On Oct. 7, 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. 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.
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.
On Oct.6, FDA posted new and revised versions of the following Import Alerts on the detention without physical examination of:
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:
The FDA recently updated a guidance document outlining its enforcement policy for face masks, barrier face coverings, face shields, surgical masks and respirators during the COVID-19 pandemic, it said in a notice released Oct. 5. The latest version covers barrier face coverings intended for a medical purpose but not intended to provide liquid barrier protection, including FDA’s technical and labeling recommendations. It also removes reference to use of alternatives when FDA-cleared or NIOSH-approved N95 respirators are not available because the Centers for Disease Control and Prevention (CDC) and the FDA now recommend that healthcare facilities should not be using crisis capacity strategies at this time, and adds a policy that, during the public health emergency, the agency generally does not intend to object to stockpiled, non-NIOSH-approved disposable filtering facepiece respirators (FFRs) being further distributed and used as face masks for source control (as opposed to use as FFRs for respiratory protection) by the public and healthcare providers where such use does not create an undue risk in light of the public health emergency.
On Oct. 1, FDA posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Sept. 30, 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 Sept. 29, 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.