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Regulatory Focus™ > News Articles > 12 > AdvaMed, MITA Call for Tweaks to CDRH’s Proposed FY 2019 Guidance Development Lists

AdvaMed, MITA Call for Tweaks to CDRH’s Proposed FY 2019 Guidance Development Lists

Posted 05 December 2018 | By Ana Mulero 

AdvaMed, MITA Call for Tweaks to CDRH’s Proposed FY 2019 Guidance Development Lists

Industry groups offered feedback on the lists of guidance the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) proposed to develop during this fiscal year.

The comment period on the guidance development lists proposed for medical devices closed earlier this week, with AdvaMed and the Medical Imaging & Technology Alliance (MITA) among those that responded to the October call for feedback. The groups addressed the list of guidances CDRH “fully intends to publish” (A-list) and those the center intends to publish “as resources permits” (B-list).

The feedback builds off the A- and B-lists’ order of priority by sorting the proposed guidance topics into those the groups believe should be of high, medium or low priority for CDRH during FY 2019. It is intended to inform the agency’s understanding of the most and least pressing issues facing industry.

There was consensus among the two industry groups around six of the A-list draft guidances CDRH proposed to finalize in FY 2019 that are of high priority to member companies. These include: MITA and AdvaMed also attached high-priority status to final guidance on recommendations for waiver applications under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) for manufacturers of in vitro diagnostic (IVD) devices. CDRH issued a redraft of these CLIA policies last month in response to industry pushback on the 2017 version.

CDRH issued the revised updates to CLIA waiver recommendations in conjunction with new draft guidance regarding the dual 510(k) and CLIA waiver regulatory pathway. The first A-list draft guidance was completed in October to clarify the required premarket submissions content for medical device cybersecurity.

Out of the seven remaining A-list topics for pending draft guidance, updates to 2005 guidance on the content of premarket submissions for medical device software was considered to be of the highest priority to both industry groups. New draft guidance on “Nonbinding Feedback After Certain FDA Inspections of Device Establishments” is also a high priority for AdvaMed and its member companies.

Both groups called on CDRH to include an additional final and draft guidance topics in the A-list. Final guidance of high-priority for MITA involves medical device labeling requirements. AdvaMed recommended adding draft guidance for manufacturing site inspections under the FDA Reauthorization Act of 2017 and for leveraging artificial intelligence and/or machine learning in medical devices.

AdvaMed also recommended moving four of the five B-list final guidances up to the A-list, including the unique device identifier topics, IVD reagents and instrument families and X-ray imaging devices’ conformance with standards. The group further identified six draft guidances to add to the A-list that are already issued but were left out from the lists, such as 2017 draft guidance on investigational IVDs in oncology trials.


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