This Article deals with the Updates for the Breakthrough Devices Program Guidance reducing Disparities in Health and Health Care. The FDA which is an authorized agent for Registrations in the country has developed a draft guideline to suggest minor updates to the Breakthrough Devices Program guidance.
- The objective of this programme is to simplify the development, assessment, and review of certain medical devices while maintaining the legislative requirements for market approval, clearance, and De Novo marketing authorisation, in line with the Agency’s objective to protect and advance public health.
- The Breakthrough Devices Program has taken the place of the Accelerated Access Pathway (EAP) and Innovation Pathway, which both aim to promote the creation and certification of breakthrough technology (BDP). Due to the FDA’s consistent vision and designation criteria, products designated under the EAP are now regarded as being a part of the Innovative Devices Program.
- The Priority Review Program, which applied legislative standards for allocating priority consideration to premarket submissions for medical devices and offered standardized procedures to establish an effective priority review process, is likewise replaced by the Breakthrough Devices Program. Even so, Breakthrough Devices will be granted priority assessment in line with Section 515B of the FD&C Act.
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Source : USFDA
