Pharma GMP News of the Week: 3-April-2023
Period: March 26, 2023 to April 1, 2023
PMDA, Japan published document on “Precautions for Cleaning and Disinfection of Gastrointestinal Endoscopes”
Month of news: March 2023
The Pharmaceuticals and Medical Devices Agency (PMDA) of Japan has issued guidelines for cleaning and disinfecting gastrointestinal endoscopes in order to limit the risk of contamination and device damage.
Concerns regarding cross-contamination while reusing gastrointestinal endoscopes and other similar devices have grown in recent years, prompting regulatory agencies and professional organisations to establish best practises for cleaning the items between usage.
The PDMA precautions are based on cases of improper cleaning. The possibility of cleaning components lingering in the endoscope tube is described in two situations. During surgery, the brush fell into the patient’s body in one occasion. To reduce that risk, the PMDA is requesting that anyone who cleans endoscopes check to see if any of the brush has broken off.
Source: https://www.pmda.go.jp/files/000251414.pdf
MHRA updated guidance on “How to register your medical devices with MHRA
Date of news: March 27, 2023
Source: Register medical devices to place on the market – GOV.UK
The EU has taken steps to give manufacturers more time to get certain medical devices certified under the EU Medical Devices Regulation (EU MDR)
Date of news: March 28, 2023
Source: Extension of CE certificates – GOV.UK
FDA published draft guideline “Orthopedic Non-Spinal Bone Plates, Screws, and Washers – Premarket Notification (510(k)) Submissions”
Date of news: March 29, 2023
The FDA has issued a new draft guideline describing what information should be included in premarket submissions for orthopaedic non-spinal bone plates, screws, and washers.
The proposed guidance is designed to clarify information in class II orthopaedic non-spinal, non-resorbable medical device 510(k) submissions, such as bone plates, screw systems, freestanding bone screws, and washers for bone fixation. The proposed guidance’s purpose is to “encourage consistency in information supplied in submissions by addressing common inadequacies relating to device description and performance testing and identifying suitable cross-cutting guidances and consensus standards.”
Source: https://www.fda.gov/media/166507/download
FDA published guideline “Cybersecurity in Medical Devices: Refuse to Accept Policy for Cyber Devices and Related Systems Under Section 524B of the FD&C Act”
Date of news: March 30, 2023
Because the Agency decided that prior public involvement is not practicable or appropriate, this guideline is being implemented without prior public comment (see section 701(h)(1)(C) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371(h)(1)(C) and 21 CFR 10.115(g)(2)). The FDA has determined that obtaining public feedback prior to the 90-day statutory limit for the implementation date of Section 524B of the FD&C Act is not possible. Although this policy is being adopted without previous notice, the FDA will review any comments received and amend the guidance paper as necessary.
Source: https://www.fda.gov/media/166614/download
FDA published guideline “Identification of Medicinal Products — Implementation and Use”
Date of news: March 30, 2023
This document provides assistance to sponsors, applicants, and registrants involved in the regulatory filing of medical product data. The advice helps to establish and apply the International Organization for Standardization (ISO) Identification of Medicinal Products (IDMP) standards for substances, terminologies, and other information used throughout the worldwide medicinal product development lifecycle. The goal of these guidelines is to improve the quality, completeness, and consistency of information sent between stakeholders in the worldwide exchange of pharmaceutical products.
Source: https://www.fda.gov/media/166736/download
News from EMA “Regulatory information – adjusted fees for applications to EMA from April 1, 2023”
Date of news: April 1, 2023
News from MHRA “New statutory fees for MHRA services introduced from 1 April 2023”
Date of news: April 1, 2023
Source: New statutory fees for MHRA services introduced from 1 April 2023 – GOV.UK
FDA published draft guideline “Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions”
Date of news: April 3, 2023
In order to protect and promote public health, the FDA is providing this draught guideline to further develop a regulatory approach specific to artificial intelligence/machine learning (AI/ML)-enabled devices in order to increase patients’ access to safe and effective AI/ML-enabled devices. This draught guidance describes a minimally invasive strategy to supporting iterative development of machine learning-enabled device software functions (ML-DSF) while maintaining their safety and effectiveness, as stated in the FDA’s 2019 AI/ML Discussion Paper and 2021 AI/ML Action Plan. The draught guidance recommends information to include in a Predetermined Change Control Plan (PCCP) that may be included in a marketing submission for ML-DSF.
The PCCP mechanism includes the anticipated ML-DSF improvements, the process for implementing and validating such modifications, and an assessment of their impact. Since the PCCP concept was introduced, there has been a lot of interest in employing it for AI/ML-enabled medical devices. The FDA continues to receive an increasing number of marketing submissions and pre-submissions for AI/ML-enabled medical devices that have the potential to have a large beneficial impact on healthcare, and the Agency expects this to continue.
Source: https://www.fda.gov/media/166704/download
News from EU “Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices”
Month of news: April 2023
The European Commission has responded to inquiries regarding “practical aspects” of legislation to extend the transition period for the Medical Device Regulation (MDR). The Commission outlines the scope of the extension and how businesses might profit from the modifications in the question-and-answer document.
The Commission answers 18 issues in the 10-page text, including whether the revised transitory period applies to custom-made devices, how to demonstrate that a legacy device benefits from the extension, and more. The concerns range from general points, such as the fact that only older devices are eligible for the prolonged transition period, to precise terms used in the legislation.
Source: https://health.ec.europa.eu/system/files/2023-03/mdr_proposal_extension-q-n-a_0.pdf
