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New pilot program could overhaul traditional health FDA practices

FDA

With interest from over 100 companies, the Food and Drug Administration is diving into its Digital Health Innovation Action plan, and has named nine companies who will become part of its new pilot plan, Pre-cert.

All companies were chosen on the basis of size, level or risk, high profile and level of quality throughout their operations within the digital industry.

The scheme will look at how technologies approach the area of quality control with regards to a growing healthcare focus, and subsequently streamline its approach towards this growing trend, enabling companies to bring products to market quicker, whilst adopting high levels of quality and safety throughout the process, leading companies to become pre-certified.

Such analysis will also enable the development of performance indicators to enable pre-certification going forward. "We need to modernise our regulatory framework so that it matches the kind of innovation we’re being asked to evaluate,” commented FDA Commissioner, Dr Gottlieb.

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“This helps foster beneficial technology while ensuring that consumers have access to high-quality, safe and effective digital health devices. These pilot participants will help the agency shape a better and more agile approach toward digital health technology that focuses on the software developer rather than an individual product."

The nine companies are as follows…

  1. Apple
  2. Fitbit
  3. Samsung
  4. Johnson & Johnson
  5. Pear Therapeutics
  6. Roche
  7. Tidepool,
  8. Verily
  9. Phosphorous

Such developments will see the eradication of traditional blockages and revise current regulations towards current and developing healthcare services and products, which can then be received by the patients in weeks and not months.

Corey McCann, President and Chief Executive Officer of Pear Therapeutics has stated: “We commend the FDA’s Digital Health Innovation Action Plan initiative and the speed with which they are moving towards building a regulatory pathway to bring these important products to patients.

We are honoured to be at the table with these eight other companies and the FDA as we help write the new chapter on digital health and digital therapeutics.”

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