Saludos a todos,
A recent ruling from the FDA's CDRH and my interpretation of the
implication of such ruling....
The following is from the FDAnews Device Daily Bulletin.
"CDRH Requests Electronic Copies
When submitting premarket medical device submissions to CDRH,
manufacturers should include an electronic copy along with their
paper copies. The electronic copy should be created as a PDF and
submitted on a CD or DVD. Clinical data files submitted in support of
the review may be in SAS, XPORT, XML, SGML and Molfile formats, CDRH
says in a new question-and-answer document
(http://www.fda.gov/cdrh/elecsub.html) on submitting electronic
copies. Any submission type [510(k), IDE, PMA, 513(g), Pre-IDE, HDE,
PDP, Emergency Use Authorization and subsequent amendments or
supplements] can be submitted as an electronic copy."
CDRH is "forcing" manufacturers to include an e-submission with the
paper submission.
According to the Part 11 Scope and Application Guidance (August 2003)
third bullet in III.B.2: "Under this narrow interpretation, FDA
considers part 11 to be applicable to the following records....."
"Records submitted to FDA, under predicate rules (even if such
records are not specifically identified in Agency regulations) in
electronic format (assuming the records have been identified in
docket number 92S-0251 as the types of submissions the Agency accepts
in electronic format)."
Then...if this records submitted in electronic format must be
maintaining following Part 11? Is CDRH forcing medical device
manufacturers to maintain such records?
Cheers,
Orlando Lopez
Alpharma Integrated Solutions
olopez@alpharmapr.com
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