CMS Considers National Coverage Policy for Thermal Disc Therapies.  The Centers for Medicare and Medicare Services (“CMS”) is considering the adoption of a national coverage policy for procedures that apply heat directly to spinal discs to treat pain in the lower back.  Procedures such as Intradiscal electrothermal annuloplasty (“IDET”), in which a catheter and flexible electrode are used to apply heat directly to the spinal discs causing lower back pain, are to be considered in this internally generated review.  CMS’s decision could affect devices such as Valleylab’s discTrode, Baylis Medical’s TransDiscal, and Smith & Nephew’s SpineCath.  Although CMS has not articulated the reasons behind its decision to review coverage of these devices, some have suggested that the agency is responding to concerns about the evidence supporting thermal disc therapies.  Public comments are due to the agency by February 14, 2008; CMS will propose a decision by July 15, 2008.  Additional information is available at www.thegraysheet.com (paid subscription service).

New Portal for FDA Dockets.  Public comments can no longer be submitted to the U.S. Food and Drug Administration (“FDA”) through the agency’s website.  Effective January 15, 2008, those wishing to submit public comments to FDA must do so through the Federal eRulemaking Portal at www.Rgulations.gov.  All dockets that were previously managed by FDA’s system will be moved to the federal system in the coming months.  Additional information available at www.thegraysheet.com (paid subscription service).

Approval Required for Most Labeling Changes.  FDA published a new proposed rule on labeling changes for drugs, biologics, and medical devices in the January 16, 2008, Federal Register.  The draft rule reiterates the agency’s position that manufacturers may only amend labeling for a drug or device if they have “newly acquired” safety information about the product.  The rule would clarify that even the strengthening of a contraindication or warning is permitted without prior FDA approval only when “there is sufficient evidence of a casual association with the [product].”  This draft rule seeks to codify the agency’s longstanding position on when a labeling change may be made prior to FDA approval.  The draft rule strengthens the PMA preemption defense that many drug and device manufacturers assert in products’ liability tort actions.  Additional information is available at www.thegraysheet.com (paid subscription service). 

Priorities for 2008 Shaped by FDA User Fee Commitments.  In response to the FDA Amendments Act of 2007 (“FDAAA”), and to the many commitment letters issued by the agency, FDA will pay special attention to in vitro diagnostics (“IVD”), which make up the device group that is the target of the greatest number of commitments.  FDA has pledged to issue or revise guidance documents for six specific IVD topics and to assess numerous reforms to the process of granting waivers for tests under the 1988 Clinical Laboratory Improvement Amendments (“CLIA”).  The agency will consider whether certain “low-risk” IVDs can be made exempt from 510(k) requirements and whether its pre-investigational device exemption (“pre-IDE”) meeting process can be improved for these devices.  In addition, the agency will look into streamlining and combining the 510(k)-review and CLIA-waiver review process for IVDs.  Additional information is available at www.thegraysheet.com (paid subscription service).