by Priya Bhutani, CEO RegDesk –
Summary Technical Document (STED) is the proposed harmonized format used for regulatory submissions by the Global Harmonization Task Force (GHTF). Albeit STED is in its pilot phase, it has the potential to standardize format for regulatory submissions across jurisdictions in the long term. The STED format is accepted by multiple regulatory authorities globally.
CDRH initiated a pilot program in June 2003 to assess the feasibility of the STED format. The FDA has a guidance document titled, “A Pilot Program to Evaluate a Proposed Globally Harmonized Alternative for Premarket Procedures” which provides and alternative to the traditional submission procedure. FDA plans on continuing the STED pilot program until they have sufficient data to draw conclusion on the suitability of the STED format.
All devices are eligible to participate in the STED pilot program. However, the following submissions are not eligible:
- Special 510(k)s
- In vitro diagnostic submissions
- Product development programs (PDP)
- Humanitarian device exemptions (HDEs)
- Not all PMA supplements
As a medical device manufacturer you can volunteer to partake in the STED pilot program while submitting the 510(k). The submission should include the following elements in the beginning of the submission, as applicable:
- Trade name and classification name of the device
- Establishment registration number
- Device class or a statement that the device is not yet classified
- 510(k) summary or Statement
- Financial certification or disclosure statement for a 510(k) including clinical study
- Class III certification ans summary for all Class III devices
- Truthful and Accurate Statement
- Indications for Use
- Substantial Equivalence
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