The Food and Drug Administration sent a warning letter to Belgian device manufacturer Medsys, alleging several violations of FDA regulations including Medical Device Reporting. FDA said it will deny premarket approval applications for Class III devices related to the violations, and will not grant requests for certificates to foreign governments, until the violations have been corrected.
The Food and Drug Administration said a draft guidance on distinguishing device recalls from product enhancements is now available. The guidance would clarify when a change to a device meets the definition of a recall, and whether FDA should be notified. Device improvements do not necessarily mean old versions of a device need to be recalled, FDA said, but when the new version of a device corrects an identified defect or failure the public should be notified without delay. Comments on the draft guidance are due by May 23.
On Feb. 19 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
In arguing that the Food and Drug Administration’s implementation of the Food Safety Modernization Act has been too slow, “plaintiffs fail to appreciate the complexity of the tasks at hand and the real, concrete, and substantial progress the agency has made to date,” said the FDA in its reply to the Center for Food Safety’s Jan. 11 motion to compel issuance of several long-overdue FSMA regulations. The non-profit wants the Northern California District Court to mandate a timetable for FDA to issue FSMA regulations, including third-party auditing and the Foreign Supplier Verification Program.
The Food and Drug Administration is asking for comments by May 21 on a request to change the standard of identity for milk and 17 other dairy products to allow use of artificial sweeteners in flavorings used in milk. The petition, filed by the International Dairy Foods Association and the National Milk Producers Federation, seeks to amend several standards of identity in 21 CFR 131 to allow use of “any safe and suitable sweetener” in optional characterizing flavoring ingredients used in milk. The provisions currently allow use of a “nutritive sweetener.” The amendments would allow use of aspartame in flavored milk and milk products, promoting more healthful eating practices and reducing childhood obesity, the petitioners said.
On Feb. 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 Feb. 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 is extending until May 16 the period for submission of comments related to information collection provisions of its proposed rules on produce safety and preventative controls. The two proposed food safety rules, “Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventative Controls for Human Food,” and “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption,” published Jan. 16, apply to both foreign and domestic producers. The 90-day extension of the period for comments on proposed information collection requirements means the deadline for all comments, whether related to provisions of the proposed rules or the information collections, falls on the same date.
Domega NY International is recalling Green Day brand dried coconut it imported from China because it contains undeclared sulfites. The recalled product comes in a 3 oz., clear plastic bag with the following code: Exp 09/13/2014. The UPC code is 6 950296 800744. The dried coconut was sold in New York, N.Y. No illnesses have been reported to date in connection with the problem.
ZIP International Group of New York is recalling dry salted fish because the product was found to be uneviscerated and may be contaminated with Clostridium botulinum. The recalled product, dry salted fish (bream) imported from Russia, was distributed by East Coast Foods, also of New York, to retail stores and wholesalers in September 2012. It is packaged in sealed packaging labeled "Astrakhansky Lesh" (Dry Salted Fish Eviscerated) weight 14.2oz. Bar Code 835856001228 is located on the top right corner of the package.