In addition, the design control requirements (21 CFR 820.30) of the Quality System regulation should be reviewed as well. We recommend that device-specific guidance documents be consulted at the device planning stage. These documents are available through the Guidance Documents page.ĭevice-specific guidance documents may describe in detail the information for inclusion in the 510(k) submission to facilitate the FDA's review for that particular type of device. The FDA issues guidance documents to communicate the Agency's recommendations to industry. Guidance Documentsįor more information on the regulatory framework, policies, and practices underlying the FDA's 510(k) review for Abbreviated 510(k)s, please refer to the guidance The Abbreviated 510(k) Program. Manufacturers should be aware that, in most cases, additional information will be necessary for converted documents. If the 510(k) is converted, the original receipt date remains as the start of the review period. If the FDA determines that an Abbreviated 510(k) is not appropriate for review as submitted, the FDA will notify the submitter of this decision and convert the 510(k) to a Traditional 510(k). In an Abbreviated 510(k) submission, manufacturers provide summary reports based on the use of guidance documents and/or special controls, or declarations of conformity to recognized standards, to facilitate the FDA's review of a submission. Demonstration of compliance with special controls for the device type, or.Under certain conditions, you may not need to submit test data in an Abbreviated 510(k).ĭevice manufacturers may choose to submit an Abbreviated 510(k) when the submission relies on: An Abbreviated 510(k) submission must include the required elements identified in 21 CFR 807.87 (Information required in a premarket notification submission). The Abbreviated 510(k) relies on the use of guidance documents, special controls, and voluntary consensus standards. The Special 510(k) and Abbreviated 510(k) submission types can be used when a 510(k) submission meets certain factors. In 2019, the FDA split The New 510(k) Paradigm into two distinct guidance documents: The Special 510(k) Program and The Abbreviated 510(k) Program. These Programs were previously described in the New 510(k) Paradigm guidance. In 1998, the FDA developed both the Special and Abbreviated 510(k) Programs to facilitate the review of certain types of submissions subject to 510(k) requirements. There are three types of Premarket Notification 510(k)s that may be submitted to the FDA: Traditional, Special, and Abbreviated. Content and Format of an Abbreviated 510(k).
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |