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Set Alert for Policy and Regulation United States

21st Century Cures Implementation: Device Provision Updates

Dozens of reforms impacting the medtech sector were signed into law Dec. 13, 2016, in the 21st Century Cures Act. Here's a breakdown of where things stand in the implementation of key provisions.

Policy Legislation FDA

Latest From United States, Policy & Regulation

Q&A: FDA Dx Reviewer's Tips For Next-Gen Sequencing Sponsors

A top reviewer in US FDA's in vitro diagnostics office offers tips to next-generation sequencing test sponsors to avoid common submission shortcomings in this interview with Medtech Insight. According to FDA's Hisani Madison, sponsors frequently fall short in providing a refined intended-use statement.

In Vitro Diagnostics Personalized Medicine

US FDA Updates Clinical Trial e-Reporting, e-Signature Guidance To Keep Up With Tech

In a draft guidance on electronic signature and record requirements for clinical trials used to submit applications across FDA product centers, the agency responds to technological advances since it last issued guidelines almost 15 years ago, while keeping its narrow enforcement of the "Part 11" rules in place.

Regulation Clinical Trials

Device Lobbyists Support Device Tax Repeal in Senate Health Bill, As Providers Remain Opposed

AdvaMed members ratcheted up pressure on members of Congress last week to permanently abolish the device tax, be it in the Senate Affordable Care Act repeal bill, or any other way they can get it. Meanwhile, medical provider groups, including the American Medical Association, American Heart Association, and the American Hospital Association, are lobbying against the Senate's bill to prevent insurance coverage losses.

Policy Legislation

US FDA Collecting Feedback On Digital Health Plan

FDA's commissioner has signaled plans to pilot a new approach to digital health oversight, but the agency cautions that it is still putting the program together based, in part, on feedback from stakeholders. More details will be released by the time a pilot program launches in the fall.

Digital Health Regulation

ACA Repeal: A Look At Device Procedure Impacts

A select group of legislators are working behind closed doors on a Senate bill to repeal the Affordable Care Act. It's not yet clear how close or far apart it will be from the House American Health Care Act, but here is a graphical look at what the AHCA might mean for device procedure volumes.

Policy Legislation

US FDA's New Game Plan For Digital Health

Commissioner Scott Gottlieb outlined his plans to implement software provisions of the 21st Century Cures Act and go much further than that in clarifying regulatory policy and piloting novel strategies to streamline the path to market for digital health technologies.

Digital Health Regulation
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Latest From United States & Quality Control

More Review-Streamliners Introduced In US House: Can They Beat User-Fee Buzzer?

Two more bills were introduced in the House this week to streamline US FDA device review. Its late in the game, but device lobbyists are not completely ruling out attachments to must-pass user-fee bills. Also, check out our table rounding up FDA medtech reform bills that are circulating in Congress.

Legislation Policy

'Your Ombuddy': ORA's New Ombudsman Doesn't Want Device Firms To Be Terrified Of Her

When you pick up the phone to contact US FDA, do you sweat? That's exactly the type of response that Jessica Zeller, the very first ombudsman for the agency's Office of Regulatory Affairs, wants to avoid. "I know you're terrified to call," Zeller says, but she wants industry to know that she considers herself to be an "ombuddy" to manufacturers.

FDA Compliance

'Perfect Storm' Arrives: Clock Ticking For Device Firms To Conform To ISO 13485, MDSAP, EU & ASEAN Regs

Device manufacturers that haven't begun conforming to various ongoing international regulatory changes are behind the 8-ball and risk noncompliance, industry insider Kim Trautman says.

Regulation United States
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