Regulatory Editor

It may be a no-brainer that devices and drugs have little in common, but the European Network for Health Technology Assessment (EUnetHTA; Brussels) has cobbled together a set of guidelines for therapeutic device-specific health technology assessment. While the document acknowledged that randomized, controlled trials might not always be available due to practical considerations, the authors of the document nonetheless hold that registry data would be useful in an assessment only for determining long-term outcomes, and only when the underlying registry study addresses residual confounding.

Device makers might not commonly see registry studies as a routinely available tool in the development of premarket evidence for regulatory review, but the FDA push for registries and other components of a post-market surveillance system suggests the agency holds a more expansive view of registry studies. Jeff Shuren, director of the Center for Devices and Radiological Health, has on more than one occasion made the point that unique device identifiers and registry studies could be leveraged so as to be useful in the premarket realm as well, including in his blog at FDA Voice dated Feb. 23, 2015.

Whether other national regulators see the issue the same way is not clear, but the EUnetHTA document indicated that this view is not universally held, at least not by some of those responsible for health technology assessments (HTAs).

The guidelines include a range of recommendations for assessment of therapeutic devices, but commenced with an acknowledgement that while the principles governing pharmaceutical HTAs are also applicable to devices, several considerations must be addressed. One is that "the rapid development [of newer devices] also poses a challenge to trial design," but also that outcomes often hinge on "the skills and experience" of the user.

The third recommendation addressed in part the evaluation of a categories of devices, which the authors said would require an effort to highlight "potentially important differences" between the inhabitants of that category. Another note for this type of assessment is the potential need for "redefinition of the intervention [that] may become necessary during the course of the assessment."

The authors made note of a preference for randomized, controlled trials, but added in the sixth recommendation that disease- or device-specific registries along with incident-reporting databases can also be used to inform an HTA. However, the document stated that a registry data set must account for residual confounding, and further stipulated that analyses of registry data "should only be used for assessment of [long-term] treatment effect" only when "appropriate confounder control is possible."

Institutional and operator experience also come into play in the EUnet document, with the seventh recommendation being that any HTA account for both, although the authors add that user proficiency and health care setting "may affect both intervention and comparator" device/therapy.

The authors listed three major issues for comparative effectiveness assessment, including the stand-by of device iteration, but user dependency and any device-associated learning curves are also on the list. The document further makes reference to a comparative effectiveness statement by MedtecHTA in the context of literature searches.

Invo Bioscience scores de novo win

Invo Bioscience (Medford, Mass.) snared a win for its Invocell intravaginal culture system in an effort that required nine months to complete from the date of the filing of the application. The device carries the intended use of transfer of gametes and embryos during in vitro fertilization with a maximum hold time of 72 hours, according to the FDA approval order.

The agency stated in the associated Federal Register notice that the device classification was in force as of Nov. 2, 2015, thanks to the addition of section 884.6165 to chapter 21 of the Code of Federal Regulations. The list of special controls for the category of intravaginal culture system includes a determination of the maximum number of gametes/embryos that can be placed in an applicant device.

The FDA stated that Invo had filed the application Feb. 23, 2015, and the company statement announcing the granting of the de novo stated that 6.7 million couples in the U.S. struggle with fertility issues, fewer than one in ten of whom are able to conceive. The statement offered no information on coverage or reimbursement for the associated procedure.

FDA reopens hearing aid draft comment period

Federal agencies are sometimes accused of being deaf to the pleas of patients and device makers, but the FDA announced Jan. 6 that it is reopening the comment period for hearing aid and "personal sound amplification" devices to address a draft guidance with more than two years of accumulated dust. The reopening of the comment period was accompanied by an FDA statement making note of an upcoming workshop on the subject of the agency's regulation of such devices along with an acknowledgement that a large majority of the hearing impaired never avail themselves of such devices.

The FDA said the workshop will take place April 21 at the agency's campus in Silver Spring, Md., adding that NIH analyses suggest that only 30 percent of those 70 and older and 16 percent of those aged 18 and older have ever used a hearing assistance device.

The FDA announcement further referred to a White House report that made note of high unit cost and poor health care coverage for such devices. The report argued additionally that the FDA regulatory regime places additional impediments to utilization, including the fact that the agency requires a prescription despite that patients can obtain a waiver for an evaluation of their hearing impairment. The report added that the incidence of acoustic neuromas, which can cause hearing loss, is one in 90,000 whereas the incidence of glaucoma is 3.54 percent. "This has not prevented reading glasses from being sold over the counter," the report's authors observed. The report added the recommendation that the FDA preempt state requirements that hearing aids be dispensed only by credentialed dispensers.

The docket for the draft guidance is open under docket number FDA-2013-D-1295 for 120 days after the Federal Register notice, presumably May 5 given the formal FR notice date of Jan. 7. //

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