FDA Imposes Stricter Regulatory Controls on Surgical Staplers for Internal Use
FDA is imposing stricter regulatory controls on surgical staplers for internal use, reclassifying the medical devices from class I (general controls) to the higher-risk category class II (special controls), it said in a final order released Oct. 7. The change means surgical staplers for internal use will be subject to 510(k) premarket review requirements and other conditions prior to marketing the devices. The new classification does not affect surgical staplers for external use, which are being given a new, separate classification to distinguish them from those for internal use.
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The change is effective Oct. 8. Surgical staplers for internal use that have not been offered for sale prior to that date or those that have been but are required to submit a new 510(k) must obtain 510(k) clearance starting Oct. 8 before they are marketed or face enforcement action. For surgical staplers for internal use that have been offered for sale prior to Oct. 8 and do not already have 510(k) clearance, FDA will not enforce compliance with the 510(k) requirement or special controls until 180 days after the Oct. 8 effective date of the final order, the agency said.
FDA also on Oct. 7 released a new guidance document on the labeling of surgical staplers and staples for internal use. “These labeling recommendations are being issued because malfunctions and misuse associated with these devices have resulted in serious adverse events, including deaths,” FDA said. The guidance will help “manufacturers develop labeling with information about specific risks, limitations, and directions for use of the device.”