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# No Evidence of Predicate Device Age Value: Comment
- URL: https://www.fdaweb.com/no-evidence-of-predicate-device-age-value-comment/
- Published: 2019-05-22T12:00:00.000Z
- Updated: 2026-09-15T01:28:22.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5144164

Johnson & Johnson says that an FDA proposal to post a list of devices relying on predicates older than a specified number of years is “built on a lack of evidence that age of predicate is a substantial indicator of medical device innovation.” Commenting on agency proposals to modernize the 510(k) program, J&J [says](https://www.regulations.gov/document?D=FDA-2018-N-4751-0049&ref=fdaweb.com) publication of such a list could be confusing to the public and could lead to an inference that medical devices that rely on older predicates may not be safe and effective.

The company also says it is important that any information on the regulatory clearance pathway of safe and effective medical devices be accompanied by educational materials that provide appropriate context do inaccurate conclusions are not drawn from the information.

In its [letter](https://www.regulations.gov/document?D=FDA-2018-N-4751-0050&ref=fdaweb.com), the Medical Imaging & Technology Alliance says that **(1)** changes to the 510(k) pathway should have clear benefits to patients and innovators; **(2)** FDA should ensure that new pre-market review pathways align with already existing programs and are in line with established commitments; **(3)** FDA should not implement arbitrary restrictions on predicate devices; and **(4)** the safety and performance standards ecosystem for medical imaging devices is sufficiently robust to support a new review paradigm.