The US Food and Drug Administration (FDA) on Tuesday offered final guidance for companies that will have to conduct performance testing to support claims that their surgical gowns can keep out liquids and submit a 510(k) application within 60 days to the agency to prove those claims.
In 2000, FDA issued a final rule clarifying the difference between gowns worn by health care personnel and surgical apparel worn by operating room personnel during procedures where the gowns need to protect both the patient and the operating room personnel from the transfer of microorganisms, body fluids and particulate material.
“A gown that is not intended for use as a surgical gown is a Class I exempt device that is not subject to premarket notification requirements, and a gown that is intended for use as a ‘surgical gown’ is a Class II device subject to premarket notification,” FDA says.
But as the draft guidance from last June noted, there’s been confusion over the terminology (some standards-setting bodies use the term “isolation gown”) and which companies have to conduct the performance testing needed to support liquid barrier claims.
FDA says that companies wondering if their gowns are Class II devices and whether a 510(k) needs to be submitted should consider whether the gown is labeled as a “surgical gown,” if the company has stated that the gown offers “moderate or high level barrier protection,” and/or has statements that the gown is intended for sterile procedures.
“FDA considers both level-of-protection claims and the terminology used (e.g., isolation, nonsurgical, procedural, operating room) because of such devices’ substantial importance in preventing impairment of human health,” the agency says.
The agency is calling for surgical gown companies to submit 510(k) applications for their Class II gowns within 60 days of the issuance of the final guidance, or by 9 February 2016.
“We continue to believe this timeframe for submission is appropriate since submitters should already have conducted the testing to support their particular liquid barrier claims,” the agency said in its release of the final guidance, noting that some commenters on the draft guidance took issue with the timeframe.
The agency also says it intends to work interactively with manufacturers, as appropriate, during the review process, and if a manufacturer has not received clearance for its device within 180 days of submitting a 510(k), but the submission remains under active review, the manufacturer “should contact FDA to discuss whether the agency intends to continue to defer enforcement under these circumstances.”
In addition to the items identified in FDA’s 1993 Guidance on Premarket Notification [510(k)] Submissions for Surgical Gowns and Surgical Drapes, the agency wants:
- Evidence that the gown complies with the claimed barrier performance criteria of the currently FDA-recognized version of ANSI/AAMI PB70, or equivalent standard
- Performance test data to demonstrate that the gown is an effective barrier in accordance with ANSI/AAMI PB70 barrier performance specifications. For both single use and reusable gowns, barrier performance testing should be completed on the final, finished, pre-shipment gown, at the end of the stated shelf life of the gown. If the gown is intended to be reusable, barrier performance testing should also be performed at the end of the labeled use-life (maximum reprocessing cycles).
- Representative engineering drawing(s), schematics, illustrations and/or figures of the gown that are clear, legible, labeled with the barrier protection levels of the gown, and include dimensions and the location of the critical and non-critical zones.
- Sample labeling that clearly identifies the level of liquid barrier protection per ANSI/AAMI PB70.
- Sample labeling that includes the direction(s) for use and indication(s) for use.
FDA also highlighted that multiple comments on the draft guidance requested revisions of the guidance’s terminology, though FDA says the intent of the guidance was not to change existing terminology and such changes would require additional regulatory action
For the comments received related to specific products, FDA is encouraging submitters to contact the review division directly or submit a pre-submission to address these concerns.
On 21 January, 2016, FDA will hold a webinar for industry to review
the guidance document and answer questions.
Premarket Notification Requirements Concerning Gowns Intended for Use in Health Care Settings