Look especially at
questions 2 & 3 referenced from the Policy Guidance Help System.
The safest bet is to contact your digital unit manufacturer
review what printers were approved in the PMA (premarket
process for your unit. The regulations don't address printers, but the
RECOMMEND (not require) that you use printers approved by your unit
So, rather than an issue of minimum resolution, printer
technology or FDA approval, it's an issue of
the image receptor manufacturer approves.
Referenced from the Policy Guidance Help System:
Other Modalities Quality Control Tests
900.12(e)(6): Quality Control tests — other
modalities. For systems with image receptor modalities other
than screen-film, the quality assurance program shall be
substantially the same as the quality assurance program
recommended by the image receptor manufacturer, except that the
maximum allowable dose shall not exceed the maximum allowable
dose for screen-film systems in paragraph (e)(5)(vi) of this
Question 1: What are the required quality
control tests for new mammographic modalities?
Mammography systems with image receptor modalities other than
screen-film must undergo periodic quality control tests
following procedures that are recommended by the manufacturer of
the mammographic modality. As is the case for screen-film QC,
the facility must keep records of these tests and all applicable
corrective actions for the longer of: last 12 months or since
the last annual inspection which verifies compliance, or until
the test has been done two additional times at the required
frequency. 21 C.F.R. 900.12(d)(2). Regardless of the
mammographic modality, the mean glandular dose delivered during
a single cranio-caudal view of an FDA-accepted phantom must not
exceed 3.0 milligray (mGy) (0.3 rad) per exposure. 21 C.F.R.
900.12(e)(5)(vi). If the test results exceed the action
level, corrective action must be taken within the required time
frames. 21 C.F.R. 900.12(e)(8).
Question 2: Can a facility use printers and
monitors that were not specifically approved as part of its FFDM
FDA recommends that only printers and monitors specifically
approved or cleared for FFDM use by FDA’s Office of Device
Evaluation be used. However, a facility may use other printers
and monitors. Facilities need to ensure that all printers and
monitors used by the facility with its FFDM unit comply with a
quality assurance program that is substantially the same as that
recommended by the FFDM manufacturer and pass the facility’s
accreditation body’s phantom and clinical image review process.
At the current time, no accreditation body reviews soft copy
images so we recommend that the soft copy images be of such
quality that if they were submitted they would pass the
facility’s accreditation body’s phantom and clinical image
Note: Each softcopy and hardcopy mammographic image used for
final interpretation must indicate identifying information (view
and laterality, technologist identification, patient name, etc.)
(21 CFR 900.12(c)(5)).
Question 3: Can a manufacturer hook up a
printer or monitor to its FFDM unit if the printer or monitor
were not part of its original Pre-Market Approval (PMA)?
Manufacturers will need to check the exact wording of their
PMA to see if this is allowed. However, the facility is not
restricted by the PMA and may hook up and use printers and
monitors other than those approved by FDA for use with the
manufacturer's FFDM unit as long as they meet the requirements
specified in question #2.
Question 4: Must a facility perform all the
required QC testing on a laser printer even if the facility is
using only soft copy for final interpretation and is using the
printer only to provide final interpretation quality hard copy
images to patients, their representatives, and health-care
providers or for retention purposes? If not, is the facility
subject to citation during an MQSA inspection?
Yes to both questions. Even if a facility is using the
printer only for these purposes and never actually provides a
final interpretation report based on the hard copy images, it
still must perform all the required printer QC tests at their
appropriate frequencies or, prior to printing clinical images
for patients and health-care providers or for retention,
whichever is less.
Because of a misunderstanding in the professional community
regarding QC testing in these situations, we have not
universally enforced this requirement. However, this guidance
serves to clarify this matter and those facilities that fail to
perform the required QC testing after July 1, 2007 will be
subject to citation.
Question 10: Is there a list that shows the
laser printers that have been cleared for mammography by the
FDA? If not, how can I determine if FDA has cleared a given
laser printer for mammography use?
FDA has cleared many printers for FFDM use through the 510(k)
process, FDA does not keep a list of cleared printers, other
than what is available in FDA’s 510(k) database at
http://www.fda.gov/cdrh/510khome.html#database. You can search
this database by product code, device name, applicant name,
decision date, and other elements, including a simple word
search. Another way to find out whether a particular printer has
been cleared for FFDM use is to check the device’s labeling or
to have the printer manufacturer provide you with written
documentation showing that the printer has been cleared by FDA