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Archive for the ‘Medical Devices’ category

On October 14, 2016, the U.S. Food and Drug Administration (FDA) announced a proposed rule that would require device manufacturers to submit labels and package inserts to FDA electronically when listing Class II and Class III home-use devices. The rule would allow manufacturers to submit labels and package inserts for Class I or other excluded […]

On September 6, 2016, the U.S. Food and Drug Administration (FDA) issued an extension to the Unique Device Identification (UDI) compliance deadline for certain class II devices. The original compliance date of September 26, 2016 for the UDI label and submission of data to the Global Unique Identification Database (GUDID) has been extended to September […]

The compliance date for device labelers to place Unique Device Identifiers (UDIs) on their Class II devices is approaching quickly.  Under the U.S. Food and Drug Administration (FDA) final rule, Class II devices must be labeled with UDIs starting September 24, 2016.  FDA consulting firm Registrar Corp is providing tips to help labelers of Class […]

The U.S. Food and Drug Administration (FDA) published its annual user fees for medical devices and generic drugs for fiscal year 2017 (October 1, 2016 through September 30, 2017). Medical Device User Fees for FY 2017 Establishment Registration Fee: $3,382 (No Reduction for Small Businesses) Premarket Application (PMA, BLA, PDP): $234,495 / $58,624 for Small […]

In early February, the U.S. Food and Drug Administration (FDA) sent e-mails to medical device establishments that had not yet renewed their FDA registrations for fiscal year (FY) 2016.  The e-mails state that “Failure to complete your annual registration by February 22nd, 2016, will result in your establishment being removed from FDA’s database of active […]

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Registrar Corp assists businesses with U.S. FDA compliance. Certificates of Registration issued by Registrar Corp provide confirmation to industry that you are fulfilling U.S. FDA registration requirements. U.S. FDA does not issue or recognize Certificates of Registration. Registrar Corp is not affiliated with the U.S. Food and Drug Administration.

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