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FDA draft guidance document may limit patient access to tests
Date:8/30/2011

courage most manufacturers to seek clearance and approval for their RUO and IUO products," said Dr. Lyon. AMP members fear that instead of seeking FDA review, some manufacturers will choose to withdraw RUOs from the clinical market. This has already occurred for many analytes, from blood-borne pathogens to sexually transmitted diseases. This would then create a shortage of supplies to develop laboratory tests, resulting in a scarcity of tests, and ultimately, barriers for patients' access to medically necessary tests.

Dr. Lyon added, "Today we are asking the FDA to consider the downstream implications of the guidance on the supplies and materials for laboratory testing, and allow for circumstances where clinical laboratories can develop tests using RUO and IUO products when no other products are available."

AMP's recommendations include:

1. To avoid the disruption of patient care, carefully consider enforcement discretion or alternative regulatory pathways to address circumstances where no FDA cleared/approved products are available, particularly for those products with limited sales volume.

2. Direct enforcement requirements for 510(k) or PMA submissions toward test kits and test systems.

3. Create a consistent and clear pathway to encourage and facilitate ASR, 510(k) or PMA applications for RUO and IUO products, with a reasonable compliance timeline. The pathway must include flexibility to be responsive to rapidly evolving areas.

4. Accommodations should be made to enable certain reagents such as primer or probe mixes to be sold as ASRs. Alternatively, another regulatory pathway could be designed for products that are too complex to qualify as ASRs but are not full test kits or test systems.

5. Clearly state the scope of the guidance. Clarify which products currently labeled as RUOs and IUOs the guidance covers, e.g., test kits, instruments, software, and reagents.


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Contact: Don Hunt, Lambert, Edwards & Associates
dhunt@lambert-edwards.com
616-233-0500
Association for Molecular Pathology
Source:Eurekalert

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