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# MITA Raises Software Pre-Certification Issues
- URL: https://www.fdaweb.com/mita-raises-software-pre-certification-issues/
- Published: 2019-03-07T12:00:00.000Z
- Updated: 2026-09-15T01:10:47.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5143552

The Medical Imaging and Technology Alliance (MITA) says it supports development of a regulatory system that both ensures the safety and efficacy of medical devices and reflects the real-world needs of the innovators and organizations bringing the technologies to market. Commenting on the FDA software precertification pilot program, MITA [raises](https://www.regulations.gov/contentStreamer?documentId=FDA-2017-N-4301-0121&attachmentNumber=1&contentType=pdf&ref=fdaweb.com) four issues with the software precertification program working model 1.0: 

- the value of participating in the program is unclear;
- the kinds and amounts of information that the agency is requesting are inappropriate;
- there needs to be equal consideration of all kinds of companies looking to participate in the program; and
- standards will be useful to the pre-certification program, but additional clarity is needed.

Each of the issues is explored in the comment letter.