FDA nixes GUDID submission requirements for class I consumer healthcare devices

Regulatory NewsRegulatory News | 14 October 2021 |  By 

Manufacturers of class I medical devices considered to be consumer healthcare products will get a reprieve from complying with the US Food and Drug Administration’s (FDA) Global Unique Device Identification Database (GUDID) submission requirements under a draft guidance issued on Wednesday.
Under the agency's unique device identification (UDI) compliance policy guidance issued in June 2020, class I devices, other than implantable, life-supporting, and life-sustaining devices, will be subject to standard date formatting, UDI labeling, and GUDID data submission requirements no earlier than 24 September 2022. However, in the draft guidance, which will revise and supersede Section III of the compliance policy when finalized, FDA explains that it does not plan to enforce GUDID submission requirements for consumer healthcare products, though it still plans to enforce standard date formatting and UDI labeling requirements for such devices after 24 September 2022.
“This draft guidance explains that there are certain class I devices for which FDA does not intend to enforce GUDID submission requirements under § 830.300 and describes how a labeler of a class I device can determine if its device is considered a consumer health product,” said FDA’s announcement.
Makers of other types of Class I devices will still have to comply with the labeling rule by September 2022, as specified in a draft guidance issued in June 2020. (RELATED: Guidance: FDA holds off on enforcing certain UDI requirements, Regulatory Focus 30 June 2020)
The agency has determined that other types of class I devices “may pose greater risks to public health and, based on FDA’s analysis, GUDID data may be more important to monitoring the safety of these devices.” Such devices include class I reserved devices, which are not exempt from the 510(k) premarket notification process, restricted devices, and devices distributed to healthcare facilities and intended for use by healthcare professionals only, in addition to implantable, life-supporting, and life-sustaining devices.
Yet for consumer healthcare products, FDA said that GUDID submissions for these devices is “burdensome to stakeholders” given the “frequent changes to the UPCs serving as the UDIs for these devices.”
FDA defines “consumer health products” as “510(k)-exempt class I devices that are exclusively sold directly to consumers over-the-counter in both brick-and-mortar and online stores. These devices are typically labeled with a UPC, which may serve as the UDI for class I devices (21 CFR 801.40(d)).”
This announcement was prompted by CDRH’s evaluation of “high-level” medical device reporting as well as historical class I recall data. The agency noted that GUDID information “may be less important” in evaluating deice safety for consumer healthcare products.
FDA issued a final rule on 24 September 2013 requiring medical devices to be identified with a unique device identifier for safety purposes and to track them through the distribution chain to the end user. A series of phased in implementation dates followed. The rule went into effect for class III devices in 2016 and for life-supporting and life-sustaining devices in 2015. Class II devices had to comply by 2018.
Originally, class I and unclassified devices had to comply with UDI labeling by 2018, yet FDA extended the date for complying with the UDI labeling rule by two years, until September 2020. (RELATED: Class I and Unclassified Device UDIs: FDA Pushes Back Enforcement Dates by 2 Years, Regulatory Focus 2 November 2018).  This was delayed again until September 2022.
The Consumer Healthcare Products Association (CHPA) said that it is reviewing the guidance. “CHPA’s regulatory team is taking time to carefully review and consider today’s draft guidance and discuss with members. At first glance, we’re delighted to see that FDA is proposing to eliminate the current compliance date of Sept. 24, 2022, for GUDID data submissions for Class I devices considered consumer health products.”
FDA’s UDI guidance
FDA’s announcement


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Tags: devices, FDA, GUDID, UDI, US

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