Medical Device Regulatory Submissions

Overview of Device Regulation | FDA

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

The basic regulatory requirements that manufacturers of medical devices distributed in the U.S. must comply with are: Establishment registration, Medical Device …

Premarket Approval (PMA) | FDA

https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/premarket-approval-pma

510(k) Submission Process | FDA

https://www.fda.gov/medical-devices/premarket-notification-510k/510k-submission-process

Send Medical Device eSTAR and eCopy Premarket Submissions Online October 3, 2022 - The FDA is announcing that you may now send electronic copy …

Leveraging Real World Evidence in Regulatory …

https://www.fda.gov/news-events/fda-voices/leveraging-real-world-evidence-regulatory-submissions-medical-devices

Advances in the availability of real-world data (RWD) sources – such as electronic health records, registries, medical claims, pharmacy data and feedback from wearables and …

The Role of Regulatory Affairs in the …

https://www.northeastern.edu/graduate/blog/regulatory-affairs-in-medical-device-industry/

Regulatory affairs professionals serve a critical function throughout a medical device’s product …

Medical Device Regulatory Changes Occurring in 3 Key …

https://www.certara.com/blog/medical-device-regulatory-changes-geographics/

Class C devices have until May 2026. Class B and Class A Sterile devices have until May 2027. Class A Non-Sterile devices are under IVDR regulations as of …

Medical Device Regulatory Submissions

https://medicaldeviceacademy.com/medical-device-regulatory-submissions/

Medical Device Academy can help you with medical device regulatory submissions including: 510(k) Submissions; De Novo Classification Requests; Pre-Sub Meeting …

Regulated Product Submission | International Medical …

https://www.imdrf.org/working-groups/regulated-product-submission

Regulated Product Submission | International Medical Device Regulators Forum Regulated Product Submission Working Group Chair (s) Patrick Axtell Food and …

FDA Submissions and Registration for Medical Device …

https://www.emergobyul.com/services/fda-submission-medical-devices-and-vitro-diagnostics-ivds

Commercializing your medical device or IVD in the US market requires submitting registration applications to the US Food and Drug Administration (FDA). The content of …

Regulatory Submissions for Medical Devices | dicentra.com

https://dicentra.com/medical-devices/regulatory-submissions

Regulatory Submissions for Medical Devices Speak With A Specialist Regulatory Submissions for medical devices differ depending on the jurisdiction and the …