Submissions For Medical Devices That Include Antimicrobial Agents

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Premarket Notification 510(k) | FDA

https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/premarket-notification-510k

Each person who wants to market in the U.S., a Class I, II, and III device intended for human use, for which a Premarket Approval application (PMA) is not required, must submit a 510(k) to FDA unless the device is exempt from 510(k) requirements of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and does not exce… See more

Federal Register :: Draft Guidance for Industry and Food …

https://www.federalregister.gov/documents/2007/07/19/E7-13952/draft-guidance-for-industry-and-food-and-drug-administration-staff-premarket-notification

To receive “Premarket Notification (510(k)) Submissions for Medical Devices That Include Antimicrobial Agents,” you may either send an e-mail request to …

FDA Finalizing Guidance For Devices Containing …

https://medtech.pharmaintelligence.informa.com/MT026510/FDA-Finalizing-Guidance-For-Devices-Containing-Antimicrobial-Agents

FDA Spotlights Devices With Antimicrobial Surface Coatings. The agency is working to address regulatory conundrums with antimicrobial-coated devices designed to …

Antimicrobial Medical Devices in Preclinical …

https://link.springer.com/chapter/10.1007/978-1-4614-1031-7_13

Many types of catheters, stents, orthopedic devices, contact lenses, surgical meshes, shunts, sutures, cardiovascular replacements, and many other device …

Adding Antimicrobials to Medical Devices Requires New 510 (k)s, …

https://www.fdanews.com/articles/98139-adding-antimicrobials-to-medical-devices-requires-new-510-k-s-u-s-fda-says

Adding an antimicrobial agent to a marketed medical device generally represents a “significant modification” that requires a new 510 (k) submission, the U.S. …

FDA Regulatory Challenges for Antimicrobial Orthopedic Devices

https://www.odtmag.com/issues/2021-11-01/view_columns/fda-regulatory-challenges-for-antimicrobial-orthopedic-devices/

These strategies mainly are classified into bactericidal or superhydrophobic/anti-fouling. 5,6 Bacteriocidal orthopedic devices kill bacteria either …

Withdrawn Guidance | FDA - U.S. Food and Drug …

https://www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/withdrawn-guidance

Oct 17, 2022

FDA Issues List of Medical Device Guidance Documents …

https://www.natlawreview.com/article/fda-issues-list-medical-device-guidance-documents-planned-2013

Premarket Notification [510 (k)] Submissions for Medical Devices that Include Antimicrobial Agents Draft Guidance Topics Distinguishing and Reporting …

FDAnews — Information you need!

https://www.fdanews.com/ext/resources/files/03-15/03-11-15-HELPletter.pdf?1426102760

Notification (510(k)) Submissions for Nucleic Acid-Based Human Leukocyte Antigen (HLA) Test Kits Used for Transfusion and Transplantation Submitting Debarment Certification …

FDA Releases Priorities For 2105 Guidance Document ... - Med …

https://www.meddeviceonline.com/doc/fda-releases-priorities-for-guidance-document-publication-0001

510 (k) Submissions for Medical Devices that Include Antimicrobial Agents Balancing Premarket and Postmarket Data Collection for Devices Subject to …

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