Originally Published PMPN May 2002
REGULATORY FOCUS
510(k)s for Medical Sterilization
An overview of the draft guidance and requirements for submitting an application.
by Erik Swain, Senior Editor
Firms that make
systems used by healthcare facilities to package and sterilize medical devices
are required to submit a 510(k) application to FDA before marketing them. Now,
FDA’s Center for Devices and Radiological Health (CDRH) has come out with
a draft guidance on what should be included in those submissions.
The document, "Premarket
Notification [510(k)] Submissions for Medical Sterilization Packaging Systems
in Health Care Facilities," was published on March 7, 2002, and can be
viewed at www.fda.gov/cdrh/ode/guidance/1388.html.
Comments must be submitted to the agency by June 5, 2002.
The draft guidance
covers a wide variety of specific recommendations for submitters of such 510(k)
applications. It applies to sterilization wraps, sterilization pouches, sterilization
containers, sterilization trays, and sterilization cassettes, including related
components such as trays, holders, or mats.
It does not apply
to trays and cassettes used only for storage and not sterilization, or packaging
systems used in industrial settings to prepare devices for sterilization for
commercial distribution. Cassettes or trays used as packaging for single-use
devices that will not be reused are also not affected. Furthermore, the draft
does not apply to process indicators printed on a packaging system or incorporated
into a sterilization container system, or packaging intended for aseptically
produced devices.
The submission
should begin with a cover letter and table of contents. The cover letter should
include the trade and classification names of the device, the establishment
registration number of the submitter, the FDA product code, the FDA panel review
code, the classification (Class II in these cases), the name and 510(k) number
of the legally marketed predicate device, and the name, address, and phone number
of a contact person at the submitting firm.
Next should come
a Truthful and Accurate Statement, an Indication for Use Statement, and, if
a Summary of Safety and Effectiveness Information is not being included, a statement
that safety and effectiveness information will be made available to anyone who
requests it. The guidance document contains appendices showing how these should
be worded.
A predicate device
must be identified and the characteristics of the new system must be compared
with it. Comparative elements should include intended use, material composition,
physical properties, chemical properties, configurations and dimensions, air
permeance, and percent of surface perforations. Performance characteristics
must also be compared. These include sterilant penetration, microbial barrier
properties, material compatibility, toxicological properties, shelf life, drying
time, and aeration time. The document further details what information should
be included to support the performance characteristics.
Next comes the
device description, which should include general characteristics of the system
design and manufacturing specifications, including material composition, tolerances,
toxicological properties including sterilant residues, compatibility of the
material with the recommended sterilization processes and cycle parameters,
description of the recommended sterilization processes and cycle parameters,
and the limits of reuse. Then a clear statement of intended use should be made.
If process indicators are included, a checklist found in an appendix to the
document should be used.
The submission
needs to identify any consensus standards that the system meets.
The next portion
of the application should contain verification and validation data for the parameters
listed under the comparison with the predicate device and the description of
the new system. Data for sterilant penetration, package integrity and the maintenance
of it, drying and aeration, material compatibility, and biocompatibility should
be enclosed. Reusable containers and cassettes require additional data on limits
of reuse, cleaning parameters, and proof of meeting original specifications
after processing. The document includes extensive details on what sort of tests
must be performed to obtain this data.
The submission
must also contain proposed labels, labeling, and advertisements sufficient to
describe the system and its intended use and directions for use. The document
lists what information should be included, which may vary depending on what
kind of packaging is involved.
Written comments
on the draft guidance may be submitted to the Dockets Management Branch (HFA-305),
FDA, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Electronic comments may
be submitted at www.fda.gov/dockets/ecomments.
For further information, contact Chiu S. Lin, CDRH (HFZ-480), FDA, 9200 Corporate Blvd., Rockville, MD 20850, 301/443-8913.
Copyright ©2002 Pharmaceutical & Medical Packaging News
