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A February ruling by the Federal Communications Commission that will allow the use of certain software to test the transmitter designs in medical devices could speed device development times and reduce costs for manufacturers, according to the chief maker of the simulation software, ANSYS Inc.
The FCC ruling specifically granted a waiver to ANSYS that allows the use of its High Frequency Structure Simulator (HFSS) software to simulate a medical device that must communicate with other similar devices as part of the transmitter testing requirements, ANSYS said in an early March statement. In particular, the testing using the HFSS software is done using the “finite element method,” ANSYS said.
FCC rules require that transmitters in medical devices used on, in, or near the human body must be tested to ensure they do not emit harmful levels of radiofrequency energy. Transmitters in medical devices are used to send data from devices wirelessly to other devices used by health care providers in monitoring, diagnosing, and treating patients.
Canonsburg, Pa.-based ANSYS had argued to the FCC that the finite element method (FEM) of simulating medical devices for the testing requirements was a valid analysis technique for producing results needed to accurately measure radiofrequency.
In its ruling, the FCC said it agreed with ANSYS's assertion and noted that “academic and industry literature” supported the claim.
Attorney Keith Barritt, with Fish & Richardson PC in Washington, told BNA March 14 that the FCC ruling would be helpful to medical device manufacturers, but cautioned that it was not certain whether the Food and Drug Administration would accept FEM technique.
“It is always good for industry to have options when demonstrating compliance with FCC rules, and for some manufacturers the waiver may present a significant improvement over alternative evaluation techniques,” Barritt said.
“Of course, for medical device manufacturers, meeting FCC requirements is only half the battle. Considering the new cooperative agreement between FCC and FDA announced last summer, hopefully the FDA will not question use of this new measurement technique to meet its relevant requirements for marketing authorization.”
In July, FCC and FDA announced a partnership to promote wireless medical technology, a field they say can reduce health care costs for all Americans. The heads of the two agencies signed a memorandum of understanding and released a joint statement of principles at that time. Among the goals of the memorandum of understanding was to improve the efficiency of the agencies' regulatory processes where their jurisdictions overlap.
The ruling is available at http://www.fcc.gov/Daily_Releases/Daily_Business/2011/db0201/DA-11-192A1.txt.
The FCC-FDA memorandum of understanding is available at http://www.fcc.gov/Daily_Releases/Daily_Business/2010/db0726/DOC-300200A2.pdf.
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