USA Regulatory ServicesAt MedReg, we provide end-to-end regulatory support for FDA 510(k) submissions, helping medical device manufacturers navigate the premarket clearance process and prepare a comprehensive submission in accordance with applicable FDA requirements.
Types of 510(k)
- Traditional 510(k): The Traditional 510(k) may be used for any original 510(k) or for a change to a previously cleared device under 510(k).
- Special 510(k): Device manufacturers may choose to submit a Special 510(k) for changes to their own existing device.
- Abbreviated 510(k): Device manufacturers may choose to submit an Abbreviated 510(k) when the submission relies on: FDA guidance document(s), Demonstration of compliance with special control(s) for the device type, or Voluntary consensus standard(s).
Process
- 510(k) Pathway Determination: We assess the applicability of a 510(k) submission and guide you in selecting the appropriate pathway: Traditional, Special, or Abbreviated 510(k); based on your device characteristics and applicable FDA requirements.
- Regulatory Guidance and Standards Identification: We identify relevant FDA guidance documents (Guidance Document Database) and applicable FDA-recognized consensus standards (FDA Recognised Consensus Standards Database) to support your device's regulatory strategy and testing requirements.
- Predicate Device Search and Selection: We conduct a detailed predicate device search and help identify the most suitable predicate device(s) to support the substantial equivalence demonstration.
- Testing Strategy and Standards Compliance: We provide guidance on identifying applicable performance, safety, biocompatibility testing requirements in accordance with relevant FDA guidance documents and recognized consensus standards. We also aid in identifying testing requirements for transport validation, packaging validation, sterilization validation, & mechanical testing where applicable.
- Preparation of Submission Documentation: We prepare and review the necessary technical and regulatory documents to support your 510(k) submission, including, but not limited to:
- Cover Letter
- Device Description
- Device Pictures / Images
- List of System Components
- Labelling (Immediate label, Instruction for Use (IFU), Surgical Technique, Packaging labels (secondary / tertiary))
- Substantial Equivalence Comparison
- Biocompatibility Evaluation
- Performance Testing Documentation, as applicable
- Summaries of test reports (transport validation, sterilization validation, biocompatibility reports, etc.) as applicable
- Reprocessing documentation where applicable
- Software Documentation as required
- Human Factors and Usability Engineering Evaluation, where applicable
- Executive Summary
- eSTAR Preparation: We assist in completing the FDA electronic Submission Template and Resource (eSTAR), which is required for 510(k) submissions unless an exemption applies.
- Electronic Submission Support: We support the finalization and electronic submission of the completed eSTAR package through the applicable FDA submission portal.
510(k) Process Timeline
- Day 0: eSTAR submission: 510(k) submission via eSTAR.
- Day 15: Acceptance review: Within 15 days of receipt of submission submitter receives results of acceptance review.
- Day 60: Substantive and interactive review: FDA conduct substantive review and interactive review.
- Day 90: FDA decision letter: FDA will issue the decision letter to the submitter.
FDA User Fees: FDA charges a user fee for reviewing 510(k) submissions. These fees are updated annually, at the beginning of each fiscal year starts from 1st October. We guide you on the applicable fee category and payment requirements for your submission.
