Regulation and Compliance
On June 13, the Supreme Court issued its long-awaited decision in Association for Molecular Pathology v. Myriad Pharmaceuticals, Inc. In a 9-0 decision, the Court ruled that naturally occurring human genes are not patent-eligible subject matter under the U.S. Patent Act, but cDNA can be patented. The Court did not address Myriad patents covering genetic testing methods based on specific mutations in human genes. The full decision is available online. The Myriad decision has caused a fair degree...
Clinicians often place a great deal of blind faith in the results of IVD medical devices. Staff assumes if a device gives a result, then that result must be correct. Glucose meters, pregnancy tests, blood gas analyzers and coagulation devices are all considered equivalent to central laboratory instrumentation, only faster. Yet, central laboratory testing is conducted under well monitored and controlled conditions, while these point-of-care testing (POCT) devices are subjected to a variety of...
The basic promise of personalized medicine is predicated in large part on the expanding availability of biomarker-based testing, and FDA-approved tests offer the broadest market for any biomarker that is to be developed into an IVD. Approval trends for biomarker-based IVDs are thus among the best objective measures of progress in advancing personalized medicine. A new report that reviews trends in approvals of 510(k) and premarket approved molecular IVDs shows an appreciable decline in the...
A two-tiered regulatory scheme currently imposed on sponsors of new point-of-care (POC) IVDs, particularly devices intended for the physician office laboratory (POL), was characterized as unduly burdensome in a column titled, “CLIA-Waived Tests: Is There Another Way?” published in the March/April 2010 issue of IVD Technology. In brief, a prospective sponsor of a new POL test not only must secure FDA clearance but, in many cases for marketing reasons, also must obtain CLIA...
Manufacturers of IVD devices should be aware of three proposed Global Harmonization Task Force guidance documents on clinical evidence for IVD devices. The documents cover definitions and terminology, determining scientific validity, performance evaluation, and clinical performance studies. The Global Harmonization Task Force (GHTF), created in 1992 in an effort to promote the international harmonization of medical device regulation, is a voluntary group of representatives from national medical...
  Well, it finally arrived. The long-awaited and perhaps feared new EU text that will regulate all in vitro diagnostic products on the EU market is available on the EU website. Industry was apprehensive about the repercussions of the PIP breast-implant and metal-on-metal prosthesis scandals on the regulations. At one point, there were even rumors that the whole EU legislative system would abandon “new approach” principles in favor of a rigid pharma-like pre-market approval...
FDA issued draft guidance on August 15, 2011, that addresses design of pivotal clinical trials for medical devices. The comment period expired November 14, 2011. There are no surprises in this guidance. The principles of trial design that are discussed are standard techniques that have been used to evaluate clinical utility of medical devices for many years. The guidance does make clear that FDA expects device manufacturers to be as rigorous in design of clinical trials as drug and biologic...
We are entering a bold new period for personalized medicine and molecular IVDs, highlighted by the AMA’s approval of more than 100 new genomic test codes for 2012. But there are still some urgent problems in our regulatory and reimbursement policy arenas. The regulatory problem is the disincentive that our mixed environment of approved IVDs and competing laboratory-developed tests (LDTs) impose on IVD companies that make long-term investments in product development and FDA submissions...
The decision tree is designed to assist manufacturers in the qualification of stand-alone software as an IVD device. The European Commission recently published “Guidelines on the Qualification and Classification of Stand Alone Software Used in Healthcare within the Regulatory Framework of Medical Devices.” The MEDDEV guidance document addresses all of the medical device directives and includes two convenient decision trees to determine whether particular software is...
IVD medical devices are extremely important products for which performance evaluation studies can provide necessary evidence on safety and performance. Part 1 of this article discussed European requirements related to performance evaluation studies. Part 2 discusses considerations when planning studies where results will be used for both CE marking and U.S. approval and clearance. European and U.S. terminology differences The term “performance evaluation studies” is used for...