RQM Weekly Watch #16

RQM Recap

RQM news, content recently published, and upcoming online events.

Technical Briefs

• Three Critical Aspects of Analytical Testing for Pharmaceuticals

• Key Benefits of Chemical Characterization Laboratory Services

Video and Audio Resources

RQM is continuing our educational video series on clinical trials. Clips cover three areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. All videos in the series will be able to be viewed on LinkedIn, our podcast (Apple, Spotify), and YouTube.

Videos thus far:

1. Introducing Our Educational Video Series on Clinical Trials

2. Strategy for First-in-Human Studies (1/2)

3. Strategy for First-in-Human Studies (2/2)

4. Tactics for First-in-Human Studies

5. Strategy for Global Pivotal Studies

6. Tactics for Global Pivotal Studies

7. Would you like to get reimbursed?

8. Key Aspects of Medical Device Trial Design (1/2)

[RQM Live! #80] 18 July panel and Q&A – Beyond EtO: New EPA Regulations and Sterilization Alternatives, featuring Jessica Dreyer and Greg Murdock

Europe

• MDCG published their latest guidance on clinical evaluations for the EU MDR 2017/745: “MDCG 2024-10 Clinical evaluation of orphan medical devices”. This latest publication provides guidance on what an orphan device is, and what this status means in terms of clinical evaluations, the clinical data and evidence used within the clinical evaluation, and considerations for conducting clinical investigations on orphan devices.

• In the UK, the Royal College of Radiologists published a policy paper regarding the future management of (and funding for) radiological equipment and services in the UK's NHS.

• BSI updated their document relating to their internal capacity and lead times, highlighting a reduction of 1 month for their orthopedic and dental teams to complete technical documentation assessments.

• BSI also announced that they had issued their 1500th certificate under the EU Medical Devices Regulation (MDR), coming 12 months after they issued 1000th certificate under the MDR.

United States and Canada

• The FDA have published final guidance relating to Lab Developed Tests in the form of “Laboratory Developed Tests: Small Entity Compliance Guide”. The FDA has published this guidance to assist small entities in complying with the requirements established in FDA regulations as they apply to IVDs, including LDTs.

• The FDA have released draft guidance covering the Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products. This guidance describes FDA’s recommendations related to the device design outputs that are essential for establishing and assessing drug delivery performance of drug delivery devices (i.e. devices or combination products intended for delivery of a human drug). Essential drug delivery output (EDDO) refers to the device drug-delivery design outputs necessary to ensure the drug delivery function. 

• Another draft guidance document from the FDA addresses Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies. Diversity Action Plans are intended to increase enrollment of participants who are members of historically underrepresented populations in clinical studies to help improve the strength and generalizability of the evidence for the intended use population. Such plans must specify “the sponsor’s goals for enrollment in [a] clinical study,” “the sponsor’s rationale for such goals”, and include “an explanation of how the sponsor intends to meet those goals.”.  This guidance is intended to assist clinical study sponsors to meet requirements for the submission of Diversity Action  Plans, and includes recommendations for the information and data to submit in investigational, marketing, and post-market change applications. 

• The subject and timing of the next Medical Device Sterilization Town Hall has been announced, where it will cover examples of submissions associated with implementing a change in sterilization method.

• The FDA’s CDRH announced a partnership with the Bill and Melinda Gates Foundation to create new analytical methods to help the development of breath-based diagnostic devices for disease detection in underserved populations.

Rest of World

• The IMDRF released a draft for consultation covering their guiding principles for Good machine learning practice for medical device development. The closing date for any comments is Friday, 30th August 2024.

• The IMDRF also published updated editions (#4) of the Table of Contents (ToC) guidance for both medical devices (non-IVDs) and in vitro diagnostic devices.

• TGA have published an overview of the changes that have been made to the Australian regulations, including changes to conformity assessment evidence requirements, new reliance pathway for class III devices and new requirement for class III applications.

Recalls, FSCAs & Alerts

Class I Recall (US)

• Left Ventricular Assist System (LVAS) Monitor Correction: Abbott Medical Issues Correction for HeartMate LVAS System Monitor due to Screen Issues that May Cause Unintentional Pump Stop

• Continuous Ventilator Correction: Philips Respironics, Inc. Updates Use Instructions for OmniLab Advanced (OLA ) Ventilator due to Interruptions and/or Loss of Therapy

• Continuous Ventilator Correction: Philips Respironics, Inc. Updates Use Instructions for BiPAP V30, BiPAP A30, BiPAP A40 Due to Interruptions and/or Loss of Therapy

• Ventilator Correction: ZOLL Medical Corporation Updates Use Instructions For 731 Ventilators Due to Missing MRI Safety Information in The Labeling That May Lead to Misuse and Ventilator Failure

FDA Safety Communications

• None to report this week.

Other FSCAs / Safety Notices

• FSNs published in the UK: Field Safety Notices: 17 to 21 June 2024

In the News

• Philips BiPAP recall now linked to 65 deaths, 952 injuries

• Cardinal Health recalls procedure kits over plastic syringes made in China

Warning Letters (US)

• ​​​​​​None to report this week.  

Approvals and Clearances

• LIAISON Biotrin Parvovirus B19 IgG Plus, LIAISON Biotrin Control Parvovirus B19 IgG Plus - P220034 (DiaSorin Inc.)

• TriClip G4 System - P230007 (Abbott Medical)

• INTELLANAV STABLEPOINT Ablation Catheter & Force Sensing System on The RHYTHMIA HDX Mapping System - P150005/S074 (Boston Scientific Corporation)

• FDA Permits Marketing of First Point-of-Care Hepatitis C RNA Test

Articles We Read

Europe Related

• MDCG guidance tries to reduce burden of bringing orphan devices to EU market (RAPS)

United States Related

• To Regulate or Not to Regulate Medical Device Servicing? eXchange Speakers Debate (AAMI)

• Is AI Helping or Harming Health Equity? (AAMI)

• This Is What The California Supreme Court Did With The Learned Intermediary Rule (Drug & Device Law Blog)

• No Alternative Design, No Design Defect Claim In West Virginia (Drug & Device Law Blog)

• Experts Say LDT Small-Business Compliance Guide Does Little To Persuade (MedTech Insight)

• Doctor's recommendation does not bar patient's lawsuit over device -California top court (Reuters)

• FDA issues diversity action plan draft guidance (RAPS)

• FDA publishes LDT rule ‘CliffsNotes’ in guidance for small companies (RAPS)

• PreSTAR: a New Template for Pre Submissions and 513(g) Requests for Information (FDA Law Blog)

Stay In the Know

• Subscribe to the RQM Device Advice podcast (Apple, Spotify)

• Visit the RQM Knowledge Center for upcoming and on-demand content

• Subscribe to the RQM YouTube channel

• Follow RQM on LinkedIn for regular updates