Key points from the CDRH and FDA draft guidance under 21 CFR part 11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the Center for Devices and Radiological Health (CDRH) of the US Food and Drug Administration (FDA or Agency) issued a draft guidance document titled “Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11 – Questions and Answers”.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Some key points from the draft guidance include:

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How can medical device makers assess the FDA implications of 3D printing?

Adhering to FDA regulations on the manufacture of medical devices might be simpler when it’s more complicated.

That is to say: When manufacturers work in the traditional mode of large-scale, industrial production, they know the rules and are prepared to work under them. But what about when the manufacturing process becomes simpler – as in the case of 3D printing? How do the rules apply to that new frontier?

3D printing, or additive manufacturing (AM), offers device makers a range of potential advantages. They can be more innovative in design, address needs in a more customized way, and deliver products directly at the point of use. AM opens the door to offerings that would previously have been cost-inefficient because of scale.

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21st Century Cures Act (H.R. 6)

The 21st Century Cures Act (“the Act”) is intended to address a significant number of current challenges within the industry including reduction of barriers to research collaboration, incorporation of the patient perspective into the drug development and regulatory review process, earlier identification of diseases through personalized medicine, modernization of clinical trials, and the elimination of regulatory uncertainty for the development of new medical applications. It also includes provisions to incentivize the development of drugs for rare diseases, invest in science and the next generation of investigators, and support the biomedical ecosystem to accelerate discovery of new cures.

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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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