Tag Archives: medical devices

Keeping Up With Mobile App Innovations

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By: Christy Foreman

A smart phone that can perform an electrocardiogram (ECG)—measuring the electrical activity of a person’s heart to determine whether he or she is having a heart attack—is in my opinion an extremely smart phone. That is just one example of how mobile medical applications are transforming health care.

As we testified today before Congress, FDA has no intention of stifling innovation in this exciting and rapidly growing field. The fact is, only a fraction of mobile apps would require FDA review. However, when a mobile app is doing the job of a medical device that requires FDA clearance or approval, it’s only logical that both should be governed by the same rules. These are the small percentage of mobile apps that pose a risk of serious illness or death to patients. With these considerations in mind, FDA in coming weeks will be issuing a final guidance document that will help companies determine whether their product will require FDA clearance or approval.

They would be limited to mobile apps that meet the definition of device and are intended for use: 

  • to transform a mobile device into a medical device already regulated by FDA
  • as an accessory to a medical device already regulated by FDA

In addition to the smart phone that performs an ECG, other examples include a mobile medical app that controls the delivery of insulin; another that acts as a stethoscope; a mobile medical app that takes patient-specific information and provides a clinician with radiation dosage calculations, and mobile medical apps that allow doctors to view X-rays or other imaging on smart phones and tablets.

These examples show why FDA has a public health concern about the potential consequences of a malfunctioning mobile medical app. 

FDA’s Center for Devices and Radiological Health has been reviewing mobile medical apps for more than 10 years and in that period we have reviewed about 100 applications and each review has taken about 60 days to complete. We’re confident that the center has the expertise to continue the timely review of the small number of submissions we expect to receive from mobile app developers.

Our final guidance will be informed by some 130 public comments, most of which were overwhelmingly supportive of our risk-based, narrowly-focused approach proposed in the draft guidance. Once the guidance is released, we are confident that the public will see that it represents a careful balance between the need to encourage innovative technology with our mission of providing reasonable assurance that medical products are safe and effective.

Christy L. Foreman is Director, Office of Device Evaluation, at FDA’s Center for Devices and Radiological Health

FDA Commemorates 30th Anniversary of the Orphan Drug Act

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By: Gayatri R. Rao, M.D., J.D.

Gayatri R. Rao, M.D., J.D., is Director of FDA's Office of Orphan Products Development

When President Reagan signed the Orphan Drug Act 30 years ago, he enacted a critically important piece of health care legislation. The passage of this Act on January 4, 1983, was monumental because it created—for the first time—incentives to develop desperately needed medical products for Americans suffering with rare diseases. Until that point, development of such products was very limited. For instance, in the decade leading up to the passage of the Orphan Drug Act, only 10 industry-supported products for rare diseases were brought to market.

The Office of Orphan Products Development (OOPD) was formed at FDA more than 30 years ago, prior to the passage of the Orphan Drug Act, because FDA recognized that rare diseases, when taken together, posed a significant national public health issue. Once the Orphan Drug Act was passed, OOPD became responsible for administering the incentive programs created to spur the development of medical products for rare diseases, namely the Orphan Drug Designation Program and the Orphan Products Grants Program. These products include drugs, biologics, medical devices, and medical foods for the treatment of rare diseases.

As FDA commemorates the passage of this important legislation, we look back over the last 30 years with pride. Since its passage, over 2700 products in development have been designated as orphan drugs through the Orphan Drug Designation Program and over $290 million has been awarded to clinical studies through the Orphan Products Grants Program.  These programs, along with the critical, collective efforts of the Center for Drug Evaluation and Research’s (CDER) Rare Diseases Program, and those of many individuals across FDA, have helped to bring over 400 orphan products for rare diseases to the market.

We also commemorate the more than 30 years of dedicated service from every member of the rare disease community:

  • the patient advocates, who spurred national awareness about the challenges that people with rare diseases face and who continue to support families, educate the community, and drive research into their diseases;
  • the legislators who heard the voices of rare disease advocates and worked to champion the passage of the Orphan Drug Act;
  • the research community, which continues to leverage resources and foster collaborations among academia and industry stakeholders;
  • the clinicians, who support the medical needs of families with rare diseases and work to advocate on behalf of the community;
  • and industry, including pharmaceutical and biotech companies, angel investors, and venture capitalists who, in the spirit of the Orphan Drug Act, have come together to develop products for rare diseases.

Our many successes give us a reason to celebrate 30 years of hard work to provide diagnostic or treatment options to those with rare diseases. But we are keenly aware that there is still a challenging road ahead. We at FDA remain firmly committed to working with the rare disease community to tackle those challenges and to find new diagnostic tools and treatments for the millions of patients with rare diseases.

Gayatri R. Rao, M.D., J.D., is Director for The Office of Orphan Products Development