Devices

Third-Party Review Guidance

FDA has published a guidance, 510(k) Third-Party Review Program and Third-Party Emergency Use Authorization (EUA) Review, with information on the two programs. The document says the guidance’s objectives are to:

describe and distinguish FDA’s expectations for the 3P510k review program and 3PEUA review;
the factors FDA will use in determining device type eligibility for review by 3P510 ROs (review organizations);
outline FDA’s process for the recognition, re-recognition, suspension, and withdrawal of recognition for 3P510k ROs;
clarify FDA’s expectations for review under both 3P510k review and 3PEUA review for all stakeholders to ensure confidence and consistent quality of work by third-party review organizations to eliminate the need for routine, substantive re-review by FDA;
outline FDA’s expectations to prevent conflicts of interest between the third-party review organization(s) and other entities; and
describe FDA’s expectations regarding the compensation process between the third-party review organization(s) and other entities.

The guidance contains an Introduction, Background, Scope, Definitions, Third-Party Review of 510(k) Submissions and EUA Requests, and the Paperwork Reduction Act of 1995.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome