Regulation and Compliance
 FDA held a public meeting on blood glucose meters in March of this year; the agency is very pleased with the level of discussion and input that was generated at the meeting.  Courtney Harper, director of the division of chemistry and toxicology devices at CDRH, the division that hosted the meeting, cited 12,000 measurement errors reported each year by users of blood glucose meters (BGMs) and said that the meeting was “a way for FDA to try to take a new approach to addressing...
IVD manufacturers are accustomed to risk. Taking risks is part of their business. Companies develop plans to identify and mitigate risks, from product development to finished product manufacturing. While risks cannot be eliminated, generally they can be recognized and managed. One category of risks—regulatory risks—is well-known and can readily be characterized. The U.S. Securities and Exchange Commission filings for IVD companies routinely spell out their regulatory risks. When...
Australia's Therapeutic Goods Administration (TGA) is planning to implement a new risk-based regulatory framework for in vitro diagnostic medical devices during 2010. The regulatory framework is based on the recommendations of the Global Harmonisation Task Force (GHTF). Australia will be the first GHTF founding member to implement a GHTF-based system for IVDs. The proposed framework will regulate IVDs as a subset of medical devices and will amend the current Therapeutic Goods (Medical Devices...
The Gray Sheet reported that FDA Commissioner Margaret Hamburg signed the orders that officially moved the Radiological Devices Branch from the Office of Device Evaluation (ODE) to the Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD). FDA hopes that doing so will produce more cohesive policies on diagnostic device review. Issues under the jurisdiction of the radiological branch, which regulates diagnostic imaging equipment and other radiation-emitting devices, have been a...
 FDA held a public meeting on February 9, 2010, requesting comments on how CDRH should anticipate and respond to new or evolving scientific knowledge in a manner that is consistent with its mission to protect and promote the public health. Concurrently, the agency is promoting transparency via a task-force process.     To accelerate products to market, OIVD needs to take the following actions to improve transparency.   First: Issue a Blue Book memo stating that...
Risk management is a new area of focus for the Clinical and Laboratory Standards Institute (CLSI). Three CLSI documents, EP18, EP22, and EP23, provide a foundation for clinical laboratories to develop quality control plans based on risk management. Risk management is defined as the systematic application of management policies, procedures, and practices to the tasks of analyzing, evaluating, controlling, and monitoring risk (ISO 14971).1 IVD manufacturers are familiar with risk management...
 Prompted in part by the healthcare reform efforts underway in Washington, AdvaMed has created a new division specifically for IVD companies: AdvaMed Dx. The division sees itself as an association within an association that maintains access to and support from AdvaMed. Already attracting such high-profile members as Gen-Probe and bioMerieux, AdvaMed Dx is governed by an 18-member Board of Directors and an eight-member Executive Committee, both of which comprise IVD-company CEOs. The Board...
People make mistakes all the time. To err is one of the well-recognized characteristics of being human. Alexander Pope is credited with having written, “To err is human, to forgive divine.” In our highly complex society, we might rightly expand on Pope to say, “To err is human; to really mess up takes a system with a convoluted user interface.” Unfortunately, in medical technology, as well as in other safety-critical systems, mistakes can lead to serious, often...
One need only peruse issues of IVD Technology magazine from the last decade to appreciate the tremendous development and advancement of biotechnology-based IVDs. Although regulators such as FDA have instituted forward-leaning policies and programs such as FDA’s Critical Path Initiative to facilitate medical product development, implementation of these programs has been uneven. One area badly in need of more focused and enlightened regulation is point-of-care test (POCT) IVDs; in...
          Photo by iStockphoto Last July, Alberto Gutierrez, PhD, was appointed the new director of the Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD). According to OIVD officials, Guttierez's appointment is effective immediately. He took over the position that had been vacated by former director Steven I. Gutman, MD, PhD, who stepped down last year.   Gutierrez received a bachelor's degree from Haverford College, and master and...