Lori A Carr

GlobalData analysts anticipate that new cholesterol treatment guidelines will be “hard to swallow” for manufacturers of other lipid-lowering drug classes, such as Merck’s & Co.’s Zetia and AbbVie’s Trilipix as the new recommendations all but discredit the usefulness of these products.  Despite this, GlobalData analysts say that the updated guidelines for treating hypercholesterolemia and atherosclerotic cardiovascular disease (ASCVD) could give the statin market a substantial boost in the coming years.

 US Food and Drug Administration (FDA) officials quietly announced late on a Friday in November that their biologics online submission system had been “compromised” by an unauthorized user—hacked, in common parlance—leading to the access of users’ account information, e-mail addresses and passwords.

The World Health Organization and Health Care Without Harm, an international coalition of 473 entities in 50 countries, are calling for a global phase-out of mercury-containing fever thermometers and blood pressure cuffs by the end of this decade.

Through the Case for Quality, the FDA is working with stakeholders—industry, healthcare providers, patients, payers, and investors – to foster medical device quality.  Enhancing the quality of medical devices is in the best interests of all, especially industry and patients.  This is achieved by identifying and promoting practices that result in high-quality devices and adapting FDA regulatory approaches to align with those practices.  Ultimately, this provides stakeholders with understandable and objective information about medical device quality; facilitates medical device innovation and quality through data and analysis on device performance; and fosters strategies that focus stakeholder interactions on device quality.

The China Food and Drug Administration plans to step up its tracking of medical device adverse events in hospitals, and is asking high-risk and Class III device makers to refer to a 2011 guideline on electronic monitoring to facilitate submission of incident reports.

A recent decision by the EU Court of Justice on borderline products affirms a practice by member states that can pose challenges for devicemakers, says Erik Vollebregt of Axon Lawyers in the Netherlands. The court ruled in case C-109/12 that individual member states may classify the same product differently, whether as a medicinal product requiring clinical data or as a medical device.

The International Medical Device Regulators Forum will launch its medical device single audit program (MDSAP) pilot in January in the U.S., Canada, Australia and Brazil.  The program will run for three years in pilot phase and has the potential to overhaul inspection and enforcement activities in the participating countries.  For devicemakers, the benefit is that a single inspection could eventually serve all IMDRF nations, taking the place of the routine audits currently conducted separately. Preapproval for-cause and compliance follow-up audit responsibilities would be retained by member nations in most cases.

Medical device market regulators in Australia, Brazil, Canada and the US are preparing to launch a pilot for their Medical Device Single Audit Program (MDSAP) in January 2014.

The European Parliament has voted in favor of implementing stricter requirements for Notified Bodies, but not for recommended medical device registration reforms that would create an approval process similar to Premarket Approval in the US.

The Advanced Medical Technology Association (AdvaMed), an association of international medical device manufacturers, has urged the Parliamentary Standing Committee on Health and Family Welfare to consider its recommendations for the Drugs & Cosmetic (Amendment) Bill 2013 (known as the medical devices bill) so that the benefits of the bill can result in faster and safer solutions for Indian patients and more investments for the country.