Labeling For Medical Products Not Made With Natural Rubber Latex
Some manufacturers label or promote their products as “latex free” or “does not contain latex” to inform users that natural rubber latex in any of its forms was not used in their product. In a guidance document titled "Recommendations for Labeling Medical Products to...
Seafood and Juice Industry: Pay Attention, the HARPC Final Regulation Affects You Too!
The seafood and juice industry largely sat on the sidelines while FDA worked with the rest of the food industry to develop the recently finalized Hazard Analysis, Risk-based Preventive Controls (alternatively known as HARPC, Preventive Controls Rule, or PC Rule). This...
Renewal Season Starts October 1 – Are You Ready?
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...
Preparing for FDA’s Final Ruling on the Foreign Supplier Verification Program (FSVP)
FDA plans to publish the final rule for the Foreign Supplier Verification Program (FSVP) on October 31, 2015 under the Food Safety Modernization Act (FSMA). This rule will require U.S. food importers to adopt an FSVP, verifying that the foods they import are safe and...
FDA publishes Hazard Analysis and Risk-Based Preventive Controls (HARPC)
Yesterday, September 10, 2015, FDA released the final rules for Preventive Controls on human and animal foods. This regulation has been a long time in coming, and will drastically change the landscape of food regulations for both domestic and foreign food facilities....
Still Waiting: FDA Not Yet Published the HARPC Final Rule
This week the Food and Drug Administration (FDA) was required to submit the final rule for the Hazard Analysis and Risk-Based Preventive Controls (HARPC) for publication in the Federal Register. According to FDA, this was completed on August 31, but curiously FDA has...
5 Things You Should Know About Import Alerts
Don’t Wait to Act Until FDA Adds the Company to Import Alert Waiting until you get red-listed before identifying what happened and fixing it is a big time-and-money mistake. However, if you wait until your company is added to an import alert, you will likely have a...
Special Cases for UDI Requirements
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...
Unique Device Identifier Deadline: September 24, 2015 – Are You Ready?
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...
FDA Import Screening Down, Down, Down
FDA’s electronic import entry review systems will be down for major upgrades from this Saturday, May 9, 2015 at 1:00 am EDT until Sunday, May 10 at 1:00 am EDT. This will impact primarily food imports and perishable imports. In addition to Prior Notices submitted...