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Resubmitting a 510(k) is More Than a Regulatory Decision

Do changes to your device warrant a 510(k) submission? There are several elements to consider when asking this question: design controls compliance, risk analysis and postmarket surveillance data, among them.

From the initialization of the enactment of the Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act, FDA employees have endeavored to define with greater accuracy those times when a change in a medical device would trigger the requirement that a manufacturer submit a new premarket notification (510(k)) to the Agency. To offer greater clarification, FDA recently released draft guidance on this topic.

As it currently stands, the regulatory criteria state that a premarket notification must be submitted when:

  • The device could be one that your company currently has in commercial distribution or is reintroducing into commercial distribution, but which is about to be significantly changed or modified in design, components, method of manufacture or intended use
  • A change or modification in the device could significantly affect the safety or effectiveness of the device, e.g., the design, material, labeling, chemical composition, energy source or manufacturing process
  • A major change is made in the intended use of the device

With the advent of ISO 14971, risk management, the decision-making process for re-design, re-submit, re-anything can now be based upon consistent, documented choices that are commonly not qualitative, but in fact, include quantitative paths toward proper compliance.

Explicit risk-based examples of modifications that may require a 510(k) submission include at least the following, singularly or collectively:

  1. Sterilization method
  2. Structural material
  3. Manufacturing method
  4. Operating parameters or conditions for use
  5. Patient or user safety features
  6. Intended Use
  7. Sterile barrier packaging material
  8. Stability or expiration claims
  9. Design
  10. Postmarket surveillance trends that trigger any of the examples above (In other words, either FDA or the submitting company are involved with postmarket surveillance and discover information that drives the device or intended use into a higher risk category, e.g. complaints, adverse events, failures, misuse, etc.)

Bearing this in mind, let's discuss the priorities you should consider in your submission.

The Role of Good Manufacturing Practice Regulation
Enter formal design controls, 21 CFR, Part 820.30. Any guidance on 510(k)s for changes to a marketed device must consider the role that current Good Manufacturing Process (cGMP) Quality System Regulation plays in changes to device design. For some types of changes, FDA continues to find that a 510(k) is not necessary and that reliance on existing cGMP requirements may continue to reasonably assure the safety and effectiveness of the device for human use.