When a manufacturer makes a change to an existing medical device. It is important to determine whether that change requires a new 510(k) submission. Submitting a new 510(k) for a change to an existing device ensures that the device remains safe and effective for its intended use.
Require a New 510(k) ?
The FDA provides guidance on when a new 510(k) submission is in requirement for a change to an existing device. In general, a new 510(k) is required when the change significantly affects the safety or effectiveness of the device or when the change introduces a new indication for use.
Examples of changes that would require a new 510(k) submission include changes to the device’s design, material, energy source, and labeling. Changes to the device’s performance or specifications. May also require a new 510(k) submission if they could impact the device’s safety or effectiveness.
Conversely, changes that are consider to be minor may not require a new 510(k) submission. For example, changes to the device’s manufacturing process or changes to correct typographical errors in labeling may not require a new submission.
The FDA provides additional guidance on determining whether a change is considered major or minor. Manufacturers should evaluate the potential impact of the change on the device’s safety and effectiveness and document the rationale for their decision.
New 510(k) Submission: Time of Need?
If a new 510(k) submission is required, the manufacturer should submit the new application at least 90 days before the device is marketed. This allows the FDA to review the submission and determine whether the device is safe and effective for its intended use.
In certain circumstances, the FDA may require a shorter review period. For example, if the device is intending to address an unmet medical need or is being in a public health emergency. The FDA may expedite the review process.
- Submitting a new 510(k) at least 90 days before marketing ensures FDA review.
- FDA may require a shorter review period in some circumstances.
- Shorter review period may apply for devices addressing unmet medical needs.
- Shorter review period may apply for devices used in public health emergencies.
- Expedited review process allows faster availability of medical devices to patients.
New 510(k) Submission Must include?
A new 510(k) submission for a change to an existing device should include all relevant information about the change. Including the design and performance specifications of the modified device, data from testing and validation studies, and updated labeling and instructions for use.
The submission should also include a comparison of the modified device to the original device. Highlighting the differences between the two and explaining how the changes impact the device’s safety and effectiveness.
In addition, the submission must include any information about potential risks associating with the change and how those risks mitigate. The manufacturer should also document any testing or validation that was in conducting. To demonstrate the safety and effectiveness of the modified device.
What Happens After a New 510(k) Submission?
After a new 510(k) submission is thought to be in requirement. The FDA will review the application and determine whether the modified device is safe and effective for its intended use. If the FDA determines that the device is safe and effective, it will issue a new 510(k) clearance letter.
If the FDA determines that the modified device is not safe and effective. It may request additional information from the manufacturer or require the manufacturer to conduct additional testing or validation studies. In some cases, the FDA may also require the manufacturer to submit a premarket approval (PMA) application. Instead of a 510(k) application.
Submitting a new 510(k) for a change to an existing medical device is an important part of ensuring the safety and effectiveness of the device. Manufacturers should carefully evaluate any changes to their devices and determine whether a new submission is apt. By following FDA guidance and submitting complete and accurate applications. Manufacturers can ensure that their modified devices are safe and effective for patients.