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The FDA De Novo medical device pathway, patents and …

    https://www.nature.com/articles/s41587-020-0653-6
    The interaction between patents and FDA’s De Novo FDA 501 (k) pathways present an opportunity for regulatory gamesmanship that potentially detracts from a history of robust development in the...

List of Off-Patent, Off-Exclusivity Drugs without an …

    https://www.fda.gov/drugs/abbreviated-new-drug-application-anda/list-patent-exclusivity-drugs-without-approved-generic
    List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic The FDA maintains a list of approved new drug application (NDA) drug products that are no …

Types of Medical Device Patents: What You Need to Know

    https://sterlingmedicaldevices.com/thought-leadership/medical-device-design-industry-blog/types-of-medical-device-patents-what-you-need-to-know/
    A provisional medical device patent gives you a year to begin the patent application process. After the year is up, your provisional patent will convert to a non …

Frequently Asked Questions on Patents and Exclusivity

    https://www.fda.gov/drugs/development-approval-process-drugs/frequently-asked-questions-patents-and-exclusivity

    Types of Medical Device Patents - The Rapacke Law Group

      https://arapackelaw.com/patents/medical-device/types-of-medical-device-patents/
      Medical devices generally qualify for utility patent protect, meaning that as a product, process or machine, a novel and non-obvious …

    Class I and Class II Device Exemptions | FDA

      https://www.fda.gov/medical-devices/classify-your-medical-device/class-i-and-class-ii-device-exemptions
      Devices which may not be subject to 510 (k) requirements include: Preamendments devices (please refer to FDA’s guidance “ Intent to Exempt Certain …

    How To Patent a Medical Device - Carevoyance

      https://www.carevoyance.com/blog/how-to-patent-a-medical-device
      Step 1: Decide if You Need a Patent Patents are typically given for tangible items, whereas servicemarks, copyrights, and trademarks are for artistic expressions, literary works, or other intellectual works that …

    Medical Device Patents: Everything You Need to Know

      https://www.upcounsel.com/medical-device-patents
      The judgments in patent cases related to medical devices can be significant, with some patent owners being awarded millions of dollars after their device was used …

    How Long Do Medical Device Patents Last? | PatentPC

      https://www.patentpc.com/blog/how-long-do-medical-device-patents-last
      A medical device patent generally lasts 20 years, but it can be longer if a product changes over time or undergoes significant development. This article will review …

    US10639502B2 - Medical device - Google Patents

      https://patents.google.com/patent/US10639502B2/en
      The medical device includes an interface configured to operatively connect to a removable storage device storing authorization data that identifies a level of treatment …



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