por Thomas Dworetzky
, Contributing Reporter | March 11, 2019
But an FDA official said the exemptions are for issues “well-known and well-documented".
Agency spokeswoman Deborah Kotz told KHN by email that there was no public notice or regulations for the “registry exemption” and that “any device manufacturer can request an exemption from its reporting requirements.”
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Another FDA spokeswoman, Alison Hunt, told KHN that the “majority of exemptions” have since been revoked, and now a report is publicly filed and the program allows “the FDA to more efficiently review adverse events … and take action, when warranted, without sacrificing the quality of our review or the information we receive.”
The KHN story came out on March 6 and was shortly followed on March 7 by an FDA announcement
that it was launching new actions aimed at addressing the surgical stapler concerns, and appeared to acknowledge the existence of the non-public reports' potential for problems.
“We are aware that many more device malfunction reports during this time frame (from January 1, 2011 to March 31, 2018) were submitted as Alternative Summary Reports. We are conducting an ongoing analysis of both these reports and of medical device reports received since March 31, 2018. The results of this analysis, when complete, will be available to the public along with the materials for the upcoming advisory committee meeting. These devices are not currently eligible for alternative summary reporting or Voluntary Malfunction Summary Reporting,” the FDA said in its statement, referring to the staplers.
It also stated that, “our analysis, which is ongoing, found that from January 1, 2011 to March 31, 2018, the FDA received over 41,000 individual medical device reports for surgical staplers and staples for internal use, including: 366 deaths, over 9,000 serious injuries, and over 32,000 malfunctions.”
The agency also announced its intention to issue “a draft guidance for public comment in 2019 concerning product labeling information,” and hold an open public meeting of the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee to weigh reclassifying staples as Class II devices, which “would allow the FDA to establish mandatory special controls and require premarket notification (510(k)).”
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