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Industry ID’s Top Guidance Wish List From FDA

Walter Eisner • Tue, April 4th, 2017

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Each year, the Food and Drug Administration (FDA) publishes two lists of Draft Guidances the agency hopes to finalize during the next year. The agency divides these into "A" and "B" lists, based on which guidances are most important.

In February 21, 2017, medical device companies, through the largest industry group, AdvaMed, identified 7 of the 12 FDA 2017 draft guidance documents from the "A" list most important to the companies.

Those seven “A” list guidance documents are:

  1. Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices. AdvaMed says 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 "That being said, the narrow scope of the draft guidance greatly reduced its usefulness. We urge FDA to revise the draft guidance in a manner that reflects our comments."
  2. Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices.
  3. New or revised procedural guidances for MDUFA IV implementation.
  4. 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
  5. Use of Standards in FDA Regulatory Oversight of Next Generation Sequencing (NGS)- Based In Vitro Diagnostics (IVDs) Used for Diagnosing Germline Diseases
  6. Use of Public Human Genetic Variant Databases to Support Clinical Validity for Next Generation Sequencing (NGS) – Based In Vitro Diagnostics
  7. Infectious Disease Next Generation Sequencing Based Diagnostic Devices: Microbial Identification and Detection of Antimicrobial Resistance and Virulence Markers

On the FDA’s "B" list for final guidance, AdvaMed points to two documents of highest priority to its members:

  1. FDA Categorization of Investigational Device Exemption (IDE) Devices to Assist the Centers for Medicare & Medicaid Services (CMS) with Coverage Decisions.
  2. Unique Device Identification (UDI): Direct Marking of Devices

AdvaMed recommends FDA move this guidance to the "A" list because direct marketing compliance dates for certain products began in 2016. The association says the 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," stated the AdvaMed response.

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

To read the entire AdvaMed response, click here.

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