Pharma GMP News of the Week: 2-October-2022

Period: September 25, 2022 to October 1, 2022

India publishes proposed regulations for registering Class A medical devices that are neither sterile or measuring

Date of news: September 20, 2022

The draught revisions to the medical device rules have been made available for comment by the Indian Ministry of Health and Family Welfare. A new section on the registration of “Class A (non-sterile and/or non-measuring) medical equipment” is anticipated by officials.

Manufacturers of medical devices covered by the new chapter are required by regulations to register their goods by submitting data to an internet site. The initial plan outlines the specifics of each gadget, such as its intended usage, that makers and importers will need to input.

Source: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=OTA0MQ== 

FDA published draft guidance on “Ethical Considerations for Clinical Investigations of Medical Products Involving Children”

Date of news: September 26, 2022

Clinical studies in children are critical for gaining data on the safety and effectiveness of medications, biological products, and medical devices in children, as well as protecting children from the dangers associated with exposure to potentially hazardous or ineffective medical goods. Children are a vulnerable demographic that cannot agree for themselves and hence require additional measures while participating in a clinical trial. Such precautions are a must for the start and continuation of paediatric research as part of a medical product development programme. The FDA’s current thinking on ethical issues for clinical trials of medicinal goods in children is described in this advice.

Source: https://www.fda.gov/media/161740/download 

FDA published draft guidance on “Providing Over-the-Counter Monograph Submissions in Electronic Format”

Date of news: September 27, 2022

The Food and Drug Administration (FDA or Agency) has made a draft advice for industry titled “Providing Over-the-Counter Monograph Submissions in Electronic Format” available. This advice explains how to submit electronic submissions to the FDA under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Source: https://www.fda.gov/media/161822/download 

MHRA has updated Good clinical practice for clinical trials

Date of news: September 27, 2022

Source: https://www.gov.uk/guidance/good-clinical-practice-for-clinical-trials#full-publication-update-history 

FDA published final guidance on “Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data in Premarket Notification (510(k)) Submissions”

Date of news: September 28, 2022

The FDA’s guidelines on clinical performance assessments to support premarket notification (510(k)) submissions for computer-assisted detection (CADe) devices applied to radiography pictures and radiology device data are provided in this guidance paper. This recommendation applies to CADe devices, including the detection aspect of combined computer-aided detection and diagnostic equipment. The guidelines are meant to increase uniformity and speed up the consideration of clinical performance assessments in CADe 510(k) applications.

Source: https://www.fda.gov/media/77642/download 

FDA published final guidance on “Clinical Decision Support Software”

Date of news: September 28, 2022

The final advice underscores that the FDA’s existing digital health standards continue to apply to software functionalities that fit the definition of a device, including those used by patients or caregivers. The final guidance also includes examples of how the FDA implements the Non-Device CDS criterion. These examples distinguish between Non-Device CDS functions that satisfy all four requirements and device functions that do not satisfy one or more of the criteria.

Source: https://www.fda.gov/media/109618/download 

FDA published final guidance on “Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data – Premarket Notification [510(k)] Submissions”

Date of news: September 28, 2022

This document contains the FDA’s guidelines for premarket notification (510(k)) submissions for computer-assisted detection (CADe) devices used on radiological pictures and radiography device data. This advise applies to all CADe devices, including those sold as a full package with a review workstation, as add-on software incorporated into imaging equipment, as an image review platform, or as other imaging accessory equipment. The guidelines are designed to encourage uniformity and make 510(k) submissions for CADe devices more efficient.

Source: https://www.fda.gov/media/77635/download 

FDA published final guidance on “Display Devices for Diagnostic Radiology”

Date of news: September 28, 2022

This paper contains the FDA’s recommendations for premarket notification (510(k)) submissions for display devices used in diagnostic radiology. This advise relates to diagnostic radiological display devices as defined by their categorization rule (21 CFR 892.2050) and product numbers. This covers diagnostic radiological display equipment such as soft-copy displays and medical grade monitors. The suggestions are meant to encourage uniformity and make it easier to examine display devices.

Source: https://www.fda.gov/media/95527/download 

FDA published final guidance on “Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices”

Date of news: September 28, 2022

Following the issue of the final rule, “Medical Devices; Medical Device Classification Regulations to Conform to Medical Software Provisions in the 21st Century Cures Act,” this guideline was altered through a minor modification to reflect amended medical device classification regulations (86 FR 20278).

Source: https://www.fda.gov/media/88572/download 

FDA published final guidance on “Policy for Device Software Functions and Mobile Medical Applications”

Date of news: September 28, 2022

This guideline was changed with a minor modification to accommodate amended medical device categorization requirements as a result of the final rule, “abcMedical Devices; Medical Device Classification Regulations To Conform to Medical Software Provisions in the 21st Century Cures Act” (86 FR 20278), as well as to update information impacted by the final guidance, “Clinical Decision Support Software.”

Source: https://www.fda.gov/media/80958/download 

The MHRA has appointed the first new UK Approved Body to certify medical devices since Brexit.

Date of news: September 29, 2022

In order to guarantee that only safe and effective medical devices are distributed to UK consumers, the Medicines and Healthcare Products Regulatory Agency (MHRA) has certified that DEKRA Certification UK Ltd. has now joined the three other UK Approved Bodies.

Any possible organisation must now go through the new designation procedure in order to be permitted to certify medical devices in the UK, and DEKRA has become the first organisation to do it. They are now recognised as an organisation authorised by the UK to conduct evaluations of general medical equipment (known as Part II designation).

Source: https://www.gov.uk/government/news/mhra-appoints-first-new-uk-approved-body-to-certify-medical-devices-since-brexit 

DG SANTE of the European Commission joins the list of PIC/S Associated Partner Organizations

Date of news: September 29, 2022

Geneva, September 29, 2022 The Directorate-General for Health and Food Safety of the European Commission has been given the status of Associated Partner Organization by the PIC/S Committee (DG SANTE).

Source: https://picscheme.org/en/news 

News from MHRA – The European Commission Decision Reliance Procedure (ECDRP) is still in effect till December 31, 2023.

Date of news: September 30, 2022

To ensure that British citizens continue to have prompt access to medications while MHRA develops recommendations for a new international reliance framework, the European Commission Decision Reliance Procedure has been extended by 12 months to apply across Great Britain until 31 December 2023.

Source: https://www.gov.uk/government/news/european-commission-decision-reliance-procedure-ec-drp-extension 

News from EMA – Fees for pharmacovigilance applications that will be adjusted as of October 3, 2022

Date of news: September 30, 2022

As on October 3, 2022, the pharmacovigilance costs that applicants and holders of marketing authorizations must pay to the European Medicines Agency will increase by 5.6% to account for inflation rate increases of 0.3% in 2020 and 5.3% in 2021.

All applications will be assessed the existing fee and reduction rates if they are submitted by or have a data lock point (DLP) of October 3, 2022. After that date, the revised charges will be applied to any applications or DLPs.

Source: https://www.ema.europa.eu/en/news/regulatory-information-adjusted-fees-pharmacovigilance-applications-3-october-2022

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