Involvement of the FDA in the Design and Development of Medical Devices 

The design and development of new medical devices involves several structured phases to ensure the product is safe and compliant with regulations, especially those set by the FDA. In this blog, we will discuss a general outline of the process with a focus on where the FDA comes to play.

1. Planning Phase: The first step is identifying the need for the medical device and understanding the clinical requirements, technical specifications, and market needs. From the beginning, a regulatory strategy is needed- this is where the FDA comes into play. A team determines whether the device has to go through the FDA’s premarket review process (such as 510(k), PMA, or De Novo) based on risk classification¹.

• Design Input: The product specifications are based on the user and the FDA requires that these inputs include safety and performance criteria. During this phase, the potential risks are assessed. This includes identifying hazards, evaluating risks, and determining mitigation strategies. These are all essential for meeting FDA requirements, under ISO 14971².

• Design and Development: engineers design the product, create prototypes and test said prototypes³. If the device is high- risk the FDA will be involved in several stages in your design and development phase, such as, 510k, PMA, IDE.

• Design Verification and Validation: testing is conducted to ensure that the product meets the design specifications, as well as said device meets user needs and intended uses⁴. Validation might also include clinical trials, which must be conducted under IDE. As our team in EMMA knows, IDE requires FDA approval, before testing on human subjects.

• Manufacturing and Production: Once the design is finished, the manufacturing process is created so the device can now be produced in bulk. The FDA ensures compliance of 21 CFR Part 820, which governs medical device manufacturing process⁵.

• Regulatory Submission and Approval: Before the device can be marketed, the EMMA team will make sure the company submits the required regulatory filing, such as 510k PMA and other applicable submissions. The FDA receives these submissions and determines whether the devices are safe and affective⁶.

• Post Market Surveillance: Once it is on the market the FDA requires post-market surveillance to monitor the device’s performance.

In conclusion, FDA’s involvement spans throughout the entire lifecycle of medical devices, from initial regulatory planning, through Post Market Surveillance. This process can definitely be hard and strenuous, and our team at EMMA knows this. The team at EMMA is well versed on FDA filing and making sure your device is compliant. If you are having trouble complying with any of the requirements, please call us at 248-987-4497 or email us at info@emmainternational.com to learn more.

References:

1. U.S. Food and Drug Administration. (2023). Premarket notification [510(k)]. U.S. Food and Drug Administration. https://www.fda.gov/medical-devices/premarket-submissions/premarket-notification-510k
2. U.S. Food and Drug Administration. (2023). Premarket approval (PMA). U.S. Food and Drug Administration. https://www.fda.gov/medical-devices/premarket-submissions/premarket-approval-pma
3. U.S. Food and Drug Administration. (2023). Investigational device exemption (IDE). U.S. Food and Drug Administration. https://www.fda.gov/medical-devices/investigational-device-exemption-ide
4. International Organization for Standardization. (2019). ISO 14971:2019 – Medical devices – Application of risk management to medical devices. https://www.iso.org/standard/72704.html
5. U.S. Food and Drug Administration. (2023). 21 CFR Part 820 – Quality system regulation. U.S. Food and Drug Administration. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820
6. EMMA International. (2025, January 30). The FDA’s role in medical device development and approval process. EMMA International. https://www.emmainternational.com/blog/fda-medical-device-approval