FDA Issues Proposed Rule Amending Classification and Reclassification Regulations for Medical Devices (21 C.F.R. Part 860)

By Allyson B. Mullen –

On March 25, 2014, FDA issued a proposed rule amending the regulations for classification and reclassification to conform to the changes to the Federal Food, Drug, and Cosmetic Act (the Act) made by the Food and Drug Administrative Safety and Innovation Act (FDASIA).  79 Fed. Reg. 16252 (Mar. 25, 2014).  Under Section 513(e)(1)(A)(i) of the Act, FDA may, based on new information, reclassify a device by administrative order (as opposed to the pre-FDASIA requirement of reclassification by regulation) and revoke any related regulation or requirement in effect under a PMA approval order.  FDA may undertake such reclassification on its own initiative or upon request from an interested person.  21 U.S.C. § 360c(e)(1)(A)(i).  The post-FDASIA statutory procedures have made it easier to reclassify medical devices (see our prior post here).  

The proposed rule seeks to implement the statutory changes from FDASIA in the regulations and to bring clarity to the classification and reclassification process for devices.  The changes that FDA proposes making to Part 860 include removing repetitive language from the regulations, using definitions that are consistent with the statute, and clarifying the class III device definition.  By modifying the class III device definition, FDA intends to make it clearer which devices that are currently classified as class III are not suitable for down-classification.

Specifically, FDA has proposed making the following material changes to the 21 C.F.R. Part 860:

• In 21 C.F.R. § 860.3
• Changing the term “life-supporting or life-sustaining device” to “supporting or sustaining human life.”
• Making minor clarifying changes and removing repetitive language from the definitions of class I and class II devices.
• Clarifying the definition of “generic type of device” to address the inter-relationship between a device product code, generic type and classification regulation.
• Removing definitions for “classification questionnaire” and “supplemental data sheet” because FDA has proposed removing the use of these forms.
• Adding definitions of “general controls” and “special controls.”  The definition of general controls is consistent with the definition in Section 513(a)(1)(A) of the Act.  The definition of special controls identifying such controls as necessary to provide a reasonable assurance of safety and effectiveness for a class II device.
• Changing the defined term “implant” to “implantable device.”  This change has been incorporated throughout Part 860.
• Adding a definition of a “special controls guideline” as a means for providing reasonable assurance of safety and effectiveness pursuant to Section 513(a) of the Act.
• In 21 C.F.R. § 860.3, substantially rewriting the definition of class III.  The proposed rule defines a class III device as one that is classified as such under section 513(f)(1) or 520(l)(1) of the Act, or a device for which there is insufficient information to determine if general or special controls are sufficient to provide a reasonable assurance of safety and effectiveness and the device (1) is intended for use in supporting or sustaining life; (2) is intended for “a use that is of substantial importance in preventing impairment of human health;” or (3) presents a potential unreasonable risk of illness or injury.  The proposed definition seeks to clarify when the Commissioner can find that there is insufficient information to determine if general or special controls are sufficient to provide a reasonable assurance of safety and effectiveness by listing five examples:
• Devices that have a favorable risk-benefit profile, but present “significant risks that cannot be adequately controlled through general or special controls.”
• Devices that have an unknown or unfavorable risk-benefit profile.
• Devices that have a favorable risk-benefit profile but require more stringent controls, including a full review of manufacturing information.
• Devices that require premarket review of any changes that may affect safety or effectiveness of the device.
• Combination products with a device primary mode of action, which include a drug or biologic constituent part that require a finding of safety and effectiveness, and such a finding has not been made.
• In 21 C.F.R. § 860.7, updating the class II classification or reclassification requirements for safety and effectiveness.  The proposed changes include establishment of special controls for class II devices, thereby replacing the term “performance standard” because special controls include performance standards.  This change has been adopted through the remainder of Part 860 as well.
• In 21 C.F.R. §§ 860.84 and 860.123, removing the requirement to utilize classification questionnaire and supplemental data sheet as part of the classification process.  FDA now requests that practitioners focus on providing information regarding “review of available valid scientific evidence, appropriate regulatory controls give the risks presented by the device, and regulatory standards to understand whether general controls are sufficient to provide [reasonable assurance of safety and effectiveness] or whether general controls and special controls are sufficient to provide [reasonable assurance of safety and effectiveness].”
• Adding new 21 C.F.R. § 860.90 and amending 21 C.F.R. § 860.125 to explain how and when FDA will consult with panels regarding classification of preamendment devices.
• In 21 C.F.R. § 860.93, adding a provision requiring that any panel recommendation for classification or reclassification into class II for any implantable device or any device intended for use in sustaining or supporting human life must describe the special controls necessary for providing reasonable assurance of safety and effectiveness. 
• In 21 C.F.R. § 860.120, clarifying that a reclassification can pertain to all of the devices within a classification or only one generic type, and that the Commissioner can reclassify class I, II or III devices into any of the other classes and under what conditions a reclassification may be initiated.
• In 21 C.F.R. § 860.130, amending the language to reflect the new reclassification procedures from FDASIA and requiring that a proposed reclassification order must include “(1) A substantive summary of valid scientific evidence, including the public health benefits and risks of the device; (2) when reclassifying from class II to class III, an explanation that general and special controls are insufficient to reasonably assure safety and effectiveness; and (3) when reclassifying from class III to class II an explanation that general and special controls are sufficient to reasonably assure safety and effectiveness.”
• In 21 C.F.R. § 860.132, making the process to initiate reclassification of a device after FDA has initiated the establishment of a performance standard or requirement for a PMA consistent with FDASIA.
• In 21 C.F.R. § 860.133, revising the procedures for requiring the filing of a PMA for a class III preamendment device to be consistent with FDASIA, including issuance of the final rule in the Federal Register and holding a classification panel meeting.  A proposed order must include the same information discussed above in 21 C.F.R. § 860.130.  Given the dwindling number of class III preamendment devices, this will affect only a few devices.
• In 21 C.F.R. § 860.134, clarifying the process for reclassifying postamendment devices and including a reference to the de novo classification process.  Also, the proposed rule adds the process for reclassification of a postamendment device when such reclassification is initiated by FDA.
• In 21 C.F.R. § 860.136, revising the procedures for reclassification of a transitional device when initiated by FDA or by the manufacturer or importer. 

The most interesting of the proposed changes is the new definition of class III.  The portion of the definition defining a class III device is relatively unchanged, although we find the proposed definition easier to read.  The addition of the five categories of devices for which there is insufficient information to determine if general or special controls are sufficient to provide a reasonable assurance of safety and effectiveness are likely to elicit the most comments from industry.  While the amendments to the reclassification procedures in FDASIA have made it easier for FDA to reclassify devices, the proposed substantive changes to the class III definition shows that FDA wants industry to know which devices the Agency believes are class III.  This change not only affects requests for reclassification of current class III devices to class I or II, but will also likely impact new devices seeking classification through the de novo pathway.  Thus, the change to the class III definition could result in a great number of new devices requiring approval of a PMA rather than clearance through a de novo petition. 

Comments to the proposed rule may be submitted through now and June 23, 2014.