Between October 1 and December 31 every year, FDA-registered facilities around the world must submit renewals to their registrations (except registered food facilities, which must renew every even-numbered year). If your facility is registered with FDA, then this...
Multiple-Use Devices Devices intended for multiple use, and intended to be reprocessed before each use, will likely have their original packaging discarded when the device is first used. Therefore, these devices must bear a Unique Device Identifier (UDI) as a...
Update 8/27/2018 Unique Device Identifier Deadlines – 2018 Medical device labeling requirements differ from other regulated products because they are required to include a special barcode, a Unique Device Identifier, that is unique to each medical device. Obtaining an...
Chinese companies exporting foods, drugs or medical devices to the USA: be aware! FDAImports.com has recently learned China’s FDA inspections include verifying the U.S. FDA registrations of Chinese manufacturers. China FDA is not just verifying companies have valid...
Benjamin England, FDAImports.com Founder and CEO recently presented a webinar with FDANews, entitled “Thinking Ahead of FDA: Preventive care tips for your FDA import compliance program.” Mr. England said, “Up to now, FDA has been mostly reactionary in its enforcement...
UPDATE 03/02/2017 FDA’s Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates are out for FY 2017. The domestic reinspection rate was not changed from the 2016 rate. Surprisingly, the foreign reinspection rate, which has been...
FDA’s Center for Devices and Radiological Health published its Medical Device Recall Report for the last decade. The number of recalls almost doubled, approximating the increase in device spending over the same period of time. However, the report attributes the bulk...
Device manufacturers take note: Changes in regulations accompanying the Unique Device Identifier (UDI) regulation took effect on December 23, 2013. The new UDI regulations reach far and wide. In addition to creating a new regulation at 21 CFR 830, changes also...
Shuttered up and closed - the government shutdown was painful for many U.S. businesses. This was especially true for any business having to deal with FDA. FDA lost over 50% of its employees during the shutdown. Many of those furloughed were investigators and internal...
FDA makes mistakes just like everyone else, so don’t assume that FDA is always right. We experienced a case where FDA placed the wrong firm on Import Alert 86-07 (“Detention without Physical Examination of and Guidance of Impact-Resistant Lenses in Eyeglasses and...
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