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Information for Manufacturers of Small Bore Connectors and Medical Devices with Connectors

Connectors are important parts of many medical devices. Good connector design is critical to the safe and effective use of these devices. Manufacturers should provide the necessary safeguards to ensure safe use of these devices and products. All manufacturers are encouraged to:

  • Assess the risks of misconnections for these devices
  • Carefully consider both temporary and long-term options to mitigate the risks

General Information for Manufacturers of Small-Bore Connectors and Medical Devices with Small-Bore Connectors Impacted by the ISO 80369 Series of Standards

Manufacturers with an existing 510(k) clearance for devices that use small-bore connectors that have been modified to conform to the relevant ISO 80369 sub-part may refer to information on the FDA webpage, Is a new 510(k) required for a modification to the device?

Manufacturers are also encouraged to follow the Guidance for Industry and FDA Staff - Recognition and Use of Consensus Standards for preparing declarations of conformity.

Even if a 510(k) is not required for a change to an existing device with small-bore connectors, the device remains subject to Good Manufacturing Practice (GMP) requirements (21 CFR 820), including design controls (21 CFR 820.30) and registration and listing (21 CFR 807). Manufacturers' continuing obligations under the quality system regulations in 21 CFR 820 require control of supply and outgoing product for compliance with design specifications. Compliance with these obligations may be evaluated during routine inspections.

Information for Enteral Manufacturers

The FDA's final guidance: Safety Considerations to Mitigate the Risks of Misconnections with Small-bore Connectors Intended for Enteral Applications provides recommendations to manufacturers, FDA reviewers, and others involved in manufacturing devices that use small-bore connectors for enteral feeding and guidance for submitting or reviewing premarket notification submissions [510(k)s] for these types of devices.

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