market access market access MAY/09/JUNE

market access
Medical
but a closer look at the program’s history and rules
might reveal other reasons for the small numbers.
By October 2003, the FDA met its objective to initially
accredit 15 third-party inspection services. In the following
years, another inspection service was added
to that list. Yet, slow progress was made to qualify
individual inspectors/auditors. Today, only eight of the
16 accredited third parties are operational and offer
independent inspections. Of those eight APs, four are
located in the United States.
Apparently, each auditor must follow current program
rules by participating in three joint inspections with the
FDA. The demand for joint inspections far exceeds the
number of inspections offered. In fact, the FDA assigns
the inspections to AP’s by a random draw, which can
decrease the odds of fulfilling the required number of
joint inspections.
Also working against the third parties was the availability
of training opportunities. Joint inspections are
dependent on whether device manufacturers volunteer
to host one. Ultimately, few manufacturers chose to do
so. Additionally, training was limited by the availability
of FDA performance inspectors who must monitor AP
auditors during joint inspections. The limited availability
of training inspections made it difficult for AP’s to plan
auditor qualifications, which subsequently affected the
FDA’s ability to offer third-party inspection services.
maY/09/juNe 1
What is the FDA’s Third Party Inspection Program and pMAP? (continued)
ConTInUEd on PAgE 13
Another reason for the low participation in the program
might be the restrictive eligibility requirements. To
begin with, certain device manufacturers are excluded
from participating:
• Those who have not been inspected by the FDA
(baseline inspection).
• The last inspection has been qualified as OAI (Official
Action Indicated).
On top of this, the AP must be accredited or recognized
by the country where the manufacturer must or intends
to market a device. A quick view of the FDA’s website
shows that some AP’s appear to be recognized in just
a few countries. In one example, an AP listed on the
FDA’s website is recognized only in Norway.
Further, the pMAP program has outlined an even narrower
list of eligibility requirements for manufacturers.
Audits not accepted for the pMAP program include:
• Initial ISO 13485:2003 registration audits under
CMDCAS.
• Transfer of registration from one audit organization/
registrar to another.
• Audits to support an extension to the existing scope
of registration.
• Special “for-cause” audits (e.g., re-audits to followup
on major non-conformities).
Finally, these programs are designed so that device
manufacturers can clearly see the benefits and advantages
to taking part. However, participation appears to
require a “mind-set” adjustment regarding how to deal
with FDA inspection and procedures.