During a speech in early December last year, Bill Maisel, the deputy director for science at the FDA’s Center for Devices and Radiological Health, expressed a positive outlook for the new medical device industry.
The center supervises medical device approval. Maisel said that the center had made great strides with fixing how long it takes to approval trials and yet-to-be-approved medical devices.
The comments regarding this topic were made at FDA Update, which is an event for MassMEDIC members. MassMEDIC is a medical equipment industry advocacy group. FDA Update provided members a snapshot of important issues regarding regulatory approval.
An MIT and Harvard graduate, Maisel addressed various advances the center has made in getting new medical devices to the American public. He said the agency will match or improve upon its own deadlines for approvals. And in the past few years, they have halved its long list of pending medical device approvals.
He said the agency cut the average time frame between an application’s submission and possible approval by 75 percent in three years. It took around 400 days to process applications in 2011, whereas it only too around 101 days in 2014.
He also said the agency tried to analyze whether a new piece of medical equipment should be reclassified from high-risk to less-demanding devices to help expedite the decision-making process.
Additionally, a new “Expedited Access PMA” program will create more communication avenues between high-risk product companies and the agency. Maisel hopes also to better its level of customer service. They will collect feedback and eventually hope to achieve a 70 percent satisfaction rate with government agencies who work with the FDA and industry representatives.
He said the Center for Devices and Radiological Health reached an 84 percent approval rating, which surpassed their goal.
Ultimately, he wants U.S. patients to have first access to the latest and best technology to hit the market – a goal for 2015.
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