Regulatory Affairs

ARTICLES

House Sets Deadline for HHS to Develop Bill of Materials Action Plan

The House Energy and Commerce Committee is giving the Department of Health and Human Services until no later than Dec. 15 to come up with an action plan for creating “bills of materials” to enhance cybersecurity for healthcare technologies. Read More

Bill on Use of New Medical Devices for Soldiers Heads to White House

The Senate gave final congressional approval to a bill designed to resolve a dispute involving the FDA and the Department of Defense, preserving the FDA’s authority over authorizing innovative medical devices for soldiers while streamlining the authorization process. Read More

The EMA Gets a New Home: Amsterdam

The European Union landed on Amsterdam as the new home for the European Medicines Agency headquarters, following three rounds of voting and a tiebreaker against Milan. Read More

India to Enforce New Code for Marketing Devices

As India gets ready to enforce its new medical device regulations in January, the government is gearing up to release a new uniform code for medical device marketing practices. Read More

CAMD Releases MDR/IVDR Implementation Roadmap

The EU’s Competent Authorities for Medical Devices, the umbrella group through which the EU’s national competent authorities work to enhance the single market for devices, released a new roadmap with a priority list of areas of focus for implementing the new European MDR/IVDR regulations. Read More

FDA Unveils 3-Tiered Approach to NGS Oncology Testing

The FDA is taking a three-tiered approach to next-generation sequencing oncology with a newly approved tumor profiling assay, the accreditation of the New York Department of Health as an FDA third-party reviewer, and the creation of the Class II regulatory pathway for these devices. Read More

NPPA to Revisit Price Controls on Coronary Stents in Early 2018

India’s National Pharmaceutical Pricing Authority said it will revisit the ceiling prices imposed earlier this year on coronary stents. Read More

FDA Issues Final Guidance on Direct Marking Requirements for UDIs

The FDA released final guidance on requirements for direct marking of devices with unique device identifiers. The final document closely resembles the draft version issued in June 2015. Read More

FDA Proposes New Framework for Regenerative Medicine and Combo Products

The FDA’s newly unveiled regenerative medicine framework contains guidance on when premarket review is required and how to expedite… Read More

MedTech Europe Highlights Numerous Flaws, Needed Solutions for Brexit Plan

MedTech Europe is very concerned about the implications of a divergence in the regulatory framework for medical devices and… Read More