AAMI Sterilization Standards Week FDA Co-Chair Update: Transitions Spring 2017

Transcription

1 AAMI Sterilization Standards Week FDA Co-Chair Update: Transitions Spring 2017 Sharon Lappalainen Deputy Director, CDRH Standards Program Center for Devices and Radiological Health Office of the Center Director U.S. Food and Drug Administration Tel: Excellent customer service is important to us. Please take a moment to provide feedback regarding the customer service you have received:

2 Standards Transitions Intended for revisions of recognized standards Older version to be withdrawn when the transition period expires Guidance about transitions under way Stay Tuned Jinx! 2

3 Why Transition? NASA Image An 8 Planetary Alignment + Pluto occurs about every 500 years Addresses the window between the old standard and the new when those changes that affect processes need to be implemented. Addresses issues that arise when product development, testing, and review activities are not aligned with standards activity lifecycles. Addresses the gap between SDO publication and FDA recognition 3

4 Need for a Transition Intended to reduce additional testing because a newer version of the standard was published & recognized during: Product development Product testing Clinical study Product review Manufacturing changes/retools Testing Lab changes Sterilization provider changes 4

5 Where to Find a Transition In the Supplementary Information Transition Language Includes: Outgoing version, Newer version, Expiration date, FDA recognition of [the outgoing version of the consensus standard] will be superseded by recognition of [the newer version of the recognized consensus standard]. FDA will accept Declarations of Conformity, in support of premarket submissions, to [the outgoing version of the consensus standard] until [Month, Date, and Year]. After this transition period, Declarations of Conformity to [the outgoing version of the consensus standard] will not be accepted. 5

6 Changes Before & During Review Engage CDRH on the strategy for addressing the gaps between the two standard versions Focus on whether the differences affect the evaluation of safety and effectiveness. It may not be necessary to comply with all parts of the revised standard, only those parts that affect safety and effectiveness. Provide a rationale! 6

7 Transition Expiration FDA will withdraw recognition of the outdated standard Check for FR Notices Surf the FDA Recognized Consensus Standards Database often to ensure that their submissions utilize the current version of a standard. If a submission is sent to FDA after the transition period has expired, FDA expects that testing will be completed using the current FDArecognized standard. Statements declaring conformance to expired or withdrawn version of the consensus standard will not be accepted. It is expected that by the transition period expiration date, submitters will be able to meet the performance specifications of the newer FDArecognized version of the standard. 7

8 What Standards Committees Can Do Suggest whether or not a transition is needed? Suggest a Change Management Strategy? A road map between versions A impact statement Were specifications changed? Was the method changed? Were newer methods added for consideration? Was a risk/mitigation strategy implemented in the newer version? Was the new test method validated, and can that be verified? Is there an expected impact to stakeholders? Manufacturers Testing labs 8

9 What can committees do to communicate a transition need? Manufacturers and testing organizations might need a transitional period following publication of a new, amended or revised publication to make products in accordance with the new requirements and to equip themselves for conducting new or revised tests. It is the recommendation of the committee that the content of this publication be adopted for implementation nationally not earlier than (XX months). 9

10 Comments, Suggestions, Feedback, Praises, Food for Thought Send Your Take on This To: 10

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