Page 253 - Assurance of Sterility for Sensitive Combination Products and Materials

230 Assurance of sterility for sensitive combination products and materials

• Established B methods are those for which there is a history of safe and
effective use, albeit a relatively shorter one, and for which there are no
dedicated, FDA-recognized, consensus standards. In short, the Agency
has confidence in the safety and effectiveness of a specific process with
clearly defined, discrete parameters, and not necessarily all permutations
of that method.
• Novel methods are those for which there is inadequate information to
conclude that the process is effective to support a sterile label claim, or
to assure that processed devices are safe and effective for its intended use.
The evaluation of the validation data will likely help the Agency ascer-
tain the effectiveness of the proposed process.

9.4.2 Content recommendations for 510(k)s
The information that should be included within a 510(k) submission has
evolved from that specified in the earlier versions of this guidance (1990
and 2002), but the basic areas of documentation have not changed. Two sig-
nificant areas of expansion are evident in the 2016 guidance; the guidance
now recommends that sufficient information be provided to ensure that the
Agency can identify the sterilization method category, and to ensure that
bacterial endotoxin pyrogenicity concerns are adequately addressed.
The information of interest to the Agency at the time of submission
covers five areas. It is recommended that submissions include:
1. A description of the sterilization method. Guidance is significantly ex-
panded in this section, recommending submission of a more specific
description of the sterilization method to help the Agency ascertain the
method category. Additionally, the inclusion of information on the radi-
ation dose if that method is to be used, or sterilant residuals information
if a chemical sterilant is to be used, is recommended.
2. A description of the method used to validate the proposed cycle, as well
as citations for all relevant and/or dedicated FDA-recognized consensus
standards. The Agency recommends that applicants use FDA-recognized
consensus standards for all general process validation testing, where
available. A current list of these standards is available at https://www.
accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm.
3. The SAL specification. While a majority of medical devices are im-
−6
−3
parted with a maximal SAL of 10 , a maximal SAL of 10 may be
sufficient for some devices that are intended to contact only intact skin.
The guidance specifically states: “For questions related to alternative SALs,
we recommend direct consultation and pre-submission meetings with FDA”