515 Program Initiative

The 515 Program Initiative
(aka reclassification of preAmendments Class III 510(k)s)

Background

FDA regulates medical devices and categorizes them into one of three classes (I, II or III) based on their level of risk. Class I and II devices are generally considered to be lower risk and require FDA clearance of an application referred to as a premarket notification (or 510(k)) in order for the device to be permitted to be sold in the United States. Class III devices, which tend to be higher risk and first-of-a-kind devices, require FDA approval in the form of a premarket approval (PMA) application.

When FDA’s medical device regulation program began in the late 1970s, FDA regulated over 100 Class III device types through the 510(k) program. The intent was that FDA’s regulation would be temporary and that over time, FDA would decide to reclassify those device types (or regulations) into Class I or II, or to sustain the classification in Class III and call for PMA applications.

The process of reclassification is described in FDA’s regulations in Section 515 of the Federal Food, Drug and Cosmetic Act. Over the years, FDA has made progress in this original list; however, as of 2009, 26 medical device regulations remained in this transitional state awaiting final classification. An example of one of the 26 device types is pacemaker programmers, classified under 21 CFR 870.3700, and with product code KRG.

Accordingly, in late 2009, FDA kicked off the 515 Program Initiative to facilitate the final adjudication of these remaining Class III device types.

515 Process Steps

In simple terms, FDA follows these five steps in the 515 Program initiative for each medical device type:

• collect existing scientific information in the public domain and/or from scientific experts in the medical community;
• assess the risks versus benefits, as well as the clarity of knowledge of the medical device type subject to the reclassification;
• issue a proposed rule (proposed classification) of the device type into Class I, II, or III;
• receive and review comments submitted by the public;
• issue a final rule (final classification) on the device type to Class I, II, or III.

A more detailed discussion of these steps follows here:

Step 1 - Collect Existing Information

The first step in the process consists of FDA seeking and obtaining scientific information that exists in the public domain. The official method through which this is done is with FDA’s publishing of a Federal Register (FR) Notice that announces a 515(i), which calls for the public to submit any known relevant information on the medical device type under consideration. In response, anyone can provide information to the Public Docket in response to this FR notice. FDA will then review the information posted to the Public Docket and consider this information in its analysis. Although FDA can choose whether or not it will solicit this information, FDA issued a 515(i) for all 26 pending 26 medical device types.

Additionally, FDA may choose to solicit information through other means, most notably through the holding of a public FDA Advisory Committee (or Panel) Meeting (see this link for more information regarding the Advisory Committee program: http://www.fda.gov/AdvisoryCommittees/default.htm). In an advisory panel meeting, FDA convenes a meeting that features a panel of scientific experts (typically physicians who are experts in the particular subject matter) that discusses the scientific evidence on the safety and effectiveness of the medical device program type. In addition, the Public also has an opportunity to present information at this meeting. The holding of the advisory panel meeting is also optional and would be most likely chosen by FDA in only a few cases involving the most complex cases where public discussion of the medical device program would assist the Agency in its decision.

In cases where FDA will call for a 515(i) to solicit information to the Docket or will hold an advisory panel meeting, FDA will issue an Federal Register notice announcing this intent.

Step 2 - Assess the Risks and Benefits

In the second step, FDA conducts its expert scientific analysis of the information regarding the safety and effectiveness of the medical device type. In this analysis, FDA will form an expert team (usually consisting of an engineer, physician, life scientist and/or other specialists) that will evaluate the scientific merits of reclassification of the device type to Class I or II, or to sustain the classification into Class III. The bases for each category are described below:

• Class I: In order for FDA to reclassify a device type into Class I, FDA needs to determine that the program category is of very low risk. Because most Class I devices are also exempt from 510(k) submission, FDA would also need to determine that future devices classified into this device category would not require 510(k) clearance before they could be marketed in the United States.
• Class II: In order for FDA to reclassify a device type into Class II, FDA needs to be able to do several things: (1) determine that the program category is of moderate risk; and (2) develop “special controls” which characterize the testing and documentation that would be required for all future 510(k) applications.
   
  The aspect of developing special controls can be quite complicated, as it involves the ability to fully understand and characterize the device type sufficient to very clearly describe the device characteristics/specifications, specialized labeling, and testing (preclinical, animal, clinical, and/or human factors) that would be required. The special controls would either be described directly in the regulation or in a Special Controls Guidance Document (SCGD) that outlines this information.
• Class III: FDA can choose to keep a device type classified in Class III. In this case, FDA would determine that the program area is of high risk and/or that the knowledge of the program area is insufficient for special controls to be developed. In this case, sponsors who have previously received 510(k) clearance for their medical devices will need to submit PMA applications in order to continue to market their devices (with a grace period to permit possible transition to obtaining PMA approval).

Step 3 - Propose Classification

The third step consists of FDA issuing a Federal Register Notice which proposes the regulation of the device type into Class I, II, or III (also referred as the proposed rule). In the case where FDA proposes a Class II designation with a special controls guidance document (SCGD), FDA will publish the SCGD in draft.

The Public has an opportunity to provide comment in response to FDA’s issuance of the proposed rule. The comments may be related to anything regarding the proposed classification, for example, the category in which the device type is proposed to be classified, the specific characteristics of the special controls, etc.

Step 4 - Receive and Review Comments

The fourth step consists of FDA receiving and reviewing any comments made in response to the issuance of the proposed rule. FDA will consider all of the comments and may choose to make any changes to the classification (and/or special controls as applicable for Class II devices) based on its consideration of the comments.

Step 5 - Render Final Decision

The fifth and final step consists of FDA issuing its decision of the final classification (or final rule) of the medical device type in the Federal Register. If a draft SCGD was previously prepared, then FDA would also publish a final special control guidance document.

It should be noted that while this fifth step is considered to be the final decision of the 515 Program Initiative, the device categorization is not necessarily permanent. In the future, as with any other device type, FDA may subsequently choose to change the classification of a medical device type area to any other class.