The U.S. Food and Drug Administration (FDA) has jurisdiction over medical devices offered for sale in the U.S. Certain healthcare products made from nonwovens like surgical drapes and gowns, wound care materials, adult diapers, tampons and menstrual pads are classified as medical devicesand, as such, cannot be brought to market or modified until they have gone through an agency process known as 510(k) review.
The 510(k) review process is well known to nonwovens industry manufacturers in healthcare and hygiene markets and has been an aspect of product development and stewardship for years. But for some industry members, it appears that things are going to be much easier when it comes to bringing new products to market or modifying products that are already on the market.
510(k) in a Nutshell
In what has been standard practice for decades, medical device manufacturers have to register with FDA and notify the agency at least 90 days before bringing a new product to market. This is part of Premarket Notification–also called PMN–under the law and outlines the 510(k) process. A stated intent of the 510(k) review is to give FDA time to determine if the new or modified product is “equivalent” to a device that’s already on the market.
As FDA explains the process, “…medical device manufacturers are required to submit a premarket notification if they intend to introduce a device to commercial distribution for the first time or reintroduce a device that will be significantly changed or modified to the extent that its safety or effectiveness could be affected. Such change or modification could relate to the design, material, chemical composition, energy source, manufacturing process or intended use.”
If FDA determines that a new or modified product is equivalent to something already on the market, the manufacturer can start selling it virtually immediately. If, on the other hand, FDA determines that the proposed device is something truly different from everything else that’s already out there, then a different, far more complex and costly, approval process is required.
2015 Guidance
In mid-August, FDA issued a guidance document entitled “Intent to Exempt Certain Unclassified, Class II, and Class I Reserved Medical Devices from Premarket Notification Requirements: Guidance for Industry and Food and Drug Administration Staff.” In this guidance, the Agency notes that:
“This guidance describes FDA’s intent to exempt certain unclassified medical devices (that FDA intends to classify into class I or II), certain class II medical devices, and certain class I medical devices (that no longer meet the “reserved” criteria in section 510(l) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 360(l)) from premarket notification requirements. FDA believes the devices and product codes being added to this guidance document are sufficiently well understood and do not require 510(k) notification to assure their safety and effectiveness (Federal Register, August, 14, 2015, page 48868, emphasis added).
As part of the reauthorization process for the Medical Device User Fee Amendments of 2012 which, in turn, was part of the Food and Drug Administration Safety and Innovation Act (FDASIA), FDA committed to identifying “low-risk” medical devices that could be exempted from 510(k) requirements because the devices are already well understood and pose little known risk.
FDA guidance documents don’t establish legally-enforceable responsibilities. They are, instead, intended to describe the Agency’s thinking on a topic at any given time and, therefore, should be viewed only as recommendations. That said, FDA notes that—until publication of a final rule or some other order contradicting the guidance—the agency “does not intend to enforce compliance with 510(k) requirements for these devices, nor does the Agency expect manufacturers to submit 510(k)s for these devices during this time period.”
Impacted Nonwovens
With regard to nonwovens, FDA has identified the following devices classified under 21 CFR 878.4370–surgical drape and surgical drape accessories – and is exempting them:
ERY - Drape, Surgical, Ent
EYX - Drape, Pure Latex Sheet, With Self-retaining Finger Cot
EYY - Drape, Urological, Disposable
FNW - Pad, Kelly
HMT - Drape, Patient, Ophthalmic
HMW - Drape, Microscope, Ophthalmic
KGW - Ring (Wound Protector), Drape Retention, Internal
KKX - Drape, Surgical. This intention does not apply to devices including an antimicrobial agent.
Interestingly, FDA appears to have adopted a change requested by 3M for the last item on this list (KKX Drapes that include an antimicrobial agent). In comments filed late last year 3M noted that:
Urgent efforts to combat antimicrobial resistance have begun on a large scale. These efforts include actions by government, industry and healthcare providers and depend on limiting the overuse of antimicrobial agents. The proposed exemption runs contrary to these efforts. By exempting surgical drapes with antimicrobials from the 510(k) preclearance pathway, manufacturers will no longer be required to provide data to FDA for review. Without this data, there is no assurance that the risk of antimicrobial resistance in these products will be outweighed by the potential benefits.
FDA is exempting two products classified under 21 CFR 884.5435–i.e., unscented menstrual pad–from 510(k) requirements— NUQ - Pad, Menstrual, Reusable
and NUR - Pad, Interlabial.
Among other products listed in the guidance, it’s noteworthy that FDA has decided to exempt devices coded “HHE - cup, menstrual,” from premarket approval requirements. Menstrual cups and reusable pads are, of course, direct competitors to single-use feminine hygiene products.
In public comments filed in response to a previous version of this guidance, several applauded FDA action with regard to reusable pads and the menstrual cup because these items are not intended to go into the body, and their risks – such as they are – are well understood. But, per 3M’s concerns, the other side of the coin is that material can now likely be added to reusable pads and menstrual cups can be altered significantly without FDA’s knowledge, consent, or scientific understanding.
Copies of the guidance document and public comments can be found at regulations.gov by searching under FDA-2014-D-0967; and questions about the guidance should be directed to Angela Krueger at 301.796.6380 or e-mail angela.krueger@fda.hhs.gov.