Bloomberg BNA's Health IT Law & Industry Report brings you concise, comprehensive, and timely news and analysis of the regulatory, legal, and compliance issues surrounding our nation’s...
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.
All Bloomberg BNA treatises are available on standing order, which ensures you will always receive the most current edition of the book or supplement of the title you have ordered from Bloomberg BNA’s book division. As soon as a new supplement or edition is published (usually annually) for a title you’ve previously purchased and requested to be placed on standing order, we’ll ship it to you to review for 30 days without any obligation. During this period, you can either (a) honor the invoice and receive a 5% discount (in addition to any other discounts you may qualify for) off the then-current price of the update, plus shipping and handling or (b) return the book(s), in which case, your invoice will be cancelled upon receipt of the book(s). Call us for a prepaid UPS label for your return. It’s as simple and easy as that. Most importantly, standing orders mean you will never have to worry about the timeliness of the information you’re relying on. And, you may discontinue standing orders at any time by contacting us at 1.800.960.1220 or by sending an email to firstname.lastname@example.org.
Put me on standing order at a 5% discount off list price of all future updates, in addition to any other discounts I may quality for. (Returnable within 30 days.)
Notify me when updates are available (No standing order will be created).
This Bloomberg BNA report is available on standing order, which ensures you will all receive the latest edition. This report is updated annually and we will send you the latest edition once it has been published. By signing up for standing order you will never have to worry about the timeliness of the information you need. And, you may discontinue standing orders at any time by contacting us at 1.800.372.1033, option 5, or by sending us an email to email@example.com.
Put me on standing order
Notify me when new releases are available (no standing order will be created)