Washington, D.C. The Medical Imaging & Technology Alliance (MITA) – the leading trade association representing the manufacturers of medical imaging equipment, radiopharmaceuticals, contrast media, and focused ultrasound therapeutic devices – today issued the following statement regarding the directives in the President’s “Promoting Competition in the American Economy” Executive Order (EO) that address third-party repair or self-repair of goods.
“The Biden administration’s executive order addressing right to repair issues underscores the categorial differences between FDA-regulated medical devices used to diagnose disease, sustain life, and guide complex healthcare interventions and consumer electronics or farm equipment,” said Patrick Hope, Executive Director, MITA.
“Maintaining and repairing sophisticated medical device equipment raises both patient safety and cybersecurity concerns,” Hope continued. “The FDA laid out its roadmap to address medical device servicing and repair in its 2018 report. Moreover, the Agency has begun executing it through the issuance of remanufacturing guidance and their cybersecurity discussion paper. We look forward to continuing our collaborative work with the FDA and Congress to resolve these issues, which are central to patient safety and device effectiveness.”