AdvaMed Boils Down Top Priority FDA Guidance Documents for 2017

Regulatory NewsRegulatory News | 09 March 2017 |  By 

Medical device industry group AdvaMed pointed to seven guidance documents slated for release in 2017 by the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health as those that are of the highest priority to its member companies.

In addition to recommending that FDA finalize all of the draft guidances issued within the last year, the list of seven final guidance documents (of the 12 listed in FDA’s "A" list for 2017, meaning the agency has also prioritized them above others) include:

  • Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices: "This is an important developing area that guidance with the appropriate scope would help foster. That being said, the narrow scope of the draft guidance greatly reduced its usefulness. We urge FDA to revise the draft guidance in a manner that reflects our comments."
  • Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices.
  • New or revised procedural guidances for MDUFA IV implementation.
  • Suggested Format for Developing and Responding to Deficiencies of Standards in FDA Regulatory Oversight of Next Generation Sequencing (NGS) - Based In Vitro Diagnostics (IVDs) Used for Diagnosing Germline Diseases
  • Use of Standards in FDA Regulatory Oversight of Next Generation Sequencing (NGS)- Based In Vitro Diagnostics (IVDs) Used for Diagnosing Germline Diseases
  • Use of Public Human Genetic Variant Databases to Support Clinical Validity for Next Generation Sequencing (NGS) – Based In Vitro Diagnostics
  • Infectious Disease Next Generation Sequencing Based Diagnostic Devices: Microbial Identification and Detection of Antimicrobial Resistance and Virulence Markers

In terms of draft guidance, AdvaMed singles out three of the four FDA listed, including: "Update to Section V Demonstrating Insignificant Risk of an Erroneous Result in the Recommendations: Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices guidance," "Dual 510(k) and CLIA Waiver," noting the group also supports the "issuance of this guidance to support the overall dual submission process and foster efficient and effective review and waiver of these critical devices, which play an important role in providing timely and effective care for patients," and "New or revised procedural guidances for MDUFA IV implementation."

On FDA’s "B" list for final guidance, AdvaMed also points to two documents of highest priority to its members: "FDA Categorization of Investigational Device Exemption (IDE) Devices to Assist the Centers for Medicare & Medicaid Services (CMS) with Coverage Decisions" and "Unique Device Identification (UDI): Direct Marking of Devices."

For the guidance on UDIs, AdvaMed recommends "FDA move this guidance to the ‘A’ list because direct marking compliance dates for certain products began in 2016. Changes in interpretation will be costly and would create uncertainty regarding products in commercial distribution. Issuance of this guidance well in advance of the 2018 compliance date will provide manufacturers with the ability to plan and implement."

The group further calls on FDA to add two final guidance documents to its "A" list for 2017 on 510(k) modifications and software modifications.

AdvaMed Comment


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