SOURCE: Cutting Edge Information

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February 16, 2017 07:16 ET

Top US Medical Device Companies Look to 501(k) Clearance to Support Class 2 Devices and PMAs for Class 3 Products

RESEARCH TRIANGLE PARK, NC--(Marketwired - February 16, 2017) - Sixty five percent of surveyed medical device companies report using a 501(k) clearance pathway for Class 2 devices, and 50% trend towards pre-market approvals (PMAs) for regulatory submissions of Class 3 drugs, according to a study by business intelligence firm Cutting Edge Information.

The study, Medical Device Development: Benchmarking Early-Stage Product Management and Promotion, reveals that the majority of surveyed medical device manufacturers report using either pre-market approval or a 510(k) clearance pathway. And although companies' chosen regulatory pathways are technically independent of the device class, there is a correlation between the two.

On average, Class 2 devices trend toward 510(k) approval while Class 3 products often require PMA submissions. For Class 2 devices, 65% of surveyed device manufacturers report using a 510(k); 19% report pre-market approval. Aside from the half of the surveyed device companies that look to PMAs for regulatory approval of Class 3 devices. another 31% use 510(k) with clinical trials to support product approval; only 13% report using a 510(k) sans clinical trials.

"While medical device manufacturers can choose from multiple regulatory registration options, selecting the best-fit pathway can be challenging," said Adam Bianchi, senior director of research at Cutting Edge Information. "This process can be especially difficult for start-up companies, which have little to no experience with the marketplace."

The study found that the majority (75%) of surveyed Top 50 manufacturers use 510(k) for Class 2 devices. However, for supported Class 3 devices, 20% of surveyed Top 50 manufacturers use 510(k), and another 20% use 510(k) with clinical trials to gain approval. The surveyed small device companies more commonly look to 510(k) with clinical trials compared to larger companies. These small manufacturers are also the only companies to report using other regulatory pathways.

Medical Device Development: Benchmarking Early-Stage Product Management and Promotion, available at, explores the resources and best practices necessary to support new product planning and commercialization for US-based medical device launches. This benchmarking study, conducted through primary research, includes:

  • Profiles of medical device firms and their products, highlighting human and financial resources supporting development and commercialization, product development timelines and expected commercial success.
  • Data on anticipated US commercial success, including market size, market share and competition levels.
  • Commercial board staffing benchmarks as well as best practices for integrating stakeholders across multiple firms and communicating throughout the development process.
  • Expert insights on selecting the best regulatory pathways for emerging medical technology products, implementing clinical trials and partnering to support development.

To learn more about Cutting Edge Information's primary benchmarking research on medical device development and commercialization, or other life sciences topics, please download the brochure at:

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