RA/QA News Roll: Late August 2023

Here's what's happening at FDA and across the broader life science RA/QA space.

This is our biweekly recap of news and industry happenings curated for our paid subscribers. Our goal is to bring you the headline news as well as the stories, research, and insights that might be harder to find.

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Here are some key items from the past couple of weeks.

FDA Guidances

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• The FDA has introduced a Level 2 (procedural) amendment to its guidance document on Off-the-Shelf (OTS) software in medical devices. This updated guidance clarifies the information the FDA expects to see concerning OTS software integrated into medical devices. This revision is in line with the June 2023 Pre-market Submissions guidance for software products, which became effective on August 13th. As a result, all submissions involving software-containing devices are now required to adhere to the updated document format specified therein. This means transitioning from the "three levels of concern" framework to the streamlined two-tier system of Basic and Enhanced documentation. The latest iteration of the OTS software guidance now mirrors the new Pre-Market submissions guidelines, laying out suggestions for both Basic and Enhanced documentation facets for OTS software.

• The FDA has released new guidance indicating a delay in enforcing specific elements of the Drug Supply Chain Security Act. Enforcement will now be postponed until November 27, 2024. This extension aims to provide companies with extra time to further develop and enhance systems and processes for electronic data exchange.

• While not an FDA guidance, the USP has released a Technical Guidance for Pharmaceutical Continuous Manufacturing, marking the beginning of a projected series of such guides.

FDA General

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• The FDA's Office of Regulatory Affairs has launched a new "Satellite Laboratory" at the Miami International Mail Facility. This lab aims to prevent counterfeit, misbranded, and adulterated products from entering the US.

• During a recent speech at the Alliance for a Stronger FDA, FDA Commissioner Robert Califf highlighted plans to make manufacturing facility inspections “more accessible on the internet” online and easier to locate, as noted by FiercePharma's Fraiser Kansteiner. Additionally, the FDA intends to provide more information about the quality management of these facilities.

• The Pharmaceutical Inspection and Cooperation Scheme (PIC/S), a group that includes the FDA, has published a revised Annex focusing on sterile manufacturing.

• The FDA has announced a webinar on its proposed AI/ML framework, featuring Mira Jacobs, the acting assistant director for digital health policy leadership and development at the Digital Health Center of Excellence (DHCoE). Since the DHCoE's inception in 2020, Jacobs has been a part of the team as a Biomedical Engineer. Read the proposed framework here.