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A Guide to the FDA’s Breakthrough Device and Safer Technologies Programs Management Report

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WCG FDAnews

WCG FDAnews


FALLS CHURCH, Va. (PRWEB)

Special Pathways for Innovative Devices:

A Guide to the FDA’s Breakthrough Device and Safer Technologies Programs

https://www.fdanews.com/products/61859

Want to get medical devices to market faster? Want all the perks of acceptance into the FDA’s Breakthrough Devices Program or Safer Technologies Program (STeP) without the hassle? Special Pathways for Innovative Devices: A Guide to the FDA’s Breakthrough Device and Safer Technologies Programs is the answer.

The agency’s special review pathways offer much to the manufacturers of the devices accepted, from additional FDA consultation to priority review status. But if one is at all unclear on the specific criteria, intricacies of the submission process and detailed benefits, one is missing out.

Special Pathways for Innovative Devices explains all of this and more, including reimbursement considerations for program-approved devices. This report will empower readers to understand and use to one’s advantage:


  • Eligibility requirements for both programs

  • Timing and content of submissions

  • Review process

  • Unique handling for combination products

  • Reasons for withdrawal of breakthrough device designation

  • Outlook for reimbursement for digital health products

  • Impending repeal of the Medicare Coverage of Innovative Technology (MCIT) rule and its impact on breakthrough devices

Getting a breakthrough or STeP designation can propel your device to success. This success begins with Special Pathways for Innovative Devices: A Guide to the FDA’s Breakthrough Device and Safer Technologies Programs.

Management Report Details:

Special Pathways for Innovative Devices:

A Guide to the FDA’s Breakthrough Device and Safer Technologies Programs

https://www.fdanews.com/products/61859

Price:

$397

Easy Ways to Order:

Online: https://www.fdanews.com/products/61859

By phone: 888.838.5578 or 703.538.7600

About FDAnews:

FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews’ print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA’s complex and ever-changing regulations

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