Device Companies Offer Perspective on CDRH Guidance Priorities

Regulatory NewsRegulatory News | 13 February 2018 |  By 

Device companies Johnson & Johnson, Abbott and industry group AdvaMed offered their opinions on which guidance documents they believe the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) should prioritize this year, according to comments posted Monday to the docket.

The comments follow CDRH’s offering up a list of prioritized draft and final medical device guidance documents (known as the "A" list) and others CDRH intends to publish (known as the "B" list).

Of the final guidance documents on the "A" list, AdvaMed said the ones that are of the highest priority to its member device companies are related to the appropriate use of voluntary consensus standards in premarket submissions (draft issued in 2014 and also mentioned by Abbott and the Medical Imaging & Technology Alliance as a priority), one on next generation sequencing-based in vitro diagnostics (IVDs) and one on the use of public human genetic variant databases to support clinical validity for genetic- and genomic-based IVDs.

Highest priority draft guidance on the "A" list, according to AdvaMed, include those related to the 510(k) third party review program, expansion of the abbreviated 510(k) program with demonstrations of substantial equivalence (also mentioned as a priority for Abbott), the application of acceptable uncertainty to support marketing authorization decisions, and the validation of automated process equipment software (also noted by Abbott).

AdvaMed also made recommendations on FDA finalizing several of the draft guidances issued within the last year, moving certain guidance documents from the "A" to the "B" list, and which other guidances should be updated and revised.

J&J, meanwhile, requested that FDA include "Unique Device Identification System: Defining the Labeler Guidance for Industry and Food and Drug Administration Staff" as a draft guidance in the priorities list.

"We believe this guidance should be added to the Priority ‘A’ Draft-list to ensure that the term of UDI Labeler is created and defined to ensure the proper party is submitting Global Unique Device Identification Database (GUDID) data as this supports FDA focus on GUDID data quality," J&J said, also requesting the finalization of the draft guidance on UDI form and content from July 2016 and its inclusion in the "A" list.

Another request for the "A" list of draft guidance from J&J is one on patient-specific orthopedic implants created from patient imaging scans with the use of segmentation and planning software.

In addition, Abbott said it prioritized draft guidance on export certificates and considerations for multifunctional devices.



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