issued its Enforcement Report for Oct. 6, 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 Oct. 5, FDA posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Oct. 4, FDA posted new and revised versions of the following Import Alerts on the detention without physical examination of: