FDA contemplates changing approval process for software used as a medical device — 4 insights

The FDA is contemplating changing its medical device for software approval process, JD Supra reports.

Here's what you should know.

1. Software as a medical device applies to all software used to regulate medical devices. Treatment-planning software that supplies instructions to a seperate device is one example.

2. After realizing the old approval process was outdated, the FDA developed a new streamlined, approval process for these software products.

3. The FDA announced the Software Precertification Pilot Program in 2017. Included in it is a regulatory review process for software that includes:

Precertification of digital health developers, requiring appropriate patient safeguards
Avenues for precertified developers to marker lower risk devices with FDA review or through a streamlined review process
Collection of real world postmarket data to affirm the software's regulatory status

4. To establish the new precertification project, the FDA collaborated with nine pilot companies, soliciting their advice on the process.

5. JD Supra reports the FDA "appears ready to establish standards for 'organization excellence.'" Those standards would allow an organization to gain pre-certification.

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