Contract manufacturers and suppliers of components or device accessories are required to comply with current good manufacturing practice requirements outlined in the Quality System Regulation (QSR). The QSR establishes a quality system encompassing design, manufacture, packaging, labeling, storage, installation, servicing, and other aspects of medical device production. The U.S. Food and Drug Administration (FDA) inspects manufacturing facilities, including subcontractors, to verify compliance. Based on inspection findings, the FDA may issue Forms FDA 483, Warning Letters, or Untitled Letters. Noncompliance can result in FDA actions such as facility shutdowns, product recalls, refusal of marketing approvals, legal proceedings, and penalties. Research Use Only (RUO) products and Laboratory Developed Tests (LDTs) have distinct regulatory considerations: RUO products are not subject to standard FDA pre- and post-market controls but must include specific labeling, while LDTs are generally regulated as medical devices but have historically been subject to FDA enforcement discretion.
Centogene N V's Comment on Supply Chain
Contract manufacturers and suppliers of components or device accessories are required to comply with current good manufacturing practice requirements outlined in the Quality System Regulation (QSR). The QSR establishes a quality system encompassing design, manufacture, packaging, labeling, storage, installation, servicing, and other aspects of medical device production. The U.S. Food and Drug Administration (FDA) inspects manufacturing facilities, including subcontractors, to verify compliance. Based on inspection findings, the FDA may issue Forms FDA 483, Warning Letters, or Untitled Letters. Noncompliance can result in FDA actions such as facility shutdowns, product recalls, refusal of marketing approvals, legal proceedings, and penalties. Research Use Only (RUO) products and Laboratory Developed Tests (LDTs) have distinct regulatory considerations: RUO products are not subject to standard FDA pre- and post-market controls but must include specific labeling, while LDTs are generally regulated as medical devices but have historically been subject to FDA enforcement discretion.
Sources:
Centogene N v 's official press releases and regulatory filings; CSIMarket.com's supply-chain research; and the financial filings and press releases of other companies cited in this report.
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