Question of the Month with Comment
MedSun: Newsletter #15, June 2007
How are you handling dated equipment when the expiration date is extended by the manufacturer? A catheterization laboratory manager requested “fresh” carotid stents rather than those on hand, which had expiration dates that had been extended by 1 year, according to a letter from the manufacturer. The risk manager supported the reorder although the materials manager of the institution felt there was no risk in using the extended expiration date stents. What’s your opinion?
From FDA: A review of the manufacturer’s letter extending the expiration date of the “stents” revealed that it was not the shelf life of the stents themselves that was being extended but rather that of the embolic protection system (EPS). [Embolic protection system devices are catheter-based nonimplant devices that are used during stenting and balloon angioplasty procedures. They are used to capture and remove embolic material generated during the procedure, which might otherwise migrate downstream in the blood and cause a stroke or heart attack.] No change to the shelf life of the stent itself was mentioned in the letter.
Because the EPS was cleared for marketing by the Food and Drug Administration (FDA) 510(k) process (see below), it was the manufacturer’s responsibility to determine if extending the shelf life (expiration date) had a detrimental impact on safety or effectiveness. Once that determination was made, the manufacturer was able to change its labeling and notify its customers of the change. No new 510(k) submission was required. Stents and the EPS devices are regulated differently by FDA; as a result, the regulatory process requirements to be followed when extending shelf life for each are different.
FDA Regulation of Stents: Premarket Approval Application
Stents are currently regulated under the Premarket Approval Application (PMA) regulations [21 CFR Part 814.20]. Here, a manufacturer must submit a comprehensive application that demonstrates that the device is safe and effective for its intended use(s). The evidence for this assertion typically includes the results of the sponsor’s laboratory and clinical testing and other detailed supporting documentation. Devices that require PMAs are typically life-supporting, implantable, high-risk devices that often use novel technology, such as silicone breast implants and artificial hearts. With devices that are approved for marketing through the PMA process, an expiration date (shelf life) is included in the device labeling. This shelf life is based on testing results obtained by the manufacturer using a defined testing protocol. Manufacturers can perform additional testing with this protocol to show that the shelf life of the device is longer than that in the approved labeling. If the manufacturer has an approved protocol for shelf-life testing, shelf-life extensions can simply be submitted to FDA in an annual report for the PMA. If the manufacturer does not have an approved protocol, such a change in shelf life would be considered a change in the safety and/or effectiveness for the device and must be reported in a supplement. Such a supplement would then have to be approved by FDA before the manufacturer could market the device with the extended shelf life claim.
FDA Regulation of EPSs: Premarket Notification Procedures [510(k)s]
Unlike stents, EPSs are regulated under the Premarket Notification Procedures 510(k) regulations [21 CFR Part 807.81]. For these devices, the manufacturer must submit a notice that it intends to market a given device and in it show that the device is substantially equivalent to another device (called a predicate) that is already legally on the market in the United States. This notice or application is not as involved as a PMA, and about 90 percent of the medical devices that go to market each year use this process. Devices such as magnetic resonance imaging scanners and digital blood pressure monitors are cleared for marketing by the 510(k) process.
There are no provisions for supplements (that is, changes, updates, or modifications) to a 510(k) submission once it has been cleared. As a result, when changes are made to a 510(k)-regulated device that will affect its safety or effectiveness, a new 510(k) submission is required.
Manufacturers are required to submit prescribed annual reports to FDA for all approved PMA devices that are being marketed (per 21 CFR Part 814.84).
A supplement is defined in 21 CFR Part 814.39(a)(7). It is an additional submission that provides a full explanation of the basis for the change and evidence that the device’s safety and effectiveness are maintained after the change is implemented.
Guidance is available in “Deciding When To Submit a 510(k) for a Change to an Existing Device." Part B9 of this guidance addresses changes to expiration dating and states in part, “Generally…changes in the expiration date for use of a device do not result in the need for a new 510(k).” There are some exceptions to this, so it is best to consult the guidance whenever a change of any kind is made to a 510(k) device.
Deciding When To Submit a 510(k) for a Change to an Existing Device