Regulatory & Guidance Documents

The U.S. Food and Drug Administration has withdrawn 47 draft guidance documents published before December 31, 2013, which were never finalized or acted on. The announcement was posted in the Federal Register, stating that this move was made to improve the efficiency and transparency of the guidance...

Medical device regulators at the FDA have issued correcting amendments to their post-market electronic Medical Device Reporting (eMDR) requirements to eliminate any disparities between those rules and their Unique Device Identification (UDI) system.

Health Canada, the Canadian medical device market regulator, is set to require all reprocessed single-use medical devices to Canadian Medical Device Regulations (CMDR) by September 1, 2015. According to MEDEC, the national association created for the Canadian medical technology...

The FDA recognizes that the progression to digital health offers the potential for better, more efficient patient care and improved health outcomes, which requires that many medical devices be interoperable with other types of medical devices and with various types of health information technology...

To strengthen the safety of medical devices, the FDA has finalized recommendations to manufacturers for managing cybersecurity risks to better protect patient health and information. On October 1, the agency issued a final guidance on the content of premarket submissions for the management of...

On August 13, The FDA issued a guidance for industry and FDA staff called “Unique Device Identification System: Small Entity Compliance Guide”. This guidance is intended primarily to provide information to the medical device industry, including small businesses, concerning FDA’s September...

The U.S. Food and Drug Administration has issued new draft guidance that would exempt certain Class I and Class II medical devices from premarket, or 510(k),submission requirements. If a device is “exempted from premarket notification,” then the FDA would allow a device that was...

Recognizing that the need for effective cybersecurity to ensure medical device functionality has become more important with the increasing use of wireless, Internet- and network-connected devices, and the frequent electronic exchange of medical device-related health information, the FDA has issued a draft...

The U.S. Food & Drug Administration (FDA) has issued the first phase of its Global Unique Device Identification Database (GUDID): Guidance for Industry on June 11, 2014. To quickly provide industry with information critical to successful use of the GUDID, the FDA is issuing the GUDID Guidance in two...

The FDA has recently issued a draft guidance titled, "Humanitarian Device Exemption (HDE): Questions and Answers." This draft guidance answers commonly asked questions about Humanitarian Use Devices (HUDs) and the Humanitarian Device Exemption (HDE) authorized under section 520(m) of the...

Today, the FDA issued its final rule on the unique device identification (UDI) system that, once implemented, will provide a consistent way to identify medical devices. The UDI system should improve the quality of information in medical device adverse events reports, which will help the FDA identify product problems more...

The FDA Center for Devices and Radiological Health, Office of Science and Engineering Laboratories, Center for Biologics Evaluation and Research issued a Guidance document on “Radio Frequency Wireless Technology in Medical Devices” containing recommendations to assist industry and...

On July 9, the FDA issued a draft guidance on manufacturers’ responsibility to report adverse effects from their products: “Medical Device Reporting for Manufacturers,” for the purpose of seeking comments. Comments and suggestions should be submitted regarding this draft...

Now that the Centers for Medicare and Medicaid Services (CMS) has published its long-awaited final rule implementing the Physician Payments Sunshine Act (Federal Register, February 8, 2013), medical device manufacturers can move forward to carry out a familiar task: complying with regulations.