Manufacturers may not always take a Total Product Life Cycle (TPLC) approach when preparing their medical device 510(k) Submissions to FDA. This could lead to disconnects down the road if the pre-market, post-market, and quality management systems are not integrated from the get go.
FDA's Center for Device and Radiological Health (CDRH) is currently undergoing structural changes so that the pre-market submissions, post-market functions, and quality management systems functions will be consolidated under the newly forming Office of Product Evaluation and Quality (OPEQ) which will essentially be a super office. The transition is said to be coming into effect by Fall of 2019.
In a speech by FDA Deputy Commissioner Anna Abram to the Galien Forum she said:
"And organizational changes are also afoot at the Center for Devices and Radiological Health where we're combining the Office of Compliance, Office of Device Evaluation, Office of Surveillance and Biometrics, and Office of In Vitro Diagnostics and Radiological Health into a new Office of Product Evaluation and Quality (OPEQ). OPEQ will be a Total Product Life Cycle, or TPLC, Office. TPLC reflects a holistic approach that takes into account all of the information and programs CDRH is responsible for, which impact the design, production, and use of medical devices and electronic products. The new configuration will eventually comprise seven different Offices of Health Technology which will be responsible for pre-market review, post-market surveillance and manufacturing quality and compliance to ensure patients have access to safe, effective and high-quality technology. There will also be offices dedicated to the medical device clinical evidence programs, and another dedicated to the medical device regulatory programs implemented within CDRH."
Additional information on the re-structuring will can be found here.
Where the rubber meets the road is how the medical device industry will need to also ensure the total product life cycle approach from inception, through development, submissions, commercialization, and post-market considerations. Some manufacturers may consider the quality management system and post market considerations as items after the fact, but this shift by FDA will require a new look at the best total product life cycle approach.