Wednesday, July 7, 2010

FDA CDRH 513(g) Medical Device Classification and Clinical Submission

The FDA CDRH 510(k) submission is the most common regulatory pathway to filing for most medical devices in the US. The 510(k) clinical submission is designed to demonstrate that a medical device product under clinical development is at least as safe and effective or substantially equivalent (SE) to a predicate device, already approved and legally marketed and follows safety surveillance. The information collected, compiled and presented in a 510(k) medical device clinical submission includes but is not limited to the following data and documentation:
  • preclinical
  • nonclinical
  • clinical
  • performance
  • comparative
  • supportive
  • supplemental
  • competitive
  • predicate
  • intended use
  • QRS
  • QA
  • QC
  • SOPs
  • label
  • inserts
  • instructions for use
  • brochure
  • WIs
  • QMP
  • DMP
  • CDP
  • protocol, process, procedure
  • safety
  • efficacy
  • previously submitted regulatory data and documentation US, non-US
  • previously approved clinical submission US, non-US
  • literature
  • briefing documents
  • CE Mark - Europe
  • ROW and Country-Specific "Notified Body" Opinions
  • IRB
  • software, hardware, array, platform, otherwise
  • other.

Within FDA/CDRH, 2 offices for medical device evaluation exist, the Office of Device Exemption (ODE) and the Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD).

Under FD&C Act, Section 513(g), a sponsor, manufacturer, submitter or person may request a medical device classification for clarity and decision, when a question arises pertaining to a regulatory path to filing or simply "how to submit". The FDA guidance in such cases will evaluate and examine each medical device product case by case and come to a decision as a result of filing a 513(g) clinical submission.

Section 513(g) of the Act:

  • "Within 60 days of the receipt of a written request of any person for the information respecting the class in which a device has been classified or the requirements to a device under this Act, the Secretary shall provide such person a written statement of the classification, if any, of such device and the requirements of this Act applicable to the device".

Section 513(g) Clarity and Classification Inquiries - to determine regulatory / clinical submission path:

  • determine whether a medical device is subject to FDA regulations
  • determine whether a medical device is exempt from the 510(k) requirements of the Act
  • determine whether a 510(k) is needed for a modification to the respective device
  • determine the regulatory path for the medical device.

Determination of medical device classification provides important decision making information for future manufacturers, investors, co-development partners, strategic alliances, strategic partners, marketing partners, and otherwise. This guidance provides valuable information pertaining to the appropriate and applicable standards of a successful clinical submission, regulatory timelines, development costs, resources, helps to estimate "realistic" time to submission, "realistic" time to market, regulatory strategy for successful, comprehensive, "real-time" product commercialization.

As always, ensure quality, accuracy, consistency of data, documentation, format, presentation, statement and previously submitted filings. Lead submissions, manage issues, QC, QC, QC, monitor, monitor, monitor CROs and all outsourced resources and contracts. Ensure on time quality, compliant and complete contracted deliverables. Go to for expert gate keeper clinical development and submission leadership, resources, teams, quality management and services. Visit our live interactive seminar/webinar page.

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