Changing Name Medical Device

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FAQs about the New Device Registration and Listing …

https://www.fda.gov/medical-devices/device-registration-and-listing/frequently-asked-questions-about-new-device-registration-and-listing-requirements

1. What changes to device registration and listing requirements became effective on October 1, 2012? The changes are: 1. All proprietary names under which a device is marketed must be reported, at a minimum, when a device is first listed and during the annual update of registration and listing … See more

Navigating name changes and re-registration - Medical Device

https://www.rcainc.com/wp-content/uploads/2017/11/Navigating-Name-Changes-and-Re-registration.pdf

a manufacturer change or product name change requires modifications to the product labeling and regulatory re-registrations, which are increasingly complex. This article …

Changing a Medical Device Product Name - elsmar.com

https://elsmar.com/elsmarqualityforum/threads/changing-a-medical-device-product-name.43342/

Changes to the labeling of PMA devices may require submission of a new 510 (k) (probably a Special), or may only require a memo to file. The "A" section of the …

Product Re-Registration | Pharmaceutical Consultant

https://www.rcainc.com/white-papers/navigating-complexities-changing-product-names-re-registrations/

Navigating the Complexities of Name Changes and Re-registration. Too often medical device manufacturers overlook the complexities of changing product names or ownership …

Navigating Name Changes and Reregistration

https://www.mddionline.com/packaging/navigating-name-changes-and-reregistration

Navigating Name Changes and Reregistration. Too often medical device manufacturers overlook what changing product names or ownership truly involves. Chris …

Name That Medical Device; a Guide to …

https://www.mddionline.com/product-development/name-medical-device-guide-medical-device-branding

Don't forget about form factor in your medical device branding Form factor names draw their inspirations from the device’s shape, number of component parts, or size. Examples of shape …

Reclassification | FDA - U.S. Food and Drug Administration

https://www.fda.gov/medical-devices/classify-your-medical-device/reclassification

The regulatory class of a device type, as defined in Section 513 (a) of the Federal Food, Drug and Cosmetic Act (FD&C Act) (21 U.S.C. 360c (a)) and its implementing regulation …

Change Registration Information for a …

https://www.access.fda.gov/drlm/help/ChangeRegistrationInformationForAFacility.html

Review all information associated with a device Edit information for a Listing: Remove a product from facility’s listing Edit selected listing Add new products These options are used to update...

Change name in the Professional Medical Release

https://www.dochub.com/en/functionalities/change-name-in-the-professional-medical-release

Easy steps to change name in Professional Medical Release Go to the DocHub site and click the Create free account key to start your signup. Give your email …

MDR - Guidance on Significant Changes for Medical Devices

https://decomplix.com/medical-device-significant-changes/

If the change affects the device’s intended purpose, design/performance specification, software (whether embedded or standalone), materials (of any nature), or …

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