October 22, 2019

October 21, 2019

Subscribe to Latest Legal News and Analysis

FDA Issues Final Guidance on Interoperable Medical Devices

The U.S. Food and Drug Administration (FDA) finalized its recommendations on September 6, 2017 on how to secure interoperable medical devices’ interactions with other devices and information systems. The FDA’s initial guidance, drafted in January 2016, was designed to help manufacturers develop safe, secure information exchange systems in connected medical devices. The updated guidance incorporates comments received from industry, developers, and the public, and specifically recommends that all manufacturers of electronic medical devices take the following three steps:

  • Design their devices with interoperability as an objective;

  • Conduct appropriate verification, validation and risk management activities; and

  • Clearly specify the relevant functional, performance, and interface characteristics to the user.

The final guidance also clarifies what information on interoperability should be included in premarket submissions, makes recommendations “for appropriate functional, performance, and interface requirements for connected devices to avoid errors and inadequate interoperability, such as differences in units of measure,” and advises designers and manufacturers to “provide information on a product’s functional performance and interface characteristics so that those using it with other devices and systems can do so safely.”

Connected medical devices can offer patients enhanced functionality and a better user experience. They can also help to optimize health outcomes and reduce costs. However, care must be taken to assure that all relevant safety and usability concerns are addressed. The FDA’s updated guidance is geared toward helping manufacturers maximize the safety and security of connected medical devices and to ensure that operating and interface requirements are transparent.

© 2019 Keller and Heckman LLP

TRENDING LEGAL ANALYSIS


About this Author

Sheila Millar, Keller Heckman, advertising lawyer, privacy attorney
Partner

Sheila A. Millar counsels corporate and association clients on advertising, privacy, product safety, and other public policy and regulatory compliance issues.

Ms. Millar advises clients on an array of advertising and marketing issues.  She represents clients in legislative, rulemaking and self-regulatory actions, advises on claims, and assists in developing and evaluating substantiation for claims. She also has extensive experience in privacy, data security and cybersecurity matters.  She helps clients develop website and app privacy policies,...

202-434-4646
Jean-Cyril Walker, Keller Heckman, Environmental Compliance Lawyer, Renewable Fuel Standards Attorney
Partner

Jean-Cyril Walker joined Keller and Heckman in 2000. He advises clients on a wide range of environmental matters, including compliance with U.S. requirements governing the safe management and disposal of chemical and hazardous substances. Mr. Walker counsels fuel industry clients on federal and state requirements governing the development and distribution of fuels and fuel additives, including the renewable fuel standards (RFS and RFS2), and matters involving renewable fuel identification number (RIN) transactions. Mr. Walker regularly advises industry and trade association clients on matters concerning the regulation of hazardous air pollutants under the federal Clean Air Act (CAA) and state and local air pollution statutes. In this regard, Mr. Walker has advised clients on compliance with numerous MACT standards, including those governing pharmaceutical production, chemical manufacturing, can and other surface coatings, and other industrial operations. Mr. Walker has extensive experience with CARB regulations, and in particular, on complying with regulations governing emission of volatile organic compounds (VOCs) in adhesives, paints, and other industrial and consumer products. 

202-434-4181
Tracy Marshall, Keller Heckman, regulatory attorney, for-profit company lawyer
Partner

Tracy Marshall assists clients with a range of business and regulatory matters.

In the business and transactional area, Ms. Marshall advises for-profit and non-profit clients on corporate organization, operations, and governance matters, and assists clients with structuring and negotiating a variety of transactions, including purchase and sale, marketing, outsourcing, and e-commerce agreements.

In the privacy, data security, and advertising areas, she helps clients comply with privacy, data security, and consumer protection laws, including laws governing telemarketing and...

202-434-4234