FDA recently released an updated guidance document to clarify regulatory requirements for gowns. This new guidance impacts manufacturers that currently sell gowns as well as manufacturers that intend to market gowns in the future. The guidance clarifies what types of gowns fall under the class of medical devices that require a 510k prior to being introduced into the market (Class II). Table 1 describes which class of medical device (Class I or Class II) a gown would belong to based on terminology used to describe the gowns on the market claims:
Table 1: Terms used to describe and market gowns by medical device classification
Isolation gowns are generally Class I devices as they are intended to be used in general patient care situations where the exposure risk is low and the barrier performance is low or minimal. Isolation gowns can become Class II devices if additional claims are made that describe the gown as providing moderate or high barrier protection.
Gowns previously listed as Class I that now qualify as Class II must go through the 510(k) submission process and provide data to substantiate their claims. To determine which class a gown would belong, it is recommended to follow the 1993 and 2015 Guidance Documents for Surgical Gowns. These documents can be found at: http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm081305.pdf and http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM452804.pdf.
The 510(k) should include barrier performance plus physical and safety testing with the recommendations shown in Table 2 and Table 3:
Table 2: Performance testing requirements as outlined in ANSI/AMMI PB70 for the classification of barrier performance of surgical gowns, isolation gowns, other protective apparel, surgical drapes, and drape accessories.
Performance testing shall comply with the sampling requirements outlined in PB70. A statistical sampling plan is necessary to justify test quantity and test locations. Typically, 32 test samples from each test location are chosen. All critical and non-critical zones, including the back of the gown as outlined in PB70, must be tested. The back of the gown can also be classified as non-protective which warrants no testing. The labeling of the gown must identify the level of liquid barrier protection per ANSI/AMMI PB70.
Table 3 FDA recommended physical and safety testing to ensure gown performance.
The deadlines for manufacturers proposing to market, or are currently marketing, Class II gowns under the new guidance are as follows:
Feb. 2, 2016: Submit a 510(k) request for the gown to FDA
Feb. 17, 2016: Obtain acceptance of the 510(k) by FDA
Jun, 1, 2016: Obtain 510(k) Clearance for the gown