FDA approvals of novel medical devices hit record in 2018

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Alexander Gaffney Senior Manager, Health Research Institute, PwC US February 08, 2019

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Medical device manufacturers last year benefited from a higher number of novel medical device approvals than any other time in FDA history, joining branded and generic drug manufacturers who also saw record-setting approvals, according to the FDA.

The FDA approved 106 novel devices, defined as a device approved or cleared through the agency’s premarket approval, humanitarian device exemption, breakthrough premarket notification 510(k) and “De Novo” pathways. Agency officials said they also granted 112 Breakthrough Device Designation requests, indicating that the pipeline of future innovative products is large.

HRI impact analysis

The FDA’s expansive list of potential pathways is reflective of the many ways in which an innovative device can come to market. Like pharmaceutical products, devices can come to market based on varying degrees of evidence, novelty and similarity to other products. A device may be highly innovative and require clinical data, while others are intended for very small populations and approved based only on evidence of safety. Many other devices are novel, but not dangerous enough to require extensive clinical evidence.

While the new record is good news to the medical device industry, which saw fewer than half the current level of approvals and clearances as recently as 2013, the record is also likely the result of expanded use of particular review pathways and other operational improvements.

For example, recent legislation made the De Novo pathway considerably easier to use and more predictable, which led to almost a doubling of submissions in 2017, from 54 to 101, and the FDA has accelerated review periods from an average of 866 days per filing in 2009 to 280 days as of 2016, the last complete review cohort.

Contact us

Trine K. Tsouderos

HRI Regulatory Center Leader, PwC US

Tel: +1 (312) 241 3824

Alexander Gaffney

Senior Manager, Health Research Institute, PwC US

Tel: +1 (202) 836 1604

Jason Ranville

Senior Manager, Health Research Institute, PwC US

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