On November 14, lawyers from Teva Pharmaceuticals and Covington & Burling discussed digital health innovation from a medical device regulation perspective in the U.S. and the EU. The presentation by Rachel Turow, Executive Counsel – Regulatory Law, Teva Pharmaceuticals, and Grant Castle, Scott Danzis, Sarah Cowlishaw, and Christina Kuhn of Covington, covered topics such as which digital health products the FDA’s Center for Devices and Radiological Health (CDRH) regulates, how “device” is defined by the recent 21st Century Cures Act, and the relationship between medical devices and software under EU law. The group also discussed how digital health associated with pharmaceuticals may implicate regulatory considerations under FDA’s drug authorities — a topic to be more fully explored at an upcoming Covington Digital Health webinar in early 2018.

Some of the key takeaways the panel discussed are:

  • Understanding a digital health product’s intended uses and functionalities is critical to whether product will be regulated.
  • The CDRH’s approach to digital health is evolving, and CDRH has adopted a more flexible approach to digital health as compared to other product areas.
  • The FDA isn’t the only regulator to consider — other regulators such as FTC, CPSC, state AGs, and DOJ are becoming more engaged in this area.
  • Companies marketing or expecting to market products in the EU should design new software medical devices with the EU’s Medical Device Regulation in mind.

This is the second of a series of webinars Covington is offering to help companies navigate the laws, regulations, and policies that govern the evolving Digital Health sector. The webinars are aimed at:

  • Legal, regulatory, and policy teams at life sciences and technology companies involved in the development and marketing of digital health technologies
  • Legal, regulatory, and policy professionals with backgrounds in the “traditional” pharma-biotech and medical device space, who are looking to move into the digital health space

If you would like to view a recording of this one hour webinar, please contact Jordyn Pedersen at jpedersen@cov.com.

 

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Photo of Grant Castle Grant Castle

Grant Castle practices in the areas of life sciences regulatory law, with an emphasis on pharmaceutical and medical device regulation. His advice on general regulatory matters includes: adverse event and other reporting obligations, manufacturing controls, labeling and promotion, and product life cycle management.

Grant Castle practices in the areas of life sciences regulatory law, with an emphasis on pharmaceutical and medical device regulation. His advice on general regulatory matters includes: adverse event and other reporting obligations, manufacturing controls, labeling and promotion, and product life cycle management. He has also advised extensively on EC and national laws governing clinical research, data protection, and the regulatory status of borderline products. He has developed considerable expertise in coordinating regulatory projects covering jurisdictions outside of Europe, including Canada, South America, Eastern Europe, the former Soviet Union, Africa, the Near East, Japan, and Australia. His transactional work includes advice on regulatory aspects of mergers and acquisitions, licensing, and collaborative arrangements.

Photo of Sarah Cowlishaw Sarah Cowlishaw

Sarah Cowlishaw’s practice focuses on life sciences regulatory and commercial law for pharmaceutical, medical device, food, and consumer products. Her advice on general regulatory matters includes borderline determinations, food classifications, adverse event and other reporting obligations, manufacturing controls, and labeling and promotion. Ms.

Sarah Cowlishaw’s practice focuses on life sciences regulatory and commercial law for pharmaceutical, medical device, food, and consumer products. Her advice on general regulatory matters includes borderline determinations, food classifications, adverse event and other reporting obligations, manufacturing controls, and labeling and promotion. Ms. Cowlishaw also advises on regulatory aspects of corporate/commercial deals, particularly regulatory due diligence.

Photo of Scott Danzis Scott Danzis

Scott Danzis practice focuses primarily on the regulation of medical devices, but also includes regulation of drugs, biologics, and tobacco products. Mr. Danzis regularly works with companies in developing strategies for interacting with the U.S. Food and Drug Administration (FDA), including strategies for…

Scott Danzis practice focuses primarily on the regulation of medical devices, but also includes regulation of drugs, biologics, and tobacco products. Mr. Danzis regularly works with companies in developing strategies for interacting with the U.S. Food and Drug Administration (FDA), including strategies for clinical development and premarket review (including appeals and dispute resolution, when needed). He also advises on compliance with postmarket requirements, including advertising and promotion restrictions, quality system and manufacturing requirements, postmarket reporting, recalls, and enforcement actions.

Photo of Christina Kuhn Christina Kuhn

Christina Kuhn provides pharmaceutical and medical device companies advice on a variety of federal and state regulatory matters.