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# ISPE Wants Longer Device Quality System Implementation
- URL: https://www.fdaweb.com/ispe-wants-longer-device-quality-system-implementation/
- Published: 2022-05-19T12:00:00.000Z
- Updated: 2026-09-14T17:45:14.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5151853

The International Society for Pharmaceutical Engineering (ISPE) says FDA should provide an implementation time of at least three years for a revised medical device Quality Management System regulation. In its comment [letter](https://www.regulations.gov/comment/FDA-2021-N-0507-0047?ref=fdaweb.com), ISPE also says FDA should state that any standards referenced refer to the current FDA recognized version of the standard and any reference in the draft to a standard version should be removed.

In its [comment](https://www.regulations.gov/comment/FDA-2021-N-0507-0046?ref=fdaweb.com), ZimVie says there are many benefits in the proposal such that it will stimulate other countries to follow the same approach, which will benefit industries that deal with multiple countries and markets.

Philips Healthcare [says](https://www.regulations.gov/comment/FDA-2021-N-0507-0048?ref=fdaweb.com) it strongly supports transition of the current FDA quality system regulation to the proposed quality management system regulation through incorporation of the International Standardization Organization Quality Management System for Medical Devices. “We applaud FDA in their approach. By proposing the use of this international consensus standard without modification it provides an excellent example to the global community,” Philips says. The company says it also supports the industry position that there should be a two-year implementation period rather than the one year proposed by FDA.

Each letter also contains specific comments and recommendations.