February 21, 2019 - SoftwareCPR

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February 21, 2019

Feb

Non-binding Feedback from FDA

February 21, 2019Alan KusinitzNews

The FDA released a Draft Guidance titled “Nonbinding Feedback After Certain FDA Inspections of Device Establishments”, on February 19, 2019. It provides a very limited set of conditions where companies can request non-binding FDA feedback to the adequacy of planned corrective actions. The request must be submitted within 15 days of the issuance of the...

Feb

Refuse to Accept 510(k)

February 21, 2019Alan KusinitzNews

FDA issued a version of its “Refuse to Accept Policy for 510(k)s” dated 21-Feb-2019. This supersedes the prior 30-Jan-2018 version. As FDA guidance goes, this a short period of time between updates. It focuses on explaining the initial 15 day administrative completeness check, review initial questions, provision of a checklist for this administrative review which...

IEC 62304 and Emerging Standards and FDA Expectations for Medical Device and Health IT Software – Virtual

This very popular 3-day course provides a clear understanding of applying IEC 62304 standard for medical device software and much more. The course compares and contrasts 62304 with FDA expectations and discusses approaches for alignment. In addition, participants will learn of other relevant standards and technical reports pertinent to medical device software, HealthIT, medical mobile apps, and Software as a Medical Device (SaMD) products (e.g., 82304, 80002-1, 14971, 80001-2-x, 62366).

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Non-binding Feedback from FDA

Refuse to Accept 510(k)

62304 Software Training Course – February 23-25, 2021

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