market access market access JULY/08/AUG

market access
Medical
• Encourage industry to provide FDA with more data
- Firms may voluntarily submit reports by third
parties assessing conformance with appropriate
international quality systems standards, such as
ISO, which FDA would consider in setting our
inspectional priorities
In addition, Health Canada and the FDA undertook
a cooperative effort to identify those device
manufacturers in the US, who are due for an
FDA inspection in 2008 and at the same time are
registered to ISO 13485 under the CMDCAS program.
Manufacturers who met both criteria received a
mailing with information about the pMAP program
and were encouraged to participate.
Most recently an increase of interest and participation
in the program has been observed. In the Health
Canada CMDCAS RBF (Registration Body Forum)
meeting in May 2008 it was stated that already five
companies have been successfully assessed under
the pMAP process. Both Health Canada and the FDA,
which also participated in this meeting expressed that
they remain committed to the program and agreed that
a sample size of 10 successful pMAP audits would be
considered “sufficient experience” to assess the results
ConTInUeD on pAge 13
JulY/08/aug
Update on FDA’s Third Party Inspection Program and pMAP (continued)
of this pilot program. If the assessment concludes that
multi-purpose audits are valid and acceptable to fulfill
the requirements under the CMDCAS program, then
some of the restrictions for participation might be
eliminated.
Another very promising objective, which came out of
this meeting, is the development of a common audit/
inspection report format. A common report format
would significantly reduce the time needed by the AP/
Registrar to prepare the two submissions and hence
would reduce the additional service fees associated
with AP/pMAP audits.
Who should participate and why?
Manufacturers who are likely to be inspected by the
FDA and who market products in foreign countries will
benefit from participation in the AP and pMAP program
because they will reduce the overall number of audits/
inspections conducted at their establishment and they
will gain more control over the timing and planning of
the audit/inspection.
Manufacturers who in the past have not been inspected
at two year intervals might want to consider an AP
inspection for another reason: Historic data shows
that regularly inspected establishments are more
likely to be found in compliance with the regulations.
By requesting an AP inspection on a regular basis,
manufacturers can increase the confidence in their
quality management system and its conformance to
the US regulations.
Finally, manufacturers that are not currently eligible
under the program, or do not wish to participate at
this time, are encouraged to volunteer to host joint
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