FDA lowers regulatory hurdle for digital mammography

For the vast majority of medical imaging devices, passing FDA review is a snap: Show equivalence to a device already on the market, wait a few months, and release the announcement that your new product is ready for U.S. patients. But not for full field digital mammography systems.

Since the first FFDM – the GE Senographe 2000D – passed FDA muster nearly 11 years ago, every FFDM device has had to go through the premarket approval system, a lengthy and often torturous process akin almost to the drug approval process.

As each subsequent application went through the wringer, regardless that each device was based on the same underlying digital technology as the one before, hundreds of far more complex machines, some representing new generations of technology in CT, MR and ultrasound, skated through the 510(k) process. The irony has not been lost on the FDA, which four years ago announced its intent to downgrade FFDM systems to Class II.

In May 2006, the FDA publicly discussed plans to reclassify FFD mammography systems from Class III to Class II. Two years later the agency released for public comment a draft guidance describing the proposed reclassification. A public meeting followed in November 2009 during which the draft guidance was discussed. Yesterday, Nov.4, the FDA made the reclassification official.

In a statement befitting the caution exercised by this country’s regulatory watchdog, the FDA noted that digital mammography systems had been categorized as “high risk” devices for more than a decade. But since their first issue, digital mammography has been well-validated in scientific studies involving tens of thousands of patients, according to the FDA, and they now can be reclassified from Class III to Class II – medium risk devices.

Over the 11 years in which FFDMs were governed by the PMA process, a dozen FFDM devices made it through. Several were brand new, requiring full review. The rest were iterative improvements, requiring an abbreviated process called supplemental PMA.

The last of the new devices approved under the PMA system was Carestream’s FFDM computed radiography system. Coincidentally Carestream Health chose the same day to announce its approval as the FDA did to announce the downgrade the regulatory process governing these devices.

(Once the FDA approves the final product labeling, Carestream can begin commercially distributing its CR mammography product, as well as upgrading existing CR units in the field to mammo capability. A simple software upgrade and special mammo compatible phosphor plates are all that will be needed.)

FFDM products from this point on can look forward to a much simpler review. To ease the transition to this new process, the FDA released a special controls guidance for industry that describes what evidence will be needed to show substantial equivalence for these systems, including technical device specifications, images of standard test objects, and a sample set of patient images.