FDA pushing manufacturers to adopt electronic reporting
The U.S. FDA is urging device manufacturers to voluntarily adopt its electronic medical device reporting (eMDR) process before the companies are required to do so, which could be as early as next spring.
The current eMDR initiative is part of an ongoing FDA effort to reduce the crushing amount of paper documents it receives when assessing the safety of food and drug products. The agency believes eMDR program will help the Center for Devices and Radiological Health identify patterns in adverse events.
At this point, only 15 eMDRs have been filed with FDA, all by one company, said Don St. Pierre, head of FDA's Postmarket Transformation Management Group, He also noted that the agency will need more submissions to assess how the program is working.
The current eMDR initiative is part of an ongoing FDA effort to reduce the crushing amount of paper documents it receives when assessing the safety of food and drug products. The agency believes eMDR program will help the Center for Devices and Radiological Health identify patterns in adverse events.
At this point, only 15 eMDRs have been filed with FDA, all by one company, said Don St. Pierre, head of FDA's Postmarket Transformation Management Group, He also noted that the agency will need more submissions to assess how the program is working.