Regulation and Compliance
In the November/December 2010 issue of IVD Technology, I discussed moves made by FDA to regulate laboratory-developed tests (LDTs, formerly known as “home brews”). Examples of inadequate LDTs were formally submitted to FDA in Genentech’s December 2008 Citizens’ Petition, but the agency’s discomfort with LDTs has a long history. New guidance documents and presentations in recent months have sought to clarify FDA’s intentions and produced many responses...
After more than 35 years of industry and FDA device and diagnostic evolution, it remains difficult to measure regulatory effectiveness because we are still seeing a moving target in submission reviews and enforcement. Examples include performance testing, clinical data, and quality system regulation (QSR)-related information and claims. While the FDA-requested Institute of Medicine report published last summer called for a rewrite of the 510(k) process, in part based on perceived 510(k) process...
Congressman Leonard Lance (R-NJ) introduced legislation to promote the development of meaningful treatments for patients with chronic or rare diseases. The “Modernizing Our Drug and Diagnostics Evaluation and Regulatory Network (MODDERN) Cures Act” (HR 3497) would modernize the U.S. drug and diagnostics evaluation and regulatory network by encouraging the discovery and development of new treatments for the many diseases that have few or no options. It would also create a...
Late last year, FDA issued its guidance for industry and FDA staff titled “Enforcement Policy for Premarket Notification Requirements for Certain In Vitro Diagnostic and Radiology Devices.” In the guidance document’s introduction, FDA states that it proposes the “downclassification” and exemption from 510(k) requirements of the Class II devices that are the subject of the document because the safety and effectiveness of those devices is sufficiently...
IVDs are extremely important healthcare products for which performance evaluation studies can provide necessary evidence on safety and performance. Part 1 of this two-part column discusses European requirements related to performance evaluation studies. Part 2 will discuss issues to consider when planning studies, in which results will be used not only for CE marking but also for clearance or approval in the United States. European definitions and implications Article 1(e) of the European In...
Back in late July of this year, the Institute of Medicine (IOM) recommended that FDA replace the 510(k) medical-device clearance process with something brand new. (Under current regulation, to obtain 510(k) clearance, a manufacturer must demonstrate that the device is substantially equivalent to a device that was in legal commercial distribution in the United States before May 28, 1976, or to a device that has been determined by FDA to be substantially equivalent.) The committee stated that FDA...
FDA released its draft guidance on in vitro companion diagnostic devices. The guidance is intended to assist companies that are planning to develop a drug that depends on the use of a companion diagnostic for its safe and effective use as well as those companies that are planning to develop a companion diagnostic that is intended to be used with a corresponding drug. Industry analysts were positive in their overall assessments of the guidance. “The draft guidance is helpful in several...
The European Directive 98/79/EC on in vitro diagnostic medical devices, or IVD Directive (IVDD), became operational in June 2000.1 It provides Europe with one single regulation for in vitro diagnostics (IVD). Devices receiving the CE mark after one successful conformity assessment procedure can be introduced into the member states of the European Union and the European Free Trade Association, and two countries with which mutual recognition agreements have been established (Switzerland and...
In March, FDA’s Molecular and Clinical Genetics Panel held a meeting to discuss and make recommendations on scientific issues concerning direct-to-consumer (DTC) genetic tests that make medical claims. FDA opened the meeting with a presentation outlining the history and landscape of DTC clinical genetic tests. FDA ended its introductory presentation by providing the current challenges and rationale for the meeting: to hear perspectives from broad panels of experts, invited...
Reactions to FDA’s proposed Innovation Pathway, part of its new Medical Device Innovation Initiative, are mixed. The Innovation Pathway, if instituted, will be a “priority program for new, breakthrough medical devices,” according to FDA. It is one component of a broader effort by CDRH to “encourage cutting-edge technologies among medical device manufacturers.” The first product submission for this review program is a robotic prosthetic arm being developed by DARPA...