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FDA Releases New Medical Device Safety Action Plan

Posted May 3, 2018

The FDA is exploring whether it can move more quickly to require medical device companies to respond to reported problems with their products. On April 17th, the Food and Drug Administration released its Medical Device Safety Action Plan (MDSAP), a series of proposed steps to improve the federal government's oversight of medical devices. Some of the proposed changes, like special controls authority, may need action by Congress.

Read the full plan: Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health

MDSAP is designed to speed up the 510(k) review process to help get new devices approved quicker, create a robust premarket and post–market device review, to better access risk and evaluate the lifespan of certain devices. The new plan would also implement better cybersecurity practices for medical devices.

FDA is looking to develop the National Evaluation System for health Technology (NEST), an active surveillance and evaluation system linking clinical registries, electronic patient health records (EMRs), and medical billing claims. The agency hopes to flag potential issues with medical devices faster using this network compared with its current voluntary reporting system.

By Patrick Cooney, The Federal Group, Inc.
Legislative Representative, Dental Trade Alliance


Fred Freedman
Vice President Membership Support and Engagement, Dental Trade Alliance