Devicemakers Given Three Years to Transition to New Standard

From  FDA News Devices & Diagnostic Letter March 29, 2010

Devicemakers may have to pay up to 40 percent more to test the safety and effectiveness of electronic devices now that CDRH has adopted an international standard for electronic devices.

Manufacturers will have three years to comply with the third edition of the International Electrotechnical Commission’s (IEC) 60601-1, Carol Herman, director of standards management at CDRH, said at a recent Association for the Advancement of Medical Instrumentation (AAMI) conference. The agency hopes to publish a notice of the change in the Federal Register by June, she added.

Many Changes

The complex standard sets general requirements for basic safety and essential performance of medical electrical equipment. Unlike most revisions, which average three to five major changes, the third edition of the IEC standard includes 114 subclauses not listed in the second edition, introduced in 1988, John Drengenberg, consumer affairs manager at Underwriters Laboratories, told D&DL.

The new standard allows devicemakers to employ less stringent requirements for operator safety, mechanical safety factors and surface temperatures, Frank O’Brien, president of O’Brien Compliance Management, told D&DL. But for electronic devices on wheels, the standard includes more stringent requirements for stability and rough handling.

The standard also allows devicemakers to use components, such as power supply units, designed for the IT industry, which could offset other costs, Mike Schmidt, co-chairman of AAMI’s electrical safety committee, told D&DL.

To help devicemakers transition to the new standard, CDRH plans to release two guidances. The first, which should come out sometime this year, would cover general principles of how to use the standard based on the FDA’s perspective of safety and effectiveness, Leo Eisner, a safety consultant who has worked with FDA officials, told D&DL.

The second guidance, which will not be issued until the FDA determines what changes to make to its 510(k) and PMA processes, will advise manufacturers on what information will be required in marketing applications for electronic devices, he said.

Harmonizing Standards

CDRH’s adoption of the IEC standard was inevitable given the FDA’s push to harmonize its regulations, Steve Strong, vice president of quality assurance and regulatory affairs at Minnetronix, told D&DL. Minnetronix specializes in the design and manufacture of electronics-based devices.

With Canada, Europe and the U.S. in various stages of implementing the IEC standard, 75 percent of device regulators should be in alignment with the provision by 2013, O’Brien said.