FDA CDRH 510(k) New Paradigm Guidance

FDA CDRH Guidance for Industry “The New 510(k) Paradigm: Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications” issued March 20, 1998. This document defines two new approaches to 510(k) Submissions. Iin addition to the normal submission this document defines requirements for special and abbreviated 510(k) submissions. Neither is required but each can have advantages over traditional submissions. A special 510(k) can be used for certain types of changes to a device that has been previously cleared by a traditional or abbreviated 510(k) provided that 8 declaration of conformity to design controls is included. Special 510(k)s include significantly less at documentation than other 510(k)s. An abbreviated 510(k) can be used to reduce the amount of documentation in the Submission if a manufacturer declares conformity to relevant standards recognized by the FDA. FDA publishes a list of recognize standards and what documentation can be omitted should conformity be declared to each.

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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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