Food and Drug Administration Safety and Innovation Act

News & Analysis as of

FDA Final Rule Mandates Drug Manufacturer Notification of Impending Drug Shortages

On July 8, 2015, the federal Food and Drug Administration (FDA) published a final rule requiring drug manufacturers to report to the Agency any supply chain disruptions that could lead to drug shortages. The final rule...more

Washington Healthcare Update

This Week: 21st Century Cures Legislation Passes House in Bipartisan Vote... CMS Releases Proposed CY 2016 Home Health Prospective Pay Rule... CMS Releases Final CY 2016 Hospital Outpatient Prospective Payment System (OPPS)...more

FDA launches medical device database: AccessGUDID

On May 4, 2015, the FDA launched the most recent component of its “Unique Device Identification System,” or “UDI System,” first created in September of 2013 and required by the Food and Drug Administration Safety and...more

FDA Makes More Electronic Submissions Mandatory

In recent months, the FDA has been pushing forward in its efforts to require that more information from regulated industry be submitted electronically. The move to electronic submissions should create a more efficient and...more

FDA's Evolving Policy Toward Health IT, Medical Apps, and Low Risk Devices

Between January 20 and February 9, 2015, the U.S. Food and Drug Administration (“FDA”) issued four guidances related to its policies toward low risk devices. These guidances were largely developed as an outgrowth from FDA’s...more

FDA Holds Webinar Discussing Final Guidance on Custom Device Exemptions - Restrictions Loosened but Exemption Remains Narrow

On October 14, 2014, the U.S. Food and Drug Administration (FDA or “the Agency”) held a webinar for industry to explain the guidance document, Custom Device Exemption: Guidance for Industry and Food and Drug Administration...more

Medical Device Update: FDA Issues Draft Guidance on Streamlined De Novo Classification Process

On August 14, the Food and Drug Administration (FDA) issued a draft guidance titled “De Novo Classification Process (Evaluation of Automatic Class III Designation).” The draft provides guidance on a streamlined process for...more

FDA Releases Long-Awaited LDT Regulatory Framework and Finalizes Companion Diagnostics Guidance

On July 31, 2014, the Food and Drug Administration (FDA) took several significant actions to clarify its policies regarding regulation of certain in vitro diagnostic devices (IVDs). First, FDA released its long-awaited plan...more

FDA seeking comments on Health IT report

Exchange of information in an electronic environment (health IT) has provided and continues to provide opportunities to improve the quality, safety, cost and efficiency of health care and encourage patient involvement. ...more

Regulation of Health IT: A Risk-Based Approach

The FDA will hold a public workshop on May 13-15, 2014 to discuss the long-awaited report (the “Report”) issued on April 3, 2014 by the three federal agencies charged with regulating health information technology (“health...more

FDA Releases FDASIA Health IT Report

On April 3, 2014, the Food and Drug Administration (FDA) released the FDASIA Health IT Report (Report). This Report fulfills Section 618 of the Food and Drug Administration Safety and Innovation Act (FDASIA), Public Law...more

Finally…FDASIA Health IT Regulation Report Released

The U.S. Food and Drug Administration (FDA), along with HHS’ Office of the National Coordinator for Health Information Technology (ONC) and the Federal Communications Commission (FCC, together with FDA and ONC, the...more

The FDASIA Health IT Report

On April 7, 2014, the Food and Drug Administration (FDA) released a report entitled “FDASIA Health IT Report: Proposed Strategy and Recommendations for a Risk-Based Framework” (the “Report”). The Report was mandated by...more

FDA, ONC, and FCC Issue Report on the Regulation and Oversight of Health IT Technologies

On April 3, 2014, the Food and Drug Administration (“FDA”) released its long-awaited report on a proposed framework for the regulation and oversight of health information technology (“health IT”). The report, developed in...more

FDA Report to Congress: 1997 Guidance Provides Solid Foundation for 510(k) Modification Decisions

Interested stakeholders have until June 4, 2014, to comment on the FDA's long-anticipated report to Congress that includes its Proposed Policy on the Premarket Notification Requirements for Modified Medical Devices. The FDA...more

The FDA’s Latest One-Two Punch to Combat Drug Shortages

On October 31, 2013, the U.S. Food and Drug Administration (“FDA”) unveiled its latest steps for preventing and resolving prescription drug shortages. First, the agency announced a proposed rule requiring manufacturers of...more

FDA Issues Final Guidance on Mobile Medical Apps: “De-Regulatory” Move Helps Clarify Certain Key Questions, But Leaves Others Open

On September 25, 2013, the Food and Drug Administration (FDA) issued its long-awaited final guidance on health-related software applications intended for use on mobile devices. Under the guidance, FDA will regulate only those...more

Agencies Seek Comments to Inform Future Health IT Regulation

As health information technology (HIT) advancements proliferate, so too must governing regulations. Three agencies – the Food and Drug Administration (FDA), the Office of the National Coordinator for Health Information...more

FDA Issues Final Guidance Documents on FDA’s eCopy Program for Medical Device Submissions

On December 31, 2012, FDA issued a final guidance document entitled “eCopy Program for Medical Device Submissions” (“eCopy guidance”). Section 745A(b) of the Federal Food, Drug, and Cosmetic (FDC) Act, which was added by...more

FDA to Finalize Mobile Medical App Rules Following Bill Passage

Yesterday, the Senate approved the Food and Drug Administration Safety and Innovation Act (FDASIA) which provides reauthorization for major components of the Prescription Drug User Fee Act (PDUFA) set to expire at the end of...more

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