FDA’s enforcement policy applies to device types including:
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Non-selective and non-differential culture media
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Non-propagating transport culture media
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Anaerobic transport culture media
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Propagating transport culture media
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Specimen collection devices
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Aerobic transport systems
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Anaerobic transport systems
FDA’s enforcement policy does not apply to media used to inactivate or neutralize viruses which are classified under 21 CFR 866.2950.
Under FDA’s enforcement policy, the agency does not intend to object to the commercial distribution of VTM or PBS/Saline transfer media without 510(k) clearance (where applicable) and compliance to Unique Device Identification (UDI) requirements in 21 CFR Part 830 and 21 CFR 801.20 where certain labeling disclosure requirements are met. The agency also does not intend to enforce the Quality System Regulation (21 CFR Part 820) for manufacturers that conform to ISO 13485:2016 Medical Devices Quality Management Systems Requirements for Regulatory Purposes. To qualify for FDA’s enforcement policy, commercial distributors, and laboratories should ensure that transport media are appropriately designed and validated, notification of validation is sent to FDA by e-mail to CDRH-EUA-Templates@fda.hhs.gov, and that the labeling requirements under 21 CFR Parts 801 and 809 are met. Importantly, FDA has not lifted other requirements, including registration and listing requirements under 21 CFR Part 807, reports of corrections and removals in 21 CFR Part 806, and medical device reporting under 21 CFR Part 803.
FDA also indicated that it does not intend to object to laboratories which are CLIA certified to perform high-complexity testing to develop and use VTM or PBS/saline transport media. Importantly, laboratories seeking to distribute VTM or PBS/saline transport media during the COVID-19 public health emergency are required to comply with the same criteria specified for commercial distributors under this guidance.
Authored by Randy Prebula and Seth Olson
