<?xml version="1.0" encoding="UTF-8"?><rss version="2.0"><channel><title>GxPlex — US regulatory status changes</title><description>Recorded changes to the published status of tracked US instruments. Reports status only; no advice or interpretation.</description><link>https://gxplex.com/</link><language>en</language><item><title>NIST CSF 2.0: status change</title><link>https://gxplex.com/instrument/nist-csf/</link><guid isPermaLink="true">https://gxplex.com/instrument/nist-csf/</guid><description>unknown → final. status recorded as final (previously unknown). Source: https://nvlpubs.nist.gov/nistpubs/CSWP/NIST.CSWP.29.pdf</description><pubDate>Sat, 01 Aug 2026 00:00:00 GMT</pubDate></item><item><title>FDA AI guidance: status change</title><link>https://gxplex.com/instrument/fda-ai-guidance/</link><guid isPermaLink="true">https://gxplex.com/instrument/fda-ai-guidance/</guid><description>correction: status withdrawn — the Federal Register announces this guidance as a draft Source: https://www.federalregister.gov/documents/2025/01/07/2024-31542/considerations-for-the-use-of-artificial-intelligence-to-support-regulatory-decision-making-for-drug</description><pubDate>Thu, 30 Jul 2026 00:00:00 GMT</pubDate></item><item><title>FDA AI guidance: status change</title><link>https://gxplex.com/instrument/fda-ai-guidance/</link><guid isPermaLink="true">https://gxplex.com/instrument/fda-ai-guidance/</guid><description>final → unknown. correction — `final` was read from FDA&apos;s search-page help text; the entry also pointed at the search page rather than at the guidance Source: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/considerations-use-artificial-intelligence-support-regulatory-decision-making-drug-and-biological</description><pubDate>Thu, 30 Jul 2026 00:00:00 GMT</pubDate></item><item><title>FDA guidance agenda: status change</title><link>https://gxplex.com/instrument/fda-guidance-agenda/</link><guid isPermaLink="true">https://gxplex.com/instrument/fda-guidance-agenda/</guid><description>draft → unknown. correction — `draft` was read from a sentence about the guidances the agenda lists, not about the agenda; an agenda has no status Source: https://www.fda.gov/drugs/guidances-drugs/cder-guidance-agenda</description><pubDate>Thu, 30 Jul 2026 00:00:00 GMT</pubDate></item><item><title>FDA CDRH AI/ML: date change</title><link>https://gxplex.com/instrument/fda-cdrh-aiml/</link><guid isPermaLink="true">https://gxplex.com/instrument/fda-cdrh-aiml/</guid><description>resolving → error page. correction: primary source URL no longer resolves Source: https://www.fda.gov/medical-devices/software-medical-device-samd</description><pubDate>Wed, 29 Jul 2026 00:00:00 GMT</pubDate></item><item><title>FDA CSA: date change</title><link>https://gxplex.com/instrument/fda-csa/</link><guid isPermaLink="true">https://gxplex.com/instrument/fda-csa/</guid><description>resolving → error page. correction: primary source URL no longer resolves Source: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/computer-software-assurance-production-and-quality-system-software</description><pubDate>Wed, 29 Jul 2026 00:00:00 GMT</pubDate></item><item><title>FDA guidance agenda: date change</title><link>https://gxplex.com/instrument/fda-guidance-agenda/</link><guid isPermaLink="true">https://gxplex.com/instrument/fda-guidance-agenda/</guid><description>resolving → error page. correction: primary source URL no longer resolves Source: https://www.fda.gov/drugs/guidances-drugs/guidance-agenda-new-and-revised-draft-guidances-cder-plans-publish-during-calendar-year</description><pubDate>Wed, 29 Jul 2026 00:00:00 GMT</pubDate></item><item><title>FDA AI guidance: status change</title><link>https://gxplex.com/instrument/fda-ai-guidance/</link><guid isPermaLink="true">https://gxplex.com/instrument/fda-ai-guidance/</guid><description>unknown → final. status recorded as final (previously unknown). Source: https://www.fda.gov/regulatory-information/search-fda-guidance-documents</description><pubDate>Tue, 28 Jul 2026 00:00:00 GMT</pubDate></item><item><title>FDA data integrity: status change</title><link>https://gxplex.com/instrument/fda-data-integrity/</link><guid isPermaLink="true">https://gxplex.com/instrument/fda-data-integrity/</guid><description>unknown → final. status recorded as final (previously unknown). Source: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/data-integrity-and-compliance-drug-cgmp-questions-and-answers</description><pubDate>Tue, 28 Jul 2026 00:00:00 GMT</pubDate></item><item><title>FDA PCCP: status change</title><link>https://gxplex.com/instrument/fda-pccp/</link><guid isPermaLink="true">https://gxplex.com/instrument/fda-pccp/</guid><description>unknown → final. status recorded as final (previously unknown). Source: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence</description><pubDate>Tue, 28 Jul 2026 00:00:00 GMT</pubDate></item><item><title>21 CFR Part 11: status change</title><link>https://gxplex.com/instrument/us-21-cfr-part-11/</link><guid isPermaLink="true">https://gxplex.com/instrument/us-21-cfr-part-11/</guid><description>unknown → final. status recorded as final (previously unknown). Source: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-11</description><pubDate>Tue, 28 Jul 2026 00:00:00 GMT</pubDate></item></channel></rss>