First Fruits of FDASIA’s New Device Reclassification Procedure

By Jeffrey K. Shapiro –

We are seeing the first fruits of a new device reclassification procedure added last summer to the Federal Food, Drug, and Cosmetic Act (“FDCA”).  The new procedure modifies Section 513(e) of the FDCA to make it easier for FDA to reclassify devices (see Food and Drug Administration Safety and Innovation Act (“FDASIA”), Pub. L. No. 112-144, § 608(a); HP&M FDASIA Summary and Analysis at page 37).

As before, based on new information about a device, FDA may on its own initiative or after petition by an interested person reclassify the device and revoke any related regulation or requirement in effect under a PMA approval order. 

The difference is that previously FDA was required to issue a reclassification regulation, while now FDA can accomplish the same thing by administrative order.  The order is to be issued “following publication of a proposed reclassification order in the Federal Register, a meeting of a device classification panel … and consideration of comments to a public docket.”  FDASIA, § 608(a).

Why is issuing a proposed order for notice and comment less burdensome to FDA than issuing a proposed rule for notice and comment?  It may be simply that an agency order does not have to undergo the same level of internal Executive branch scrutiny prior to issuance as does an agency regulation.  Notably, the latest proposed orders lack the “analysis of impacts” section that can be found in FDA’s proposed rules.

In any event, the agency has issued four proposed orders to reclassify the following preamendment devices:

• Temporary mandibular condyle prosthesis, 78 Fed. Reg. 9010 (Feb. 7, 2013);
• Blade form endosseous dental implant, 78 Fed. Reg. 2647 (Jan. 14, 2013);
• External cardiac compressor, 78 Fed. Reg. 1163 (Jan. 8, 2013); and
• Membrane lung devices for pulmonary support, 78 Fed. Reg. 1158 (Jan. 8, 2013).

The fifth proposed order is a call for PMAs for metal on metal hip prostheses (cemented and uncemented).  78 Fed. Reg, 4094 (Jan. 18, 2013). 

These six device types are among the 25 preamendment Class III device types not yet subject to a final regulation reclassifying them to Class I or II or calling for PMA submissions.  FDA has been repeatedly urged to complete this process, which began about 37 years ago, in 1976. 

All 25 device types were subject to FDA’s April 9, 2009 order requiring manufacturers to provide information on safety and effectiveness (see our previous post here).  The information submitted in response to this order is the “new information” that FDA is relying upon to invoke Section 513(e). 

Interestingly, in all the proposed orders, FDA relied on panel meetings that have already taken place, even though the statute seems to contemplate a panel meeting after the proposed order is issued.

Hopefully, the streamlined Section 513(e) will allow FDA to promptly finish the classification process for preamendment devices.  Once that is done, FDA should use the amended Section 513(e) to more swiftly reclassify devices.  The greater use of reclassification will make FDA’s regulatory process more nimble and able to calibrate regulatory burden more appropriately on the basis of risk, which is what the statutory scheme requires.