Medtech Tips: 7 Expert Pointers For A Successful Pre-Market Submission To US FDA
FDAer-turned-consultant Heather Rosecrans offers valuable tips for a successful submission, from avoiding sending a PMA or 510(k) to the agency during the annual holiday season, to requesting a copy of an FDA reviewer's work through a Freedom of Information Act request – and more.
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Philips will make 43,000 medical ventilators by the end of 2020 for use in the US and manufacture 2,500 more for the Strategic National Stockpile in a contract worth more than half a billion dollars.
COVID-19: String Of FDA Guidance Docs Lay Bare Enforcement Policies For Infusion Pumps, ECMO Devices, Thermometers, And More
In three separate immediately-in-effect guidance documents, the US agency says makers of infusion pumps and accessories, extracorporeal membrane oxygenation (ECMO) and cardiopulmonary bypass devices, and remote ophthalmic assessment and monitoring devices can make “limited modifications” to those products so they can be used during the ongoing novel coronavirus crisis, without the need for firms to seek out a new 510(k). A fourth guidance says clinical electronic thermometers that aren’t yet 510(k)-cleared by the FDA can be distributed for use.
In a letter to the medtech industry, the FDA’s William Maisel says the US agency will hold remote meetings with device makers and other stakeholders through the end of May. The FDA also extended due dates for marketing applications by 90 days.