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FDA Releases Final Guidance on Use of Digital Health Technologies for Remote Data Acquisition in Clinical Investigations

FDA Law

Baumhardt, Senior Medical Device Regulation Expert — As an end of the year gift, FDA finalized its guidance document, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations , in late December. The guidance addresses the use of DHTs in clinical investigations of drugs, biologics, and medical devices.

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Are Predetermined Change Control Plans on the road to Global Harmonization?

FDA Law

See our prior blog post on the topic here. Risk-based This guiding principle ensures risk management principles are used to evaluate the individual and cumulative changes over the life of the device. If the change does not meet specified performance criteria, it will not be implemented under the PCCP.

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Ninth Circuit Upholds FDA’s Authority to Regulate Stem Cell Clinic Treatments

FDA Law

The District Court in this case, which came to the opposite conclusion and is now reversed, was a notable outlier in a string of cases in other circuits upholding FDA’s authority to regulate stem cell clinics on similar grounds as the Ninth Circuit did here. Stem Cell Clinic, LLC , 998 F.3d Regenerative Sciences, LLC , 741 F.3d

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Change is Inevitable – Plan Ahead: An Assessment of FDA’s Draft Guidance on Predetermined Change Control Plans for Artificial Intelligence/Machine Learning-Enabled Device Software Functions

FDA Law

Manufacturers should be able to verify and validate the proposed modifications within their existing quality system. Post-market, manufacturers can make modifications consistent with the PCCP and document the modification in accordance with their quality system, without the need for a new marketing submission.

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A Question 30 Years in the Making: Would a Final LDT Rule Withstand Judicial Scrutiny?

FDA Law

Regulating LDTs: A Long and Winding Road In what might sound to some like protesting too much, the PR invokes FDA’s longstanding assertion that IVDs “manufactured” by laboratories are medical devices and that clinical laboratories that develop tests are acting as manufacturers.

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COVID At-Home Antigen Tests: If at First You Don’t Succeed Try, Try and Try Again

FDA Law

The 80% sensitivity requirement for antigen tests has yet to be explained either scientifically or clinically by the Agency. The study represents the most robust attempt at understanding the performance of serial use of rapid antigen tests for SARS-CoV-2 detection among asymptomatic individuals in the U.S.

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eMDR System Enhancements

FDA Law

Manufacturers who submit reports via the FDA Electronic Submissions Gateway are being advised to update their systems by this time. Background FDA first introduced the final rule and guidance on eMDR in 2014 , which we blogged about here. User facilities are not required, but have been encouraged, to submit MDRs electronically.