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Medical Device Approval Changes Outlined by FDA for 2011

By Rheingold Giuffra Ruffo Plotkin & Hellman LLP

The system used by the Food and Drug Administration (FDA) to grant market approval of medical devices is slated for some updates in 2011. The bureaucracy’s current methods have been in place for 35 years, and changes have been strongly encouraged by public safety advocates. Key aspects of the proposed changes include streamlining processes for lower-risk devices, enhancing the role of clinical data and ensuring consistent science-based deliberations.

Not surprisingly, the medical device industry’s primary trade group has lobbied against the proposal. AdvaMed, whose member companies include Boston Scientific, Medtronic, Novo Nordisk and other industry giants, released a statement late in 2010 alleging that changes “could result in a significant disruption to a program that has served patients well for more than 30 years.”

The FDA has acknowledged consumer concerns that the existing system, known as the 510(k) program, “did not provide adequate assurances of safety and effectiveness nor did it provide sufficient information for healthcare providers and patients to make well-informed treatment or diagnostic decisions.” One particular concern is that the current system has failed to keep pace with the increasing complexity of medical devices.

A safe and efficient system of medical device approval requires vigilance and periodic adjustment to reduce the potential for serious and widespread harm to innocent patients. Devices need not be defective to be dangerous – improper instructions or making devices too broadly available can cause significant complications. When a prolonged illness or wrongful death is the result, the victim or surviving family members need quick answers and swift action.

Product Liability Lawyers Offer Clear Advice to Victims of Defective Medical Devices

A variety of high profile medical device defects have required aggressive intervention from personal injury attorneys to bring light to hazards and ensure justice for injured patients. Guidant implantable defibrillators, Medtronic Quick Set infusion sets, DePuy ASR hips, Kugel Mesh, NuvaRing contraceptives, ReNu MoistureLoc contact lenses and Zimmer Durom cups are several prominent examples.

Private legal action is an important check on threats to public health because bureaucratic solutions can never anticipate every problem. The same reasoning applies to defective drugs and medical malpractice actions – when the system fails to provide unfailingly safe health care options, individuals often suffer serious harm and deserve significant compensation. But maintaining a strong system of government oversight is just as important, and watering down reform to appease corporate concerns can ultimately prove dangerous to patients.

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