Medical device industry group AdvaMed and the Association for the Advancement of Medical Instrumentation (AAMI) are seeking additional information from the US Food and Drug Administration (FDA) on draft guidance related to the recognition and withdrawal of voluntary consensus standards.
The 8-page draft
from September describes the procedures that FDA follows and the actions the agency may take during its review and evaluation of requests for standards recognition or the withdrawal of recognition.
While noting that the draft contains helpful language regarding the rationale that FDA would provide, per the statute, if it decides to not recognize the standard, AdvaMed calls on the agency to provide “a similar explanation” to elucidate why FDA has decided not to recognize part of a standard.
“Such rationales would support differences that may occur within submission documents used for multiple geographies. Manufacturers need to clearly understand the rationales/reasons for why some sections are or are not recognized, to be able to apply to internal documentation that may be used both within and outside of the United States,” AdvaMed said.
The industry group also recommends that FDA provide explanations for any transition period shorter than 36 months, as such insufficiently lengthy transition periods can cause a manufacturer substantial difficulties in addressing what is not a significant issue or will not have an impact on a patient.
“The integration of new expectations into product design, verification, validation, labeling and updated regulatory documents can be a time-consuming and resource-intensive effort,” AdvaMed said.
AdvaMed also encourages FDA to add language indicating that it will consider harmonization in recognition and withdrawal decisions, particularly language similar to the statute, which directs FDA, in updating standards recognition guidance, to take “into account the experience with and reliance on a standard by foreign regulatory authorities and the device industry, and whether recognition of a standard will promote harmonization among regulatory authorities in the regulation of devices.”
On the topic of harmonization, AdvaMed further calls on FDA to align the end of transition periods with other global regulators.
“To the extent possible, the end date of a transition period should align with the date of withdrawal established for equivalent European, Canadian or other international adoptions of the same standard. As discussed above, harmonizing standards recognition internationally is a benefit to both regulators and industry. International harmonization of transition periods will result in a least burdensome application of standards for both FDA and manufacturers,” AdvaMed said.
AAMI, meanwhile, applauded FDA for clarifying the process for use of national and international voluntary consensus standards and offered one recommendation focused on the timing for transition into the use of a new or revised standard.
“Within the draft guidance there is language concerning the Supplementary Information Sheet (SIS). The SIS may contain information concerning the transition period between the new and old versions of a standard. AAMI, and its constituent members, feel that the process could be improved by the following addition. ‘The SIS shall include an explanation for any transition periods of less than 36 months from the standard publish date.’ AAMI believes that shorter transition periods would be justified when the revision to a standard was driven by a new threat to public safety. Adoption of a default three-year transition period would be more in line with the least burdensome approach adopted by the FDA.”