Today the U.S. Food and Drug Administration (FDA) is issuing a proposed order to exempt certain class II flow cytometry instruments from premarket notification(510(k)) requirements, subject to limitations and conditions. The FDA will continue to review the relevant functionality of these devices when they are used clinically with an in vitro diagnostic device (IVD) reagent or test kit that is subject to FDA premarket review.
The proposed exemption applies only to cytometry instruments used for counting or characterizing cells , which use well-understood and mature technology.
The intent of this proposed order is to:
- Reduce the regulatory burden by providing a more streamlined and efficient process to bring these instruments to market
- Make flow cytometry instruments used to count or characterize cells more accessible to health care providers.
Limitations and Conditions
In the proposed order, the FDA is establishing limitations and conditions on the exemption to provide a reasonable assurance of safety and effectiveness for certain flow cytometry instruments. To be considered exempt from premarket review, the performance of the instrument must be demonstrated with either fluorescent beads or detection materials coupled with fresh, fixed, or stabilized cells that have been cleared, approved, or exempted from the premarket notification requirement. The FDA believes these limitations along withgeneral controls for medical devices will ensure the cytometry instruments remain safe and effective.
Cytometry instruments used for sorting or collecting cells and instruments that are used as an automated hematology analyzer or that perform automated differential cell counts will still require premarket notification (510(k)) clearance.
Submit Comments on the Proposed Order
We welcome your comments and suggestions regarding this proposed order. The comment period will be open until May 5, 2019 in the Federal Register under docket number 2019-03967.
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