Medical Device Regulatory Approval Process

Step 3: Pathway to Approval | FDA

https://www.fda.gov/patients/device-development-process/step-3-pathway-approval

Federal Food, Drug, and Cosmetic Act, section 513, established the risk-based device classification system for medical devices. Each device is assigned to one of three regulatory classes:...

Overview of Device Regulation | FDA

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

Medical Device Listing - 21CFR Part 807 Manufacturers must list their devices with the FDA. Establishments required to list their devices include: …

Premarket Approval (PMA) | FDA

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

FDA Approval Process for Medical Devices: Step-by …

https://blog.clevercompliance.io/medical-product-compliance/fda-approval-process-for-medical-devices-step-by-step-guide/

US FDA Approval Process for Medical Devices - Emergo

https://www.emergobyul.com/resources/us-fda-registration-process-medical-devices-and-ivds

Determine the classification of your medical device or in vitro diagnostic (IVD) …

510(k) Submission Process | FDA

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

Starting October 1, 2023, all 510 (k) submissions, unless exempted (as described in Section VI.A of the final guidance, Electronic Submission Template for …

Is the FDA De Novo Pathway the Right Medical Device …

https://sterlingmedicaldevices.com/thought-leadership/is-the-fda-de-novo-pathway-the-right-medical-device-regulatory-pathway-for-you/

What is a predicate device? It is a device already on the market that is “substantially equivalent” to the device that is to be submitted for approval. For example, …

Common Medical Device Regulatory Compliance Roadblocks

https://www.regdesk.co/common-medical-device-regulatory-compliance-roadblocks/

The regulatory approval process for medical devices can be slow and bureaucratic, leading to significant delays in bringing new products to market. This can be …

Regulations and Approval/Certification Process of …

https://www.pmda.go.jp/files/000226675.pdf

There are two regulatory authorities responsible for regulation of medical devices in Japan, MHLW (Ministry of Health, Labour and Welfare) and PMDA. MHLW is responsible …

Singapore Regulatory Approval Process for Medical …

https://www.emergobyul.com/resources/singapore-regulatory-approval-process-medical-devices

The medical device approval process in Singapore explained Step 1 Medical Devices in Singapore are governed by the Health Sciences Authority (HSA). Determine the classification of your medical device …