FDA Electronic Submission Gateway

FDA announced in the Federal Register (Docket No. 1992S–0251) a central Gateway/single point of entry for electronic submissions for device, drug and biologic applications. It is referred to as the Electronic Submission Gateway (ESG).

The announcement describes three secure options for electronic submissions:

“The FDA ESG offers two secure communication options for applicants that have established gateway systems. One utilizes simple mail transfer protocol (SMTP) with secure multipurpose internet mail extensions (S/MIME) to provide secure e-mail communication and the other supports faster information exchange and utilizes hypertext transfer protocol secure (HTTPS) to provide real-time Internet communication. The FDA ESG also offers a secure WebTrader submission option for applicants who do not have gateway systems. The WebTrader is a no-cost applet which can be downloaded from FDA and requires only a standard security certificate to provide the applicants with a secure Internet connection to FDA.”

The full text of the announcement is at this link:  http://www.fda.gov/OHRMS/DOCKETS/98fr/E6-12808.pdf

Remote Webmeeting Assessments

SoftwareCPR can provide remote offsite assessments to support virtual offices.  Our consultants can utilize webmeeting tools to walk your teams through assessments such as:

  • 62304 compliance
  • Regulatory submission pre-review
  • Software risk analysis
  • Cybersecurity process and validation
  • Overall ISO 14971 risk management
  • Overview of software regulation with John Murray

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