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In a publication in the Federal Register, Vol 72, No 182, 20. Sept. 2007,
pages 53774-53778 the US Food & Drug Administration (FDA) estimates the effort
necessary to implement the requirements defined in 21 CFR 820. The estimate is
broken down quite accurately to the single paragraphs of 21 CFR 820.
The US authority asks industry for feedback on the estimate’s accuracy. The poll
is connected with the Paperwork Reduction Act from 1995. For roughly 9,000 firms
the FDA expects the effort to sum up to three million hours. Interestingly, the
authority also estimates that 650 new companies (marketing medical devices for
the first time) will need 143,000 hours to develop records and procedures for
the CGMP/QS regulation.
Resulting from requirements defined 21 CFR 820, the FDA further estimates that
activities are distributed as follows:
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Requirements related to manufacture specifications, process
controls and „Device History Record“ (DHR) – 40%
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Requirements related to components and acceptance activities
– 20%
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Requirements related to equipment, records, complaints
including directly associated issues as well as labelling/packaging – 25%
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Requirements related to quality audit, traceability,
distribution, and statistics etc. – 15%.
Further information is available in the
CFR Excerpt.
Author:
Sven Pommeranz
On behalf of the European Compliance Academy (ECA)
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