FDA has issued draft guidance to help medical device manufacturers understand when a change to a previously cleared 510(k) device may require a new premarket notification submission. According to the agency, most packaging changes do not require a new 510(k). But there are some areas you should study closely.
In the draft, FDA writes that “generally, changes in device packaging or changes in the expiration date for use of a device do not result in the need to submit a new 510(k)” and are “within the scope of the Quality System regulation.”
However, if you are basing new package integrity or shelf-life claims on “methods or protocols not described in the original 510(k),” you may need to submit a new 510(k), reads the draft.
Another area to watch is sterilization. If the sterility assurance level (SAL) remains “better than 10-6, a new 510(k) submission is not necessary; only if the SAL is less than 10-6 should a 510(k) be submitted,” writes FDA in the draft. Changing from one method to another does require a new 510(k), however. Changing the device’s status from sterile to nonsterile also requires a new submission. But other changes that do not “significantly affect the safety or effectiveness of the device” may not. You will need to document that any sterilization change does not affect the “important properties and specifications of the device.”
Labeling changes require careful consideration. FDA writes in the draft that “changes in device labeling often pose the most difficult questions to be addressed by device manufacturers when deciding whether a new 510(k) submission is necessary. Frequently, an apparently subtle change in a device’s labeling can have a significant impact on the safe and effective use of the device.”
In this draft, FDA advises companies to consider the following questions:
1. Does the change affect the indications for use? FDA writes that it “views most labeling changes that affect the indications for use . . as major changes to the intended use of a device that warrant the submission of a 510(k).” Four common labeling changes are pointed out as usually requiring submission of a 510(k):
- Changes that allow reuse of devices previously labeled “single use only.”
- Changes from prescription to over-the-counter (OTC) use.
- Changes from prescription use in a clinical setting to prescription use in a home setting (home use devices).
- Changes from general patient populations to specific patient populations (e.g., changes from an undefined patient age group to a pediatric population).
2. Does the change affect the contraindications for use, such as adding or deleting a contraindication? FDA wants to review “all changes in the labeled contraindications for device use,” but it does recognize that “the addition of a contraindication based on new information is important to public health and should be implemented immediately,” it says in the draft. So manufacturers are “encouraged to add new contraindications to labeling of cleared devices and to notify existing device users of such contraindications as expeditiously as possible whenever a pressing public health need arises. The new labeling should be submitted to FDA as part of a new 510(k) that is prominently labeled ‘change being effected’ (CBE). Manufacturers may market the device with the modified labeling unless otherwise notified by FDA.” Manufacturers that delete a contraindication should submit a new 510(k) prior to effecting the change because this type of labeling change expands the indications for use, FDA writes.
3. Is it a change in instructions for use? FDA writes in the draft that “if the labeling change instructs the user to use the device in a different fashion from that originally cleared,” the agency considers it a major change in intended use that require submission of a 510(k).
4. Is it a change in warnings or precautions? FDA writes that “submission of a new 510(k) for labeling changes that add warnings or precautions is generally unnecessary; however, manufacturers are encouraged to discuss these situations with FDA.” But labeling changes that delete warnings or precautions “are likely to warrant new 510(k) submissions.”
Packaging professionals should be familiar with all previously cleared medical device submissions before instituting any change. There is a chance you can make your packaging change without a new 510(k). But boost your confidence with careful collaboration across your design, manufacturing, and regulatory teams.