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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
Medical Device Databases | FDA
- https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/medical-device-databases
- Apr 6, 2022
Nomenclature of medical devices - World Health …
- https://www.who.int/teams/health-product-policy-and-standards/assistive-and-medical-technology/medical-devices/nomenclature
- The nomenclature of medical devices is a coding and naming system used to generically classify and identify all medical devices and related health products. According to …
Proprietary Name Review for Biologic Products | FDA
- https://www.fda.gov/vaccines-blood-biologics/labeling-cber-regulated-products/proprietary-name-review-biologic-products
- The "proprietary name" or "trade name" of a product is the name that will: be used by the applicant or other entity for the commercial distribution of the product; identify the specific …
Private Labeled Devices with FDA Approval
- https://medicaldeviceacademy.com/private-labeled-devices-with-fda-approval/
- Answer to the fourth question about private labeled devices. If the distribution company is the initial importer of a device into the USA, then the distributor …
Best Practices in Developing Proprietary Names for …
- https://www.fda.gov/regulatory-information/search-fda-guidance-documents/best-practices-developing-proprietary-names-human-prescription-drug-products-guidance-industry
- FDA is issuing this guidance to help sponsors of human prescription drug products develop proprietary names for those products. This guidance describes best …
Best Practices in Developing Proprietary Names for …
- https://www.fda.gov/regulatory-information/search-fda-guidance-documents/best-practices-developing-proprietary-names-human-nonprescription-drug-products-draft-guidance
- FDA is issuing this guidance to help sponsors of human nonprescription drug products develop proprietary names2 16 for those products. This guidance describes …
FDA Issues Draft Guidance on Proprietary Names
- https://www.policymed.com/2021/02/fda-issues-draft-guidance-on-proprietary-names.html
- The U.S. Food and Drug Administration (FDA) issued a pair of draft guidance documents aimed at guiding the selection of proprietary names for prescription and non …
PROPRIETARY MEDICINES. SOME GENERAL …
- https://jamanetwork.com/journals/jama/fullarticle/457837
- Proprietary preparations controlled by copyright or trade names are generally mixtures, and are often secret or semi-secret in character. It is the name of the article that protects it. …
Proprietary drug - Wikipedia
- https://en.wikipedia.org/wiki/Proprietary_drug
- Figure 1: Five best-selling proprietary drug which lost their patents before 2017. Proprietary drug is a substantial business protected by its respective patent.They are …
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