Applying for FDA medical device certification involves several key steps. The specific process can vary depending on whether you are submitting a 510(k) notification, a Premarket Approval (PMA), or a De Novo classification request. Here is a general overview of the steps for each type of submission:

1. 510(k) Notification

1. Determine Device Classification:

   • Confirm if the device requires a 510(k) submission and identify the appropriate regulatory pathway.

2. Identify Predicate Device:

   • Select a legally marketed predicate device that is similar in intended use and technological characteristics.

3. Prepare Documentation:

   • Device Description: Provide detailed information about the device’s design, components, and intended use.
   • Indications for Use: Clearly state the device’s intended purpose.
   • Technological Characteristics: Compare the device with the predicate, including similarities and differences.
   • Performance Data: Include data from bench testing, clinical studies, or other performance evaluations.
   • Labeling: Draft labeling materials, including instructions for use, user manuals, and any safety warnings.

4. Compile Submission:

   • Complete the 510(k) form (FDA Form 3514) and compile all required documentation.

5. Submit 510(k):

   • Submit the 510(k) application electronically through the FDA’s Electronic Submission Gateway or via paper if applicable.

6. FDA Review:

   • The FDA will review the submission, and may request additional information or clarification.

7. Respond to FDA:

   • Address any additional information requests or questions from the FDA.

8. Receive FDA Clearance:

   • If the FDA determines that the device is substantially equivalent to the predicate, you will receive 510(k) clearance.

2. Premarket Approval (PMA)

1. Determine Device Classification:

   • Verify that the device requires a PMA based on its risk classification.

2. Conduct Clinical Trials:

   • Perform clinical trials to gather data on the device’s safety and effectiveness.

3. Prepare Documentation:

   • Device Description: Detailed information about the device’s design, components, and intended use.
   • Clinical Data: Results from clinical trials demonstrating safety and effectiveness.
   • Non-Clinical Data: Bench tests, animal studies, and other non-clinical testing results.
   • Manufacturing Information: Details about the manufacturing process, facilities, and quality control measures.
   • Labeling: Draft labeling materials, including instructions for use and safety information.

4. Compile Submission:

   • Complete the PMA application form (FDA Form 356h) and gather all necessary documentation.

5. Submit PMA:

   • Submit the PMA application electronically through the FDA’s Electronic Submission Gateway or via paper if necessary.

6. FDA Review:

   • The FDA reviews the submission, may request additional information, and may conduct inspections.

7. Respond to FDA:

   • Provide any additional information or clarification requested by the FDA.

8. Receive FDA Approval:

   • If the FDA finds the device to be safe and effective, you will receive PMA approval.

3. De Novo Classification

1. Determine Device Classification:

   • Confirm that the device is novel and does not have a predicate device.

2. Prepare Documentation:

   • Device Description: Provide comprehensive information about the device’s design and intended use.
   • Clinical Data: Include data showing the device’s safety and effectiveness.
   • Non-Clinical Data: Provide bench testing, animal studies, or other relevant non-clinical data.
   • Labeling: Draft labeling materials, including instructions for use and safety information.

3. Compile Submission:

   • Complete the De Novo request form (FDA Form 3881) and prepare the documentation.

4. Submit De Novo Request:

   • Submit the De Novo request electronically through the FDA’s Electronic Submission Gateway or via paper if required.

5. FDA Review:

   • The FDA reviews the submission, may request additional information, and may classify the device as Class I or II.

6. Respond to FDA:

   • Address any additional information requests or questions from the FDA.

7. Receive De Novo Classification:

   • If the FDA grants the De Novo request, the device will be classified as Class I or II, and you can proceed with marketing the device.

In all cases, ensure that the submission is complete, accurate, and adheres to FDA guidelines.

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