In 1988, FDA issued a final rule defining “surgical apparel” under Title 21, Section 878.4040 of the Code of Federal Regulations (CFR). Under this regulation, surgical gowns and masks were classified as Class II medical devices and, as such, made subject to premarket review under section 510(k) of the Federal Food, Drug, and Cosmetic Act.
Surgical apparel other than gowns and masks was classified as a Class I medical device under the regulation and is also subject to 510(k) premarket review requirements.
Since the 1988 rule was put in place, FDA notes that a number of terms have evolved to refer to gowns intended for use in healthcare settings including—but not limited to—surgical gowns, isolation gowns, surgical isolation gowns, nonsurgical gowns, cover gowns, comfort gowns, procedural gowns, and operating room gowns.
Moreover, in 2004, FDA recognized the joint consensus standard PB70:2003, “Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities,” developed by the American National Standards Institute and the Association of the Advancement of Medical Instrumentation (ANSI/AAMI). This standard utilized new terminology for barrier performance of gowns and assessed barrier protection levels by specifying test methods and performance results necessary to verify and validate the newly-defined levels of barrier protection.
According to FDA, however, definitions and terminology used in this standard are inconsistent with the agency’s historical definitions and these inconsistencies have stoked confusion in the marketplace. This is another reason FDA cites for developing the guidance document.
To address these issues, the guidance notes that gowns are considered Class I devices, and exempt from premarket notification, if all the following factors exist:
- The gown is labeled as something other than a surgical gown (e.g., isolation gown);
- It is not described in its labeling as a surgical gown; and
- If it has statements relating to barrier protection claims, such statements only cite minimal or low barrier claims to show the gown is intended for nonsurgical use.
- Gowns are considered Class II medical devices, and are subject to premarket notification, if:
- It is labeled as such; (e.g., “surgical gown” or “surgical isolation gown”);
- It is described as such in its labeling; (e.g., this gown is suitable as a surgical gown”);
- Has statements relating to moderate or high level barrier protection (e.g. ANSI/AAMI Level 3 or 4 barrier protection claims); and/or
- Has statements that it is intended for use during sterile procedures (e.g. distributed in sterile package).
For gowns that are considered to be a Class II device under 21 CFR 878.4040(b)(1) and subject to premarket notification, manufacturers should include the following in their 510(k) submission:
- Evidence that the gown complies with the claimed barrier performance criteria of the FDA-recognized version of ANSI/AAMI PB70, or equivalent standard. ANSI/AAMI PB70 establishes physical performance and documentation requirements for gowns and their materials;
- Performance test data to demonstrate that the gown is an effective barrier in accordance with ANSI/AAMI PB70 barrier performance specifications. Barrier performance testing should be completed on the final, finished, pre-shipment gown, or at the end of the stated shelf life of the gown, as applicable, if the gown is reusable;
- 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; and
- Sample labeling that includes the direction(s) for use and indication(s) for use.
FDA called for public comment on the draft version of this guidance document earlier in the year and, according to the agency, multiple comments requested revisions to terminology used in the guidance. FDA dismissed these concerns, however, by noting that “the intent of the guidance was not to change existing terminology as used by the Agency, but rather to clarify and describe the premarket regulatory requirements concerning gowns intended for use in healthcare settings. While the focus of any future actions on this topic may include discussion on changing terminology, such changes would require additional regulatory action and are outside the scope of this guidance.”
Several comments also addressed the agency’s expectation that a 510(k) would be submitted within 60 days if gowns are not currently in compliance with expectations outlined in the guidance. The Agency dismissed these concerns as well, noting, “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.”
With regard to comments the agency received on specific products, FDA says it’s inappropriate to address such product-specific concerns in a guidance document, and encourages submitters to contact the Agency’s Review Division directly or submit pre-submission materials instead.
FDA’s January 21 webinar is intended as an opportunity for the industry to review the guidance document and ask questions (which FDA welcomes). No registration is required.
The webinar will run from 1-2 p.m., Eastern Time, and FDA recommends that participants dial in at least 15 minutes early. The call in number is 888-566-7703 and the passcode is 5643932. International callers should dial 603-395-0068, but use the same passcode.
A transcript, audio recording, and slides from the webinar will also be available after the event at www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm411063.htm
For questions or additional information, please contact the Division of Industry and Consumer Education (DICE) in FDA’s Center for Devices and Radiological Health (CDRH) at 1.800.638.2014 or via email addressed to firstname.lastname@example.org