electronic Submission Template And Resource

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ASCA eSTAR Form
For devices that are part of the ASCA program

Introduction
This template is intended for use in both constructing the biocompatibility section for a medical device premarket
application/submission that contains testing from an ASCA-accredited test lab, and in being a resource of medical
device premarket regulations. This template is only used for constructing the biocompatibility section that contains
testing from an ASCA-accredited test lab, not the entire application or submission. Once complete, this section should
be included with the rest of your application or submission.

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Key
A Red Bar indicates the associated required question, or a required question in that section, wasn't answered.
A Green Bar indicates the associated required question, or all required questions in that section, was answered.
A Grey Bar indicates the associated question is optional. Green and Grey Bars act as left borders when present.

Blue Help Text Buttons when clicked display regulatory information pertaining to the question or section
heading they immediately follow. Assistive Technology (AT) users including text to speech, will hear "Help Text
Button." If activated , the help text windows will open, and can be closed by tabbing to the OK key and pressing return.

I Hover Text I Hover text displays information about your application, such as the date an attachment was attached , or, if

the section corresponds to an IMDRF harmonized section, the hover text will display the chapter number of the
IMDRF Table of Contents.
Form Approved: 0MB Control No. 0910-0889
0MB Expiration Date: XX/XX/20XX

PRA Statement

This section applies only to requirements of the Paperwork Reduction Act of 1995.

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 1 hour per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burd en, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
[email protected]
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid 0MB number."