The U.S. Food and Drug Administration is proposing to simplify the way it classifies and reclassifies medical devices, opting to do so by administrative order rather the cumbersome rulemaking process.
It published in the Federal Register the proposed changes to conform to provisions in the FDA Safety and Innovation Act (FDASIA).
"FDA is proposing these revisions to update its regulations to reflect these and other changes, and to ensure classification of devices in the lowest regulatory class consistent with the protection of the public health and the statutory scheme for device regulation," the proposed rule states.
The FDA is taking public comment on the proposed changes through June 23.
To reclassify a device under the new rules, the FDA must publish a proposed order in the Federal Register, consider submitted comments and hold a device classification panel meeting, reports Lexology.
The changes also would set up five categories of devices in class III, the most high-risk class, including:
- Devices that present known risks that cannot be controlled
- Devices for which the risk-benefit profile is unknown or unfavorable
- Devices for which a full review of manufacturing information is necessary
- Devices for which premarket review of any change affecting safety or effectiveness is necessary
- Combination products (where the primary mode of action for combination includes a drug for which a finding is required that the drug is safe and effective or a biological product for which a finding is required that it is safe, pure, and potent
Writing in the Annals of Internal Medicine, Rita Redberg and Sarah Y. Zheng of the University of California, San Francisco, argue that the process needs to be changed for making alterations on devices that already have premarket approval. Iterative development means multiple changes, which might be reconsidered one at a time without requiring the same level of evidence. While that speeds up approval, it can introduce unknown risks, according to Heartwire.
Device recalls have doubled in the past decade, according to an FDA report, while the device market has grown even faster.
Meanwhile, a coalition of influential patient groups have raised concern about the PROTECT Act, a bill that would exempt so-called "health software" and "clinical software" devices from FDA oversight.
To learn more:
- read the proposal in the Federal Register
- here's the Lexology article
- find the Heartwire story
- read the Annals of Internal Medicine piece