Regulatory Focus™ > News Articles > FDA Releases Draft Guidance on 510(k) Submissions

FDA Releases Draft Guidance on 510(k) Submissions

Posted 26 July 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) has released a new draft guidance for its staff members and industry instructing them on how to assess the safety risks of small-bore connectors submitted through a 510(k) application.

The 26 July document, Draft Guidance for Industry and Food and Drug Administration Staff - Safety Considerations for 510(k) Submissions to Mitigate the Risks of Misconnections with Small-bore Connectors Intended for Enteral Applications, specifically applies to small-bore connectors intended for enteral, as opposed to parenteral, applications.

FDA notes the connector ports are often standardized, which can lead to devices mistakenly being connected to other, non-related devices, resulting in "serious and sometimes fatal consequences to patients."

The agency pointed to a 2006 report by the accrediting body The Joint Commission that found many misconnections were the result of luer connectors-"small devices used in the connection of many medical components and accessories." The connectors were blamed in a number of accidents, including IV lines being connected to epidural lines, bladder irrigation solutions being connected to IV tubing, infusion lines being connected to catheters, and IV solutions administered with blood administration sets and visa-versa.

The report quoted a fellow researcher as saying, "A well-designed device should prevent misconnections and should prompt the user to take the correct action."

The issues are not unknown to FDA, which had sent an alert to health providers in 2010 about the potential for luer-lock mix-ups. Shortly thereafter the agency asked medical device manufacturers to conduct their own assessment of the devices and provide ways to reduce the risk of misconnections.

FDA's draft guidance now recommends manufacturers submit 510(k)s with data demonstrating that "each proposed enteral connector is physically incompatible with non-enteral devices," and similarly recommends they submit a declaration of conformity to ISO 80369-1.

The guidance also notes FDA will no longer accept color-coding or tagging as being sufficient to deter compatibility issues by themselves, and applicants will be required to perform a risk assessment to show a mitigation of risk.

In addition, "although usability and/or human factors testing is not usually required, applicants can submit evidence that these tests were performed within their 510(k)," explained FDA. "Future proprietary connectors may need usability and/or human factor testing to confirm there is no unacceptable risk, as described in AAMI/ANSI HE75:2009."

Comments on the draft guidance are due by 26 October.


Read more:

FDA - Draft Guidance for Industry and Food and Drug Administration Staff - Safety Considerations for 510(k) Submissions to Mitigate the Risks of Misconnections with Small-bore Connectors Intended for Enteral Applications

Federal Register - Draft Guidance for Industry and Food and Drug Administration Staff: Safety Considerations for 510(k) Submissions to Mitigate Risks of Misconnections with Small-Bore Connectors Intended for Enteral Applications


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