Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling part7

FDA Review of Reprocessing Instructions and

Documentation of Reprocessing Method Validation in Submissions

All cleaning, disinfection, and sterilization methods should be validated, and validations should
be completed prior to submission of your pre-market submission. Your reprocessing instructions
should reflect the validated methods. FDA will review the reprocessing instructions included in

the labeling when we review premarket submissions for reusable medical devices. If the

proposed labeling includes reprocessing instructions that do not provide adequate directions for use, FDA will communicate this to the submitter of the premarket submission. In response, the submitter may provide revised labeling or provide a rationale (and any supporting
documentation) to explain why the labeling is adequate.

The documentation to be submitted to FDA for the validation of your reprocessing process and
instructions will depend upon the type of premarket submission and device type, as described
below.

A.     Documentation in 510(k)s

Review of Reprocessing Instructions

All 510(k)s must include proposed labels and labeling sufficient to describe the device, its intended use, and the directions for its use. 21 CFR 807.87(e).  For a reusable medical device as defined in the scope of this guidance, FDA interprets this to include
reprocessing instructions. Validation of the reprocessing instructions should be completed prior to submission of a 510(k).

When evaluating a 510(k), FDA generally compares the labeling for the legally marketed
predicate device to the proposed labeling for the new device. A description of FDA’s
510(k) decision-making process is described in FDA’s guidance The 510(k) Program:
Evaluation Substantial Equivalence in Premarket Notifications [510(k)]
(http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/Guidanc
eDocuments/UCM284443.pdf#page=30). As part of this evaluation, differences in
proposed labeling, among other product differences, can impact the assessment of
whether two devices are substantially equivalent. However, reprocessing instructions for
some older, legally-marketed, reusable devices may not be consistent with state-of-the-art
science and therefore may not ensure that device is clean, disinfected, or sterile.  This
may cause those devices to be adulterated under section 501(c) of the FDCA because its
purity or quality fall below that which it purports or is represented to possess, or to be
misbranded under section 502(f) of the FDCA because its labeling does not bear adequate
directions for use or under section 502(j) of the FDCA because it is dangerous to health,
among other possible violations. This should be taken into account when preparing
reprocessing instructions as part of a 510(k) submission.

Consistent with standard operating procedures for review of premarket submissions, if
post-market experience indicates potentially unsafe reprocessing for a particular
reprocessing method, FDA may suggest that proposed instructions utilizing such method
for a device under review be changed to address the need for improved reprocessing
methods to avoid adverse events of the type reported and violations of the type discussed
in the preceding paragraph.⁵

Review of Validation of Reprocessing Instructions

FDA has identified a subset of medical devices that pose a greater likelihood of microbial
transmission and represent a high risk of infection (subclinical or clinical) if they are not
adequately reprocessed.  This identification is based on knowledge gleaned through
MDRs; recalls; periodic outbreaks of microbial transmission or patient infection reported
in the literature or media; reports provided by the Centers for Disease Control (CDC), the
Veterans Administration (VA), and other health care settings; and manufacturer-initiated
surveillance studies. These device types are listed in Appendix E. The 510(k)s for these
devices should include protocols and complete test reports of the validation of the
reprocessing instructions for FDA review, so that FDA has the information it needs to
evaluate substantial equivalence.⁶ This includes validation of the cleaning instructions as
well as the disinfection or sterilization instructions. The reprocessing validation data
should demonstrate that the proposed reprocessing instructions will reprocess the subject
device at least as well as the reprocessing instructions for the predicate device..

For reusable medical devices not identified in Appendix E, FDA does not expect a
complete report of the validation of the reprocessing instructions to be included in a
510(k) submission. FDA staff may request these data, which the manufacturer should
have on file in accordance with 21 CFR Part 820, if submission of validation data is
recommended in a device-specific guidance or as needed to evaluate substantial
equivalence.

B.      Documentation in PMAs, HDEs and De Novo Requests

A PMA, HDE or de novo request should include the protocols and complete test reports of the validation of the reprocessing instructions in the manufacturing and design section. FDA intends to review the reprocessing validation data in the same manner as the other manufacturing and design data.

C.     Documentation in IDEs

An IDE application must include a report of all prior clinical, animal, and laboratory

testing of the device as part of the report of prior investigations.⁷ We interpret this to

include a summary of the validation testing of the reprocessing instructions.  Because an
approved IDE is not exempt from design controls under 21 CFR 820.30, we recommend
that validation of the reprocessing instructions be complete at the time of submission of
an IDE.

FDA intends to appropriately consider the extent of the data needed prior to the initiation
of clinical studies to document the safety of the recommended reprocessing instructions
for the device.