The statutory foundation of medical device regulation is a 3-tiered risk-based classification system. Every medical device is classified according to its specific risks to health, from low to high, and each classification level establishes a set of controls from which FDA chooses to best regulate the individual product. See Table 1. □

Class I: General Controls

This article will explore how this basic regulatory structure applies to menstrual tampons and vaginal pessaries.

To bring its new product to market, the manufacturer (or developer) of a Class II medical device must submit a 510(k) premarket notification to the FDA. The essence of such a notification is the identification of a legally-marketed device for comparison, known as a predicate device, and a showing that the new device is substantially equivalent to the predicate device in terms of safety and effectiveness, with an emphasis on device design and intended use. In making the 510(k) submission, the manufacturer follows the prescribed regulations and FDA guidance, more on that later. If the manufacturer's arguments for substantial equivalence prevail and FDA determines that the new product (in this case a menstrual tampon) is substantially equivalent to the predicate device, then the manufacturer (or product developer) may bring the product to market. However, if FDA finds that the new device design raises new types of questions on safety or effectiveness, or if FDA finds that the indication for use represents a new intended use, then FDA will issue a finding of NOT (emphasis added) substantially equivalent. By statute, a determination of not substantially equivalent places the new device into Class III, and a Premarket Approval Application is required. For a tampon, this latter possibility is highly unlikely.

To help the developer of a new menstrual tampon plan for and compile a 510(k) premarket notification, FDA provides a device-specific guidance (dated 2005) that delineates the specific kinds of information and data needed to support the tampon application (4). FDA also provides substantial general guidance for developing its arguments for substantial equivalence in the preparation of a 510(k) premarket notification (5). The manufacturer should carefully consider and apply the guidance from both documents, as well as follow the 510(k) regulation (6) itself that spells out the basic format and requirements for a 510(k) submission.

Looking first at FDA's 2005 guidance document for tampon 510(k) submissions, a manufacturer sees that FDA expects the following information: □

Description of the Menstrual Tampon, including the tampon design and dimensions, tampon absorbency, and a full accounting of all component materials of the tampon, including additives.

To further help medical device developers, FDA posts information on each 510(k) decision it makes, including the SE determination letter, an indications for use sheet, and—typically—a brief summary of information supporting the 510(k) submission. For regulatory perspective, it can be very useful to review that historical information (13).

In its 2014 510(k) guidance on how to evaluate substantial equivalence, FDA explains how such arguments are made. To help manufacturers with this, the guidance document includes a substantial equivalence logic flowchart to show how the decision-making works (diagram below) (5).

Regarding use of the flowchart in Figure 1, the FDA guidance emphasizes that the “…flowchart is NOT [emphasis added] intended to be used as a ‘stand-alone’ document and should only be considered in conjunction with the accompanying text in this guidance.” The flowchart and accompanying text should include all appropriate references to the context of each critical decision point.

When the 510(k) premarket notification is received, the statute provides 90 days for the agency to complete its review. FDA may break this 90-day review time into parts, putting the document “on hold” to ask certain follow-up questions. The manufacturer should carefully consider the questions and provide full response. FDA contact information is provided, and if anything is unclear, manufacturers are encouraged to connect directly with the reviewer.

Bringing a vaginal pessary to market would follow a regulatory pathway similar to that described above for menstrual tampons. Again, the manufacturer (or developer) must submit a 510(k) premarket notification to the FDA, following the prescribed regulations and guidance. The submission must provide information showing that the new vaginal pessary is substantially equivalent, in terms of safety and effectiveness, to another similar pessary already legally on the market, the so-called predicate device.

While FDA has not produced a device-specific guidance document on vaginal pessaries, many of the same principles used for the tampon apply to the vaginal pessary. The general guidance for developing arguments for substantial equivalence, discussed above, apply here (14). As with the tampons, the manufacturer should carefully consider this guidance and follow the 510(k) regulation (15) itself that spells out the basic format and requirements for a 510(k) submission.

When preparing a 510(k) premarket notification for a new vaginal pessary and considering the types of information needed to support an argument for substantial equivalence, the manufacturer (or developer) must also consider the intended use of the pessary. Unlike the tampon, a vaginal pessary—depending on its design and the manufacturer's intention—may be used to manage urinary incontinence and/or pelvic organ prolapse. Again, depending on design and manufacturer intention, a new pessary might be available over-the-counter or as a prescription-only device. It might require physician evaluation, need for fitting, insertion and removal, or it might be designed so that the user could insert it and remove it herself. The pessary might be intended as single-use disposable device, for a short period of time, or for longer-term use, reusable with instructions for cleaning. When building the argument for substantial equivalence, the manufacturer must consider all of these device features in the context of the 510(k) SE flowchart (Figure 1), especially as it relates to the predicate device, the indication for use and intended use and whether that might trigger the need for clinical data.

Using the tampon 510(k) submission (described above) as a model, a manufacturer should follow a similar path and can expect that FDA will expect the following information for a new pessary: □

Description of the Vaginal Pessary, including the pessary design and dimensions, insertion features, and a full accounting of all component materials, including additives.

It also important to recognize that FDA employs a comprehensive set of postmarket controls to ensure the continued safety and effectiveness of the device in the market and use settings. Perhaps the most important are good manufacturing practices (GMPs), as spelled out in the Quality Systems regulation (21 CFR Part 820). Other relevant controls include annual registration of device manufacturing facilities, listing of devices, labeling, mandatory device reporting (adverse events) and prohibitions against misbranding (false or misleading in any particular) and adulteration (e.g., corrupted or debased by incorporating an impure or spurious substance). While these regulatory controls are critical to the continued safety and effectiveness of menstrual tampons and vaginal pessaries, this article will not go into the details of those controls.

In summary, in the United States, menstrual tampons and vaginal pessaries are medical devices, subject to a set of premarket and postmarket regulations. Practicing clinicians are often the idea-source for innovative improvements of these products. When working with a product development team, these clinicians should be cognizant of the regulatory environment and be prepared to help their teams accordingly. It is hoped that this article will serve as a useful starting point for clinicians embarking on a program contributing to a 510(k) premarket notification for a menstrual tampon or a vaginal pessary. Clinicians new to such programs seeking marketing authorization from FDA would be well advised to work closely with the regulatory specialist on the product development team before beginning on any clinical trials or initiating contact with FDA personnel.