Benjamin Zegarelli on Food and Drug Administration (FDA)

Five Important Themes to Watch in the Reform of FDA’s Off-Label Communications Policy

As we’ve previously reported, FDA has recently been forced to reexamine its legal position and enforcement policies related to drug and device manufacturers’ off-label communications. Although the Agency has for years...more

11/21/2016 / Commercial Speech , First Amendment , Food and Drug Administration (FDA) , Manufacturers , Medical Devices , Off-Label Promotion , Pharmaceutical Industry , Prescription Drugs , Public Hearing

FDA to Study Social Media Promotion

On November 7, 2016, FDA announced in the Federal Register its plan to research methods for including risk information about pharmaceutical and medical device products in promotional Internet communications that have...more

11/15/2016 / Federal Register , Food and Drug Administration (FDA) , Medical Devices , Social Media

Medical Device Updates: U.S. Food and Drug Administration (FDA) Releases Numerous and Important Draft Guidance Documents

The summer of 2016 saw a flood of new medical device-related guidance documents coming out of FDA’s Center for Devices and Radiological Health (CDRH). Some of these draft guidance documents, such as those addressing device...more

10/24/2016 / 510(k) RTA , Draft Guidance , Food and Drug Administration (FDA) , Manufacturers , Medical Devices , Modification , Software

FDA Opens Comment Period for Harmonized SaMD Clinical Evaluation Guidance

On October 14, 2016, FDA released draft guidance entitled Software as a Medical Device (SaMD): Clinical Evaluation (the “SaMD Draft Guidance”). The draft guidance was prepared by the SaMD Working Group of the International...more

10/17/2016 / Comment Period , Draft Guidance , Food and Drug Administration (FDA) , Medical Devices , Software

Review of International Regulation of Social Media Promotions at the 2016 RAPS Conference

The Regulatory Affairs Professionals Society (RAPS) held its annual Convergence conference last week in San Jose. The event certainly illustrated RAPS’s global influence given that the attendees represented many of the...more

9/26/2016 / China , EU , Food and Drug Administration (FDA) , Life Sciences , Medical Devices , Mexico , Social Media

FDA Releases Revised Guidance on Device Modification Policy

FDA released two new draft guidances on Monday, August 8 in an attempt to help device manufacturers determine when a modification triggers the obligation to file a new 510(k) under 21 C.F.R. § 807.81(a)(3). The first draft...more

8/16/2016 / 510(k) RTA , Draft Guidance , FDASIA , Food and Drug Administration (FDA) , Manufacturers , Medical Devices , Modification , Software

FDA Adjustment to Orphan Drug Review May Indicate Increased Scrutiny of Designations

In recent years, applications for orphan drug designations have flooded into FDA at a rapid pace, and this year appears to be no exception. Orphan drug applications received by FDA rose by approximately 30% over the previous...more

7/22/2016 / Food and Drug Administration (FDA) , Orphan Drugs , Pharmaceutical Industry

FDA Extends Comment Period on Third-Party Medical Device Servicing

As an update to my post on Friday, April 22, FDA has extended the deadline for comments on third-party servicing of medical devices. According to FDA’s notice of extension, comments are now due by June 3, 2016....more

4/27/2016 / Comment Period , Food and Drug Administration (FDA) , Medical Devices , Rulemaking Process

FDA Still Seeking Manufacturer Views on Medical Device ISO Regulation

On March 4, 2016, the FDA issued notice in the Federal Register that it had opened a docket to accept comments on the agency’s proposed plan to address the refurbishing, remarketing, rebuilding, remanufacturing, and servicing...more

4/22/2016 / Comment Period , Food and Drug Administration (FDA) , ISOs , Manufacturers , Medical Devices , OEM

Benjamin Zegarelli

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