Contains Nonbinding Recommendations
sterilized by the user or to be used without sterilization – submission of a new 510(k) is
likely required. Submission of a new 510(k) is also likely required if a device originally
provided non-sterile is modified to be provided sterile.
If the answer to this question is yes, submission of a new 510(k) is likely required. If the
answer is no, proceed to B3.2.
B3.2 Could the change significantly affect the performance or biocompatibility of the
device? Changes in the method of sterilization, cleaning, or disinfection have the
potential to change material or performance characteristics of a device. This is
particularly true of the properties of polymeric materials or surface coatings, resorbable
materials, or animal-derived materials. When manufacturers make changes in
sterilization, cleaning, or disinfection methods, they should consider whether the
properties or specifications of the device could be significantly affected.
To determine whether the cleaning, disinfection, and/or sterilization change could
significantly affect device performance, the manufacturer should consider known
information on the sterilization, cleaning or disinfection method, its parameters, and the
material being sterilized, cleaned, or disinfected, and determine if there are any new or
significantly modified existing risks associated with using the proposed method and its
parameters with the device’s materials of construction. If there are new or significantly
modified existing risks (see Section E), this likely indicates that the change could
significantly affect the device’s safety or effectiveness. Note also that if verification
and/or validation of the new methods show any unexpected results, manufacturers should
re-evaluate whether submission of a new 510(k) is required (see B5.4).
Cleaning, disinfection, and/or sterilization changes may also affect the biocompatibility
of a device. For instance, changes to an ethylene oxide sterilization process may leave
increased ethylene oxide residuals on the device surface, or changes to a cleaning process
may incorporate chemicals that are inappropriate for use with a patient-contacting device.
Manufacturers should consider whether sterilization, cleaning, or disinfection changes
could significantly affect the biocompatibility of their device. If a manufacturer
determines their cleaning, disinfection, or sterilization change could significantly affect
the performance or biocompatibility of the device, submission of a new 510(k) is likely
required. Otherwise, it is unlikely submission of a new 510(k) is required as a result of
this type of change.
B4. Is there a change in packaging or expiration dating? If yes, proceed to B4.1.
B4.1 Is the same method or protocol, as described in a previously cleared 510(k), used to
support the change? Generally, changes in device packaging or changes in the
expiration date for use of a device do not require submission of a new 510(k). FDA relies
on the QS regulation (21 CFR Part 820) to reasonably assure the safety and effectiveness
of devices with these types of changes. This is true whether or not the manufacturer
applies an expiration date because of package integrity considerations, e.g., sterility, or
because of a finite shelf-life of the device. However, where methods or protocols that are
not described in a previously cleared 510(k) are used to support new package integrity or
shelf-life claims, submission of a new 510(k) is likely required. FDA recognizes that
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