CDRH Proposes Submission Requirements of Labeling for Certain Home-Use Devices

Today, FDA’s Center for Devices and Radiological Health published a proposed rule that would require manufacturers to electronically submit the device label and package insert for Class II and Class III devices labeled for “home-use.” The propo… Read More
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FDA Publishes Draft Guidance on Dissemination of Patient-Specific Data – But Doesn’t Say Much About HIPAA

Last week, FDA’s Center for Devices and Radiological Health (CDRH) announced the availability of a Draft Guidance on “Dissemination of Patient-Specific Information from Devices by Device Manufacturers” to clarify that “manufacturers may share… Read More
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Are You Ready for Electronic MDR Reporting?

Paper medical device reports (MDR) will soon be a thing of the past. On August 14, 2015, the electronic MDR final rule goes into effect, requiring manufacturers, importers and other firms responsible for reporting to submit MDRs to the FDA electronic… Read More
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FDA Provides Another Guidance Concerning FDA’s Use of Foreign Study Data

By Mason Weeda FDA’s Center for Devices and Radiological Health (“CDRH”) and Center Biologics Evaluation and Research (“CBER”) recently published a new draft guidance entitled “Acceptance of Medical Device Clinical Data from Studies Condu… Read More
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Who Regulates the Advertising of Your App?

We have blogged and hosted numerous webinars on FDA regulation of mobile medical apps (see here, here, here, here and here); but if you are an app developer, you should be aware that FDA is not the only agency looking at your app. The Federal Trade C… Read More
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OFW Law Launches FDA DevicEd Training Initiative

OFW Law is proud to announce the launch of its FDA DevicEd Training Initiative. The initiative is devoted to providing high quality FDA regulatory training to foreign and domestic medical device companies and the advisors who assist them. Interactive… Read More
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FDA Decides Not to Actively Regulate Medical Device Data Systems, Medical Image Storage Devices, Medical Image Communication Devices and Similar Mobile Medical Apps

There is good news for certain sectors of the medical device industry. FDA has decided not to actively regulate medical device data systems (MDDS), medical image storage devices, medical image communication devices and similar mobile medical applicat… Read More
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CDRH’s 2015 Weather Forecast Predicts A Storm of Guidance Documents

Earlier this month, FDA’s Center for Devices and Radiological Health issued its FY 2015 Proposed Guidance Development and Focused Retrospective Review of Final Guidance. CDRH lists 28 guidance documents in total. The “A-list” includes both draf… Read More
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FDA/CDRH Revamps Structure of its Office of Compliance

This past Monday (November 18), the FDA Center for Devices and Radiological Health (CDRH) launched a new webpage describing the revamped structure of its Office of Compliance (OC). One of the stated goals of the reorganization is to better align OC&#… Read More
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