Medtech, healthcare stakeholders offer ideas to improve FDA oversight, regulation and patient access

Major players and medtech industry groups have offered their opinions as the FDA looks to review and improve its information collection requirements and regulatory oversight. Commentary came in from companies Johnson & Johnson (NYSE:JNJ), Abbott (NYSE:ABT) and Cook Medical and industry groups AdvaMed, the Medical Imaging & Technology Alliance, the Pharmaceutical Research and Manufacturers of America and the American Hospital Association, amongst many others. Across the board, companies and groups left commentary that was supportive of the FDA’s effort to reduce the burden on parties regulated by the agency to improve efficiency and innovation in the industry. In its comments, J&J prioritized improving avenues for communicating drug and device data to healthcare professionals and payors, the ability to change labels without FDA approval and revising the FDA’s application of conflict of interest regulations in relation to advisory committee membership. The company also supported the implementation of electronic labeling for drugs and medical devices, a continued pause on the FDA’s program for the voluntary reporting of quality data, simplification of electronic records and data regulations and a system that would allow initial marketing of breakthrough class III medical devices based of CE Mark approval. Abbott offered multiple opinions on ways to improve medical device reporting and its associated regulations, including revised guidance and improved clarit...
Source: Mass Device - Category: Medical Devices Authors: Tags: Food & Drug Administration (FDA) Regulatory/Compliance Abbott AdvaMed American Hospital Assn. Cook Medical johnsonandjohnson Medical Imaging & Technology Alliance (MITA) Pharmaceutical Research & Manufacturers of America (PhRMA) Source Type: news