On April 4 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On April 3 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 proposing to require premarket approval for three devices: sorbent hemoperfusion devices for treatment of hepatic coma and metabolic disturbances; cranial electrotherapy stimulators for treatment of depression, anxiety, and insomnia; and transilluminators for breast evaluation. Should FDA finalize its proposed order, a pre-market approval (PMA) application or notice of development of product development protocol (PDP) will be required before commercial distribution of these class III devices. Comments on the proposed order are due by May 6. The PMA requirements would be effective 90 days from issuance of the final order.
The Food and Drug Administration issued its weekly Enforcement Report for April 3 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 and the Parenteral Drug Association plan a public conference on "Driving Quality and Compliance Throughout the Product Life Cycle in a Global Regulatory Environment," according to a Federal Register notice. The conference will explore ways to ensure conformance with regulations that facilitate improvement of safe and effective medical products, it said. The all-day conference will begin at 7 a.m. Sept. 16 and continue through Sept. 18 at the Renaissance Washington Hotel in Washington, D.C. Further information: Wanda Neal, 301-656-5900, ext. 111 or info@pda.org.
The Food and Drug Administration sent a warning letter March 15 to South Korean device manufacturer Feel-Tech, alleging violations of current good manufacturing practices at the company’s Cheonan-si facility. Among the violations were insufficient corrective action plans to prevent recurrence of needles dislodging from its syringe barrels. The syringes had been the subject of two separate recalls due to the problem. FDA ordered the company to respond within 15 days of receipt of the letter, warning that premarket approval applications from the company may be denied until the violations are corrected.
The Food and Drug Administration issued the April Interstate Certified Shellfish Shippers List (ICSSL). The ICSSL is published monthly for the information and use by food control officers, the seafood industry and other interested persons. The shippers listed have been certified by regulatory authorities in the U.S., Canada, Chile, Korea, Mexico and New Zealand under the uniform sanitation requirements of the National Shellfish Program.
The Food and Drug Administration will continue to refuse imports of active pharmaceutical ingredients (API) manufactured by Japanese company Asada Milling Co., Ltd.’s facility in Kanra, Japan, it said in a warning letter. The products at the facility were already subject to import alert for current good manufacturing practice violations. The company failed to correct the problems, FDA said.
On April 2 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
During the week of March 25-31, the Food and Drug Administration modified the following existing Import Alerts (not otherwise listed on the FDA's new and revised import alerts page) on the detention without physical examination and/or surveillance of: