EMERGO SUMMARY OF KEY POINTS:

• The US FDA and National Institutes of Health have launched a new writing tool for medical device companies seeking approval to conduct clinical trials.
• The new clinical trial protocol template was first proposed in early 2016.
• The template is intended to help applicants seeking Investigational Device Exemption (IDE) approvals.

US regulators at the Food and Drug Administration and the National Institutes of Health (NIH) have published a new writing tool for use in applying for regulatory approval to conduct clinical trials for medical devices and pharmaceuticals.

Developed jointly by the FDA and NIH, the new clinical trial protocol template is now available for applicants seeking Investigational Device Exemption (IDE) or Investigational New Drug (IND) approvals. As previously reported by Emergo, the agencies first proposed the template in April 2016.

The new template is specifically intended for use in developing Phase Two and Phase Three clinical trial protocols.

Related US clinical trial services from Emergo:

• Clinical trial study design and protocol development for medical device companies
• FDA Pre-Sub consulting for IDE applicants
• Whitepaper: Clinical data to support FDA 510(k) submissions