|
1
|
- Issues Under Current Consideration Regarding “Migration Studies”
- Paul A. Mied, Ph.D.
- FDA Industry IVD Roundtable
- November 10, 2004
|
|
2
|
- A study plan to validate the transfer of:
- a) a manual EIA or NAT assay to
an instrument platform;
- b) a semi-automated assay to a
fully automated assay;
- c) an assay from one instrument
platform to another
- (new, improved, or different
automation).
- This study plan is applicable both to diagnostics and blood screening
tests.
|
|
3
|
- This study plan provides an alternative to clinical trials in restricted
circumstances:
- When it’s essentially the same
assay;
- When the reagents are unchanged;
- When similar technologies are
used;
- When the changes are not
expected to change the performance of the assay.
|
|
4
|
- Relevant guidance documents;
- Dialogues with the companies;
- Dialogues with the statisticians
- – produced a study plan that is high powered and is smaller than clinical trials.
- When companies feel it’s
appropriate, clinical trials
following CDRH guidance remains an available option.
|
|
5
|
- We suggest the manufacturer’s proposal include:
- an adequate sample size (panels);
- testing at several field sites;
- parametric testing with
statistical comparison of quantitative data (correlation coefficient).
|
|
6
|
|
|
7
|
|
