Change Trade 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 information. 2. Combinatio… See more

Changing a Medical Device Product Name - elsmar.com

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

10903 New Hampshire Avenue. Silver Spring, MD 20993-0002. If the new brand name implies the claims or a use that was not cleared in the original 510 (k) then …

Navigating name changes and re-registration - Medical Device

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

In the event of a company name change in the USA, the FDA requires an update to the registration per 21 CFR 807.26 and 21 CFR 807.30. In the event of a name change for …

PMA Frequently Asked Questions | FDA

https://www.fda.gov/medical-devices/premarket-approval-pma/pma-frequently-asked-questions

Yes, a PMA may be sold to another company. The sponsor must submit a PMA amendment to notify FDA of the new owner. The new sponsor is responsible for …

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 …

Change Registration Information for a …

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

Facility name and location. DUNS Number; Phone and fax numbers; Facility URL; Trade name(s) Owner/Operator information; Official Correspondent information; United States Agent information (for …

Medical Device Name Change | Regulatory Open Forum

https://connect.raps.org/discussion/medical-device-name-change

Medical Device Name Change. 0 Recommend. Mindy Rushing. Posted 24-May-2022 11:23. I'm preparing a PMA submission and my company wants to change the …

Name That Medical Device; a Guide to …

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

As noted at the beginning of the article, there are thousands of trademarked names in medical devices. Yet still, a real word that represents the qualities of the device can become an …

Register a New Medical Device Facility: …

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

The extension to be dialed (if any) is optional, but recommended. Foreign addresses: the country code, the three-digit city code, and the phone number are mandatory. FAX Number - country code. - 3 …

MDR - Guidance on Significant Changes for Medical Devices

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

One of the conditions for benefiting from the transitional provisions is that the legacy device does not undergo “significant changes in design or intended use ”. On 16 …

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