Medtech Insight is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

United States

Set Alert for Policy and Regulation United States

Expect FDA Diagnostics-Reform Bill Passage In 2019, Rep. DeGette Says

Passage of a US FDA diagnostics reform bill is one priority for the US House Energy and Commerce Committee in 2019, said cosponsor and committee member Rep. Diana Degette, D-Colo.

Legislation In Vitro Diagnostics Regulation
Advertisement

Latest From United States, Policy & Regulation

AdvaMed Code Update Focuses On Compliance Standards

AdvaMed has revised its industry Code of Ethics. The revised code, which will come into effect in 2020, includes new sections on off-label communications and training health-care professionals to use new medical technology.

Compliance Medical Device

DTC Ads For Genetic Tests Increased 18-Fold Over 20 Years, Study Says

The number of direct-to-consumer advertisements for molecular-based tests rose exponentially from 1997 to 2016, according to a medical marketing analysis released earlier this month in the Journal of the American Medical Association. Simultaneously, laboratory test manufacturers increased spending on ads and direct spending on physicians who work with the tests from $75.4m to $82.6m.

In Vitro Diagnostics Advertising, Marketing & Sales

About Three Months' Worth Of Carryover Device Fees Remaining, FDA's Gottlieb Says

US FDA has about three months' worth of medical device carryover user-fee funds to burn if the partial federal government shutdown continues, although the agency is still finalizing its shutdown balance sheet, Commissioner Scott Gottlieb says.

FDA Regulation

Pre-Cert Program Will Start Off Slow With De Novo Framing, But Big Questions Remain

Several experts suggest FDA is toeing the line in keeping the first stage of its pre-certification program for software-as-a-medical-device products legally permissible, but it may be limited in scope for the time being. Meanwhile, one attorney says the agency is sending mixed messages about whether the current program will sit comfortably within FDA's current authorities.

Digital Health Regulation

New Finance Chair Grassley Will Push Device Tax Repeal, Try To Lower Health-Care Costs

In setting his agenda for the US Senate Finance Committee in 2019, incoming Chairman Chuck Grassley, R-Iowa, says he will continue to cosponsor bills to end the device tax, focus on lowering prescription drugs and other medical product health-care costs, expand tax breaks for business, and make sure Congress has a strong hand in negotiating trade and tariff talks.

Legislation Regulation

2019 Will Be Testing Period For US FDA's Novel Pre-Cert Paradigm For Digital Health

In 2019, FDA will be taking steps to perform real-world testing of the effectiveness of its pre-cert program for health software and whether the program can be carried out within the agency's current regulatory authorities. The efforts come after more than a year of development and some pushback about statutory overreach and patient safety.

Regulation Digital Health
See All
UsernamePublicRestriction

Register