In a previous FDAImports.com article on the Japan Earthquake it was stated that FDA-regulated products from Japan will likely face many new hurdles in order to enter the United States. FDA will likely subject them to greater regulatory review by inspecting incoming food, drugs and medical devices and possibly subjecting them to laboratory testing.
On June 1, 2011, the Center for Device and Radiological Health (“CDRH”) and the Center for Biologic Evaluation and Research (“CBER”) issued a joint-letter that clarifies FDA’s concerns about medical devices and electronic devices coming from Japan. In the letter, CDRH and CBER advised the industry to take increased precautions to assure that medical devices are safe and effective. However, this letter serves as an important tool for importers because it allows them to appreciate which dangers and medical devices FDA is particularly concerned about.
CDRH and CBER expressed concern about two dangers that could affect any medical devices. First, FDA is concerned about the risks associated with radiological contamination. Second, FDA is concerned about the risks associated with water exposure. Water exposure encourages mold growth. Also, the water may have had contaminants that may have affected the medical device. Both instances represent safety concerns for FDA.
In the letter, CDRH and CBER expressed a concern about specific medical devices.
1. Medical Devices With Electrical Components: The water exposure may have compromised the electronic component, thereby making the device ineffective and/or unsafe.
2. Medical Devices With Animal-Derived Components: These medical devices present a greater risk of radiological contamination, because the animal may consume contaminated feed or water. Then, this contamination may subsequently appear in the medical device.
3. Medical Devices Requiring Temperature Controls: The power outages that occurred as a result of the devastating earthquakes and tsunami in Japan may be to blame as certain medical devices depend on constant temperature controls.
4. Sterilized Medical Devices: Between water damage and power outages, the medical device may have become unsterilized and thereby unsafe.
Although FDA will likely focus its attention on these risks and specific medical devices, it will not ignore other regulatory concerns, such as labeling violations, improper claims and standard medical device FDA guideline violations. Therefore, manufacturers and importers should be ready for increased scrutiny from the FDA.
By understanding FDA’s concerns, manufacturers and importers can better prepare for FDA’s increased scrutiny long before placing any medical device on a ship or an airplane. First, prior to importation, they should more strenuously test their medical device to verify its regulatory compliance in light of FDA’s concerns.
Second, they should document this verification. FDA may detain the medical device alleging that it appears to violate FDA regulations. With verification documents ready, the importer can move more quickly through the FDA-detention process.
– Benjamin L. England, Founder
