Fda Medical Devices Patents

Recently Issued U.S. Patents to FDA | FDA

https://www.fda.gov/science-research/licensing-and-collaboration-opportunities/recently-issued-us-patents-fda

United States patent 10,007,920 was issued on June 26, 2018 for Device and method for detection of counterfeit pharmaceuticals and/or drug packaging. FDA inventors : Nicola Ranieri, Mark ...

Medical Device Databases | FDA

https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/medical-device-databases

Apr 6, 2022

Medical Devices | FDA - U.S. Food and Drug Administration

https://www.fda.gov/Medical-Devices

CDRH 2022 Annual Report. Accomplishments for 2022, including the Pandemic Response, MDUFA V, Device Innovation, over-the-counter (OTC) hearing aid final rule, and device …

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 and 510 (k) regulatory pathways has the potential to threaten follow-on innovation for medical devices. The US …

Frequently Asked Questions on Patents and Exclusivity

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

The Interplay Between the FDA Regulatory Process for …

https://www.finnegan.com/en/insights/blogs/ip-health-blog/the-interplay-between-the-fda-regulatory-process-for-medical-devices-and-patent-law-considerations-for-510k-submission.html

For medical devices, patent law and FDA regulatory review processes can have considerable interplay. Previously, we provided a brief overview of the FDA …

Medical Device Safety | FDA - U.S. Food and Drug …

https://www.fda.gov/medical-devices/medical-device-safety

Medical Device Safety. The FDA monitors reports of adverse events and other problems with medical devices and alerts health professionals and the public when …

Medical Devices and the Intersection between FDA and …

https://www.mintz.com/insights-center/viewpoints/2018-10-02-medical-devices-and-intersection-between-fda-and-patent-law

Medical device regulation, particularly 510 (k) submissions, is a tradeoff between permitting the quick introduction of new devices and maintaining FDCA …

Medical Device Patents and FDA review of medical Device software

https://www.patentpc.com/blog/medical-device-patents-and-fda-review-of-medical-device-software

Medical device software, including software used in diagnostic or therapeutic applications, is also eligible for patent protection. However, unlike traditional medical …

Guidance on Medical Device Patient Labeling | FDA

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-medical-device-patient-labeling

Dockets Management Food and Drug Administration 5630 Fishers Lane, Rm 1061 Rockville, MD 20852 All written comments should be identified with this document's …