Firms Provided Third-Party,
Nonclinical Premarket Testing; Agency Review Ongoing
SILVER
SPRING, Md., Sept. 11,
2024 /PRNewswire/ -- Today, the U.S. Food and
Drug Administration issued warning letters to two Chinese
nonclinical testing laboratories, citing both for laboratory
oversight failures and animal care violations that raise concerns
about the quality and integrity of data generated by the labs.
Warning letters were issued to Mid-Link Testing Company Ltd. in
Tianjin, China, and Sanitation
& Environmental Technology Institute of Soochow University Ltd.
in Suzhou, China. The firms
provide third-party testing and validation data services to device
manufacturers for use in their premarket device submissions to the
FDA.
The FDA continues to conduct a rigorous review of data generated
from these test facilities, submitted in premarket submissions, and
does not intend to authorize submissions where the data are
necessary for the FDA to make a marketing authorization decision,
as such data are found to be unreliable. The agency is evaluating
any impact these findings have had on past submissions and will
take action to address any public health risks as necessary.
The agency inspected the firms earlier this year and found
pervasive failures with data management, quality assurance, staff
training and oversight. The findings included the failure to
accurately record and verify key research data, which brings into
question the quality and integrity of safety data collected at the
facilities. These failures could lead to the use of unreliable data
in premarket device submissions. The warning letters also note
violations related to test animals. One firm is cited for failing
to provide adequate care for the animals, and both firms failed to
provide adequate identification and recording of the animals used
in the labs' testing.
"The medical device industry must be built and sustained on
safety, effectiveness and quality," said Owen Faris, Ph.D., acting director of the Office
of Product Evaluation and Quality in the FDA's Center for Devices
and Radiological Health. "The FDA will take action to protect
patients, consumers and the medical device supply chain from
quality failures and violative practices. We strenuously remind
industry of their responsibility and accountability for all data
included in their submissions, which are required to comply with
federal law."
Earlier this year, the agency alerted the medical device
industry to third-party testing lab concerns with device
submissions and stressed the need for firms to carefully review any
data from testing that the firm itself did not perform. The FDA
will continue to evaluate submissions and take action where
appropriate, as some devices affected may be currently on the
market. The FDA will continue to focus on testing data failures,
including from third-party testing labs.
Nonclinical laboratory studies are experiments in which test
articles are studied prospectively in test systems (such as
animals, plants and microorganisms or subparts thereof) under
laboratory conditions to determine their safety. While a device
sponsor may use a third-party lab for nonclinical studies, doing so
does not relieve the device sponsor of the responsibility to ensure
the accuracy of data included in their regulatory submission.
The FDA has requested that the recipients of the FDA warning
letters notify the agency of their corrective actions to be taken
within 15 working days of receiving the letters.
Additional Resources:
Media Contact: Audra
Harrison, 301-908-6101
Consumer Inquiries: Email, 888-INFO-FDA
The FDA, an agency within the U.S. Department
of Health and Human Services, protects the public health by
assuring the safety, effectiveness, and security of human and
veterinary drugs, vaccines and other biological products for human
use, and medical devices. The agency also is responsible for the
safety and security of our nation's food supply, cosmetics, dietary
supplements, radiation-emitting electronic products, and for
regulating tobacco products.
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SOURCE U.S. Food and Drug Administration