On Sept. 14 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 issued its weekly Enforcement Report for Sept. 13 that lists the status of recalls and field corrections for food, drugs, biologics and devices. The report covers both domestic and foreign firms.
The Food and Drug Administration issued a new draft guidance document on regulatory considerations for microneedling products, it said. The document includes criteria for determining whether microneedling products, which are instruments with an array of needles or pins stamped or rolled across the skin to facilitate skin exfoliation or treat skin conditions, are considered by FDA to be medical devices. Microneedling devices that do not penetrate living skin and claim only to facilitate exfoliation, improve the appearance of skin, give skin a smoother look and feel or give skin a luminous look would not be considered medical devices by FDA, the draft guidance said. Comments are due Nov. 14.
On Sept. 13 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Sept. 11 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Sept. 8 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Sept. 7 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 issued its weekly Enforcement Report for Sept. 6 that lists the status of recalls and field corrections for food, drugs, biologics and devices. The report covers both domestic and foreign firms.
On Sept. 6 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and Drug Administration seeks input on existing regulations and related paperwork requirements that could be modified, repealed or replaced to reduce burdens on industry, it said. The effort is part of implementation of recent executive orders issued by Donald Trump on reducing and reforming regulations, FDA said. The agency seeks comments on regulations and paperwork requirements related to biologics, medical devices, drugs, foods, tobacco products and veterinary medicines, as well as regulations and paperwork requirements that may cut across several of its product-based centers.