A Medical Device Daily

Bone sonometers are hardly the most exciting device reviewed by FDA these days, but makers of these devices might think the latest news about them from FDA is exciting.

The agency released a July 17 guidance for the reclassification of bone sonometers from class III devices to class II devices that gives sponsors some idea of what to expect in any 510(k) applications. Class II devices require "special controls," but these controls are a lot less work than a PMA. And while clinical data may be needed in a few instances, most sponsors should be able to get to market without clinical trials.

FDA recommends that anyone filing a 510(k) for such a device "include performance specifications," but also describe "how this special controls guidance document was used during device development and testing."

Among the health risks FDA wants to see data for are electrical hazards, electromagnetic interference, tissue damage (due to acoustic intensity) and patient mismanagement.

The guidance states that in many cases, "clinical studies will not be needed," but exceptions include instances in which a device's labeled indications are "dissimilar from legally marketed devices of the same type," but also when a design is "dissimilar from legally marketed designs." Any novel technology embedded in a sonometer may also trigger a clinical data requirement.

A sponsor will have to obtain an investigational device exemption for any such study, but the study may qualify as a non-significant risk study, in which case the institutional review board that oversees the study acts as a proxy for FDA. The guidance also refers to "major differences ... in the record keeping and reporting requirements," but goes into no detail.

Should a sponsor have to undertake clinical studies, FDA recommends that the exclusion criteria should include anyone taking a number of drugs within a time period specified by the sponsor. This list includes bisphosphonates (such as alendronate, aka, Fosamax), calcitonin and therapeutic doses of vitamin D. Also, any patients who have been diagnosed with hyperparathyroidism or hypoparathyroidism in the previous five years should be excluded.

Senate eyes $5.2B more for NIH this year

FDA may have won House approval for a pay raise of almost $300 million recently (Medical Device Daily, June 27, 2008), but don't tell FDAers about a proposal to boost spending at the National Institutes of Health by more than $5 billion in the current federal fiscal cycle.

The chairman and ranking member of a Senate subcommittee announced last Wednesday their intent to provide an emergency bolus of $5.2 billion for FY08 NIH funding, which at present stands at almost $29.4 billion.

The proposal, offered by Tom Harkin (D-Iowa) and Arlen Specter (R-Pennsylvania), chairman and ranking member, respectively, of the Labor-HHS-Education Appropriations Subcommittee (Senate Budget Committee), would increase funding of the National Cancer Institute by $1.2 billion, and the remaining $4 billion would be divided between the other institutes at NIH.

Specter recently finished his chemotherapy regime for a recurrent case of Hodgkin's disease, which initially flared up in 2005. In a recent hearing on the NIH budget, Specter is quoted as having said "funding for NIH is grossly insufficient and Congress must do something about this scandalous situation."

As for fiscal 2009, the Senate is working out a plan to add almost $900 million to the White House's proposed NIH budget of $29.2 billion described as about $150 million less than the 2008 appropriation. Critics of the budget proposed by the White House decry the flat budget for NIH, but NIH's budget has approximately doubled since 1999, when the agency was funded to the tune of roughly $15 billion.

Thermal intradiscal coverage fails

Damage to the outer portion of spinal discs can create misery for the patient, but CMS has proposed not to cover any of a series of procedures known as thermal intradiscal procedures (TIPs) due to lack of compelling evidence that such procedures are reasonable and necessary to treat the associated lower back pain.

According to the July 16 statement by the Centers for Medicare & Medicaid Services (CMS), lower back pain is widely ascribed to "a multitude of causes, such as mechanical and non-mechanical factors." CMS also cited a source that asserted that the "neurophysiologic mechanisms of pain sensation are poorly understood."

The proposed decision memo also described lumbar disc imaging as offering little clarification due in part to "the anatomic complexity of the spine and poor understanding of neurophysiologic mechanisms of pain sensation." CMS concluded "the growing incidence of nonspecific low back pain in the Medicare population" and "a lack of self-assessed improvement in the patient population with spine problems ... despite the rapid progression and adoption of new technologies to the spine market, cause great concern."

The agency characterized the mechanism of action of TIP technology as theoretical, given the failure of such therapies to distance themselves statistically from sham procedures in a multitude of studies. Hence, CMS "propose[s] that TIPs are not reasonable and necessary." The agency will post a final decision memo Oct. 13.