Key points from the CDRH and FDA draft guidance under 21 CFR part 11

In June 2017, the Center for Devices and Radiological Health (CDRH) of the US Food and Drug Administration (FDA or Agency) issued a draft guidance document titled “Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11 – Questions and Answers”.  While focused on the use of electronic records and signatures for clinical trial documents, the concepts and requirements outlined in the guidance reflect the Agency’s latest thinking on this topic and should be considered when implementing electronic records and signatures across the medical product lifecycle.  At 28 pages, the document has a lot of content in keeping with FDA’s current policy of providing guidance documents that include more practical examples to help industry comply with the requirements.

Some key points from the draft guidance include:

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FDA issues draft technical guidance for additive manufactured devices

How can quality systems evolve to realize the potential of 3D printed medical devices?

3D printer

The US Food and Drug Administration (FDA) has released a new draft guidance for medical device manufacturers working with additive manufacturing (AM), also known as 3-dimensional printing (3DP). AM is a process of joining materials to make objects from 3D model data, usually layer upon layer, as opposed to subtractive manufacturing methodologies 1. “The process begins with a 3D model of the object, usually created by computer-aided design (CAD) software or a scan of an existing product.  Specialized software slices this model into cross-sectional layers, creating a computer file that is sent to the AM machine.  The AM machine then creates the object by adding layers of material on top of each other until the physical object is created.

Companies pursuing AM capabilities choose between divergent paths (figure below):

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Quality System Maturity Model for Medical Devices

Assessing quality system maturity models that could help medical device companies drive quality beyond compliance

US Supreme Court building

Posted by George Serafin, National Managing Director, Life Sciences & Healthcare on July 28, 2015.

Deloitte Advisory recently collaborated with the Medical Device Innovation Consortium (MDIC) to conduct research sponsored by the Food and Drug Administration (FDA) into quality system maturity models that other industries are using. MDIC is a public-private partnership collaborating on regulatory science to make patient access to new medical device technologies faster, safer, and more cost-efficient.

While there are already explicit regulations globally for medical devices and diagnostics, the industry does not yet have a widely recognized maturity model for quality management systems (QMS). The objective of this project was to recommend specific maturity model options that could be adopted by MDIC stakeholders, including medical device industry members and the FDA.1


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Hot Off the Press: FDA Strategic Priorities

Hot Off the Press: FDA Strategic PrioritiesPosted by Seth Whitelaw, Director, Deloitte & Touche LLP

Just before the July 4,2014, the U.S. Food and Drug Administration (FDA) released a draft of its strategic priorities for the next four years. In case you were busy celebrating the holiday and didn’t have a chance to read through all forty pages of the report, here is a quick recap of some of the goals the FDA will be focusing on between now and 2018. The FDA’s updated goals align closely with the trends we highlighted in our recent mid-year overview of the regulatory environment in life sciences, which looks at these issues in more detail.

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Preparing for FDA Social Media Guideline Implementation

Preparing for FDA Social Media Guideline Implementation

The FDA has released new guidance regarding utilization of social media for advertising and promotion of pharmaceuticals and medical devices. This long-awaited guidance is the start of numerous specific guidance documents addressing defined issues in social media.

As companies search for new and effective ways to reach healthcare professionals through non-personal channels, the emergence of short-form media options is increasingly becoming a meaningful marketing and information dissemination platform. However, the legal, regulatory and safety professionals need to begin conversations with the commercial and marketing teams to take full advantage of the new communication channels, while remaining compliant. Effective processes and controls will need to be put into place to enable companies to leverage these platforms; and, in order to use these platforms, companies will need to have modified review and approval pathways to facilitate expedited approvals to keep pace with the speed of social media posting.

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