Nanoscale materials are popping up more frequently in our lives, and FDA has reacted with an agency-wide guidance to provide a framework for determining whether a product's parts or ingredients constitute nanotechnology. The question of FDA regulation of nanoscale materials has been brewing for nearly a decade, but the focus of this guidance seems limited to characterization, and includes little in the way of product-specific information, a predicament the agency conceded in the passage, noting that issues such as safety and regulatory status of an affected product "are currently addressed on a case-by-case basis using FDA's existing review processes."
FDA first formally acknowledged the nanotech policy issue with the formation of a task force eight years ago (Medical Device Daily, Aug. 10, 2006), but the question of whether the agency was sufficiently resourced to investigate the question exhaustively at that time arose during a public meeting on the topic later that year (MDD, Oct. 12, 2006). The guidance – which does not indicate its a status as a draft guidance but as a final guidance – suggests the agency sees "a need to learn more about the potential role and importance of dimensions in the physical and chemical characteristics and biological effects exhibited by FDA-regulated products."
The guidance acknowledged some issues associated with the proposition that 100 nanometers serves as a hard upper boundary for the definition of a nanoscale component or ingredient, stating that the physical and chemical properties and the biological behavior ordinarily attributed to nanoscale materials may be exhibited by materials "outside the nanoscale range" of 1 to 100 nanometers.
FDA indicated that any materials that can be measured within that span, either as an external or an internal dimension, will be considered to have the potential to exhibit the properties unique to nanoscale materials. However, the agency also noted that it is "particularly interested in the deliberate and purposeful manipulation and control of dimensions to produce specific properties," which the guidance said is a different regulatory proposition than products that inherently occur at the nanoscale range. FDA indicated it is not focused on particles in the nanoscale range that are the result of conventional manufacturing techniques.
The agency is accepting comments to the docket on an ongoing basis under docket number FDA-2010-D-0530.
FDA inks new final GUDID guidance
Scarcely two weeks have passed since FDA published a purportedly final guidance on the global unique device identifier database (GUDID) when the agency released another final guidance. The agency's explanation was that it had released the June 11 edition "in order to provide labelers access to the latest information" as soon as it was available and address the most common questions filed for the Sept. 24, 2013 draft.
The new final guidance, however, "finalizes the remaining sections and incorporates sections finalized earlier in order to provide one complete and final document," the agency said. However, FDA indicated it "intend[s] to periodically update this document to reflect [GUDID] system changes and enhancements."
The guidance reminds the reader that manufacturers can fill out their GUDID entries via the GUDID web interface or, in the case of high-volume entities, a structured product labeling utility provided by Health Level 7 (HL7; Ann Arbor, Michigan), available at the agency's electronic submissions gateway. The HL7/FDA utility uses XML to fill out the database.
Affected entities will have to set up a GUDID account, and FDA recommends that each account have "one or more [designated] coordinators" who would serve as the agency's first point of contact in the event of questions about a GUDID entry. The agency said that each account "may have zero or more third-party submitters," although the account holder is liable for all GUDID data.
HydroFinity wires a class I recall
FDA announced June 25 a class I recall of nitinol hydrophilic guidewires manufactured by Nitinol Devices & Components (ND&C; Fremont, California) under the HdyroFinity brand due to the potential for damage to the device's outer polymer jacket. The recall affects all HdyroFinity lots distributed by Covidien (Dublin, Ireland) between Nov. 30, 2013, and May 14.
FDA explained that the recall, announced by ND&C May 28, was triggered by a dozen reports of polymer jacket separation. Embolization occurred in two instances, one of which required surgical intervention, according to the agency.
OIG eyes lab-to-doc payments
The Office of Inspector General (OIG) indicated a concern about payments made by operators of clinical labs to physicians, referring to two recent trends OIG believes "present a substantial risk of fraud and abuse under the anti-kickback statute."
OIG's June 25 alert said that the agency has "become aware of arrangements" in which clinical labs pay physicians to collect, process and package blood specimens, noting that the current procedural terminology (CPT) code for Medicare billing changes when going from collection to collection, handling and conveyance of the specimen(s). The agency indicated concern regarding practices in which a clinical lab pays a physician for such services in excess of fair market value, and when payment is made for each specimen drawn or on another basis "that takes into account the volume or value of referrals."
Also deemed problematic are arrangements in which physicians forward data to registries on behalf of a clinical lab, an arrangement OIG said "may induce physicians to order medically unnecessary or duplicative tests" or to order those tests from labs that offer registry arrangements "in lieu of other potentially clinically superior labs." //