Mingham Ji

Mingham Ji

Mingham Ji is an associate in the firm’s Washington, DC office, where she is a member of the Food and Drug and Anti-Corruption practice groups. Ms. Ji advises food, dietary supplement, pharmaceutical, and biotechnology companies on regulatory and compliance issues.

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FDA Finalizes Guidance on Interoperable Medical Devices

On September 6, 2017, FDA finalized a guidance document entitled “Design Considerations and Pre-Market Submission Recommendations for Interoperable Medical Devices” (“Final Guidance”).  In the Final Guidance, the agency outlines design considerations for manufacturers when developing interoperable medical devices, as well as recommendations about information to include in premarket submissions and device labeling.  Interoperability of devices … Continue Reading

FDA Finalizes General Wellness Guidance

Last week FDA finalized a guidance document entitled “General Wellness: Policy for Low Risk Devices” in which the agency sets forth an approach to not regulate “general wellness products.”  This guidance document is important to the rapidly growing market for wellness products, which includes such things as activity trackers, smart watches, mobile apps, and other … Continue Reading

Senate HELP Committee Moves Forward With Companion Legislation to 21st Century Cures

As previously covered on this blog and in our alert, the U.S. House of Representatives passed the 21st Century Cures Act (H.R. 6) in July 2015.  The U.S. Senate Committee on Health, Education, Labor, and Pensions (commonly referred to as the “HELP Committee”) has worked on companion legislation to the House bill and, since February … Continue Reading

FDA Enters Second Week of Government Shutdown

As FDA enters its second week of the federal government shutdown, almost half of the agency’s employees have been furloughed, with a skeletal team carrying out limited operations.  According to FDA’s website, these operations are limited to emergency work involving the safety of human life or the protection of property, criminal law enforcement work, and … Continue Reading

China Launches Review of Medical Device Industry

Two agencies in the Chinese government have initiated plans to review the levels of use and the pricing of medical devices marketed in China.  This news comes in the midst of several other investigations conducted by Chinese authorities into multinational corporations across a number of industries that are doing business in the country. This month, … Continue Reading

CMS Posts Responses to FAQs on Sunshine Act Compliance

With the Sunshine Act’s August 1 compliance date for data collection rapidly approaching, the Centers for Medicare and Medicaid Services (CMS) has set up a page of frequently asked questions (FAQs) on its Open Payments website.  CMS appears to be adding FAQs on a rolling basis, with the most recent round of updates loaded in … Continue Reading

FDA Releases Final Guidance on Priority Review of Premarket Submissions for Devices

On May 17, 2013, FDA issued a guidance document regarding priority review of premarket submissions for devices.  This newly released guidance supersedes the document “Expedited Review of Premarket Submissions for Devices,” which the agency issued in 2008, and incorporates changes from the Medical Device User Fee Amendments of 2012 (MDUFA III).  As part of its … Continue Reading

CDRH Releases Updated Plan to Strengthen Postmarket Surveillance of Medical Devices

On April 23rd, FDA’s Center for Devices and Radiological Health (CDRH) released a report entitled “Strengthening Our National System for Medical Device Postmarket Surveillance: Updates and Next Steps.”  This document updates the plan issued by CDRH in September 2012, which set out the agency’s initial steps to “develop and implement a comprehensive medical device postmarket … Continue Reading

China Reorganizes the State Food and Drug Administration and Appoints a New Commissioner

China’s 12th National People’s Congress has approved a plan to establish a ministry-level agency named China Food and Drug Administration (CFDA), which replaces the State Food and Drug Administration (SFDA).  The agency has started a reorganization under the leadership of a new commissioner, Mr. Zhang Yong. On March 22, 2013, SFDA replaced the sign on … Continue Reading

FDA Releases Final Guidance Relating to Humanitarian Device Exemptions (HDE)

On January 24, 2013, FDA issued its final guidance on humanitarian use device (HUD) designation requests.  In a Federal Register notice posted on the same day, the agency explained that this final guidance was published with “minor revisions” to the draft guidance “to improve clarity.” A HUD is a medical device that is intended to … Continue Reading
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