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Use a novel sterilization .pdf

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Related Articles: 1
This copy is for your personal, non-commercial use. For high-quality copies or
electronic reprints for distribution to colleagues or customers, click here or call
+1 (908) 547-2200.

Sterility guidance
“The Gray Sheet” Dec. 15, 2008

Printed by Mr. Norm Rabin, Maetrics LLC

Key Documents: 1

Use A Novel Sterilization Method,
Expect A Pre-510(k) Inspection, FDA
By Elizabeth Orr / Email the Author
Regulatory & Policy News / Word Count: 783 / Article # 01160201010 /
Posted: January 26 2016 5:10 PM

Executive Summary
A guidance document on requirements for sterile devices sets three
categories for sterilization methods and asks submitters to supply the most
detailed information for newly developed sterilization techniques that have
not been fully evaluated by FDA. The agency also says it will not clear a 510
(k) relying on a novel sterilization method without first conducting a facility

A newly finalized guidance document
explains what FDA wants to see in 510(k)
submissions for devices sterilized via a nontraditional method, and makes clear that
the agency plans to inspect manufacturing facilities before clearing a 510(k) for a
device that is sterilized by a novel process.

Click a document title to review.

Topics Covered in
this Article
Click a keyword for related
General Topics
Product Approvals
Post-Market Regulation
Medical Devices

The guidance comes in response to the growing prevalence of sterilization methods
that differ from conventional tactics, FDA said in a Jan. 21 notice
. The guidance
was first issued in draft form on Dec. 12, 2008, and replaces a 2002 sterility review
guidance. (See "Sterility guidance" — "The Gray Sheet," Dec. 15, 2008.)

Pre-510(k) Inspections For Novel Methods
The guidance sets three categories for sterilization methods, each of which carries
slightly different 510(k) requirements. The first, Established Category A, applies to
“methods that have a long history of safe and effective use” such as moist heat, dry
heat, radiation and use of ethylene oxide in a closed chamber.

https://www.pharmamedtechbi.com/publications/the-gray-sheet/42/5/use-a-novel-sterilizati... 1/29/2016


Page 2 of 3

The second, Established Category B, includes “established methods for which there
are no FDA-recognized dedicated consensus standards, but for which published
information on development, validation, and routine control is available.”
Sterilization methods in Established Category B include hydrogen peroxide, ozone
and flexible bag systems.
The final category is that of novel
"We believe inspecting the
sterilization methods, which the guidance
manufacturing facility for
describes as “newly developed methods
for which there exists little or no
devices sterilized using
published information, no history of
these novel sterilization
comprehensive FDA evaluation of
technologies will help
sterilization development, and validation
ensure the safety and
data through an FDA-cleared 510(k) or
effectiveness of these
approved PMA for devices sterilized with
devices," FDA states.
such methods, and no FDA-recognized
dedicated consensus standards on
development, validation and routine
control.” Variations on Category B sterilization methods might be considered novel if
the parameters of the technique differ from what FDA has seen before, the
guidance explains.
Known novel sterilization methods include vaporized peracetic acid, high intensity
light or pulse-light, microwave radiation, sound waves, or ultraviolet light.
However, FDA says that it will not clear a 510(k) for a device that is sterilized via a
novel process without first inspecting the manufacturing facility.
The agency does not typically perform a pre-510(k) inspection as it does before
approving a PMA, and is not allowed to withhold a 510(k) due to a failure to comply
with good manufacturing practices unless FDA finds there is a substantial likelihood
that failure to comply will "potentially present a serious risk to human health." This
case meets that exception threshold, FDA says.
"Failure to assure sterility presents a serious risk to human health because of the
risk of infection," FDA states in the guidance. "We believe inspecting the
manufacturing facility for devices sterilized using these novel sterilization
technologies will help ensure the safety and effectiveness of these devices and
mitigate the risks to human health."

510(k) Requirements Ramp Up
If a 510(k) device is sterilized via a method in either established category, a
sponsor's submission must describe the sterilization method and sterilization
chamber, as well as the sterilization site and the way the sterilization method was
validated. For chemical sterilizers, the maximum amount of chemical residue should
be listed; for radiation sterilizers, the 510(k) should include the radiation dose used.
Pyrogenicity testing for bacteria is required for implants, devices in direct contact
with the cardiovascular or lymphatic systems, and devices labeled non-pyrogenic.
In addition, the 510(k) should include a description of the packaging and explain
how it will maintain sterility.

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For methods in Category B, the submission should also explain whether and how
the sterilizer used was approved or cleared by FDA.
For devices sterilized via a novel method, the 510(k) must include all of the
information required for established methods as well as a comprehensive
description of the sterilization process; the method used to validate the sterilization
cycle; the validation protocol; and sterilization validation data. The submission
should also include any applicable literature. FDA may ask for more information if
necessary, the guidance notes.
The guidance specifically excludes from its scope device sterilizers that are
themselves regulated as medical devices; processes to sterilize devices that
include human or other animal tissue; processes used by reprocessors of singleuse devices; processes used to reprocess devices within health care facilities; and
processes that rely on microbial exclusion or incorporate the use of liquid sterilants.
This copy is for your personal, non-commercial use. For high-quality copies or
electronic reprints for distribution to colleagues or customers, click here or call
+1 (908) 547-2200.
Printed by Mr. Norm Rabin, Maetrics LLC

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