Worldwide medical device QA/RA blog

News and commentary on regulatory changes.

As medical device quality assurance and regulatory affairs professionals, it can be challenging to stay on top of changes happening in our industry. Few people have the time to read lengthy articles these days and although many online newsletters exist, they are often packed with PR releases, ads or unrelated information. That is why we started this blog for QA/RA professionals in the medical device and IVD industry. The idea is to give you short updates on quality and regulatory topics that may be of interest to you.

FDA Publishes Changes to Premarket Review Standards

Effective March 8, the US FDA has issued modifications to the list of standards used by the agency in its premarket review process for medical devices. The FDA’s move is intended to help device manufacturers that declare conformity with nationally and internationally developed consensus standards comply with associated requirements, according to the regulator’s Federal Register notice. Changes to these standards will affect the following medical device product groups:

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FDA Plans 2011 Guidance for Mobile Medical Applications

At a US Food and Drug Administration town hall meeting held March 10 in Irving, TX, Center for Devices and Radiological Health director Dr.

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Australian TGA Responses to Public Comments on Proposed Medical Device Regulation Reforms

The TGA has published public comments to the discussion paper, Reforms in the Medical Devices Regulatory Framework.

Comment submissions came from a variety of stakeholders with varying interests, including industry, professional organizations, and consumer groups. A summary of the comments submitted can be found on the TGA website.

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FDA Clarifies Malfunction Reporting Requirements

The US Food and Drug Administration (FDA) has issued a clarification regarding medical device manufacturers’ and importers’ compliance with

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GHTF Moves to Disband

The Global Harmonization Task Force (GHTF), founded in 1992 to promote uniformity across medical device regulatory regimes, will soon cease to exist

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ISO 14155 Revisions to Substantially Impact Clinical Investigations

The International Organization for Standards (ISO) recently published a revision of its ISO 14155 rule governing clinical trials for medical devices, ISO 14155:2011, and manufacturers will have several new requirements to address in order to comply. (An overview of the revised standard is available from Excel Translations.) ISO 14155:2011 follows ISO 14155:2003 and ISO 14155:2009, European standards applied to medical device clinical investigations.

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TGA Improves Public Access to Medical Device Registry

The Therapeutic Goods Administration (TGA), Australia’s medical device and pharmaceutical regulator, has set up easier online access to its

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Evolving IVD Regulations in Europe

In Europe, a response was published to public comments on the proposed recast of Directive 98/79/EC.

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Australia TGA Clarification on IVD Audits

As previously reported, the TGA reformed IVD regulations in 2010 to align with GHTF recommendations, adopting a risk-based classification system. Under the new system, many IVDs will be subject to more rigorous controls, including random and mandatory audits. TGA has now published multiple IVD guidance documents.

The TGA has most recently issued guidance outlining several key points regarding IVD application audits (Technical File Review), including:

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