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Class II UDI Compliance Deadline Approaches

7/25/2016

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Today FDA released the DRAFT FDA guidance "Unique Device Identification System: Form and Content of the Unique Device Identifier."  While FDA's final rule was passed September 24, 2014, this is their first guidance on the subject.

This, and its final draft, is a must read for all medical device regulatory professionals.   It's time to update your Labeling SOPs. 

Links from the guidance brought me to the Compliance Dates for UDI Requirements page, found here. 

Importantly, this September 24th, 2016, manufacturers of Class II medical devices must be in compliance with the rule and begin labeling with UDI. 

FDA-Accredited Issuing Agencies are able to help manufacturers put in place the systems required to appropriately label per the UDI rule.

For help with your Class II UDI, visit the Contact page and send me a note.   

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Part 1: Observations from the US House Passed 21st Century Cures Act – Required Guidance Documents and Projected Timelines for Completion

7/12/2016

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The U.S. House of Representative passed the 21st Century Cures Act in July of 2015.  It was then sent over to the U.S. Senate and has since been referred to the Senate Committee on Health, Education, Labor, and Pensions. 
Within this bill there are references to 22 (from my count) guidance documents FDA is required to author if the bill is passed. 
Below is the list guidance documents I identified that the FDA will be required to create or update and complete once the 21st Century Cures Act is signed into law.  I have also included the House of Representatives projected timelines for completion, which may change in the Senate.   Because the Senate has yet to take up and pass this legislation, allowing the President to sign it into law, some of the projected completion dates for certain guidance’s are unlikely to be met.   I will update this list with any changes based on a Senate passed bill.           
Guidance List:
  1. Guidance on the implementation of subsection (y) [development and use of patient experience data to enhance structured risk-benefit assessment framework] of Section 505 (New Drugs) of the Federal Food, Drug, and Cosmetic Act – Not later than 3 years after enactment of this Act, draft guidance published.
  2. Guidance to implement such Section 507: Qualification of Drug Development Tools (biomarkers, surrogate endpoints, etc). – Not later than 24 months after the date of implementation of this Act, draft guidance published
  3. Issue and periodically update guidance to assist sponsors in the development of a precision drug or biological product, including the development of companion diagnostics in the context of a drug development program – Not later than 18 months after the date of the enactment of the 21st Century Cures Act
  4. Draft guidance addressing the use of adaptive trial design for drugs and biological products – Not later than 18 months after the date of the public meeting (update and finalize draft guidance)
  5. Draft guidance on the use of Bayesian methods in the development and regulatory review and approval or licensure of drugs and biological products. – Not later than 48 months after the date of the public meeting (update and finalize draft guidance)
  6. Guidance for industry on the circumstances under which sponsors of drugs and the Secretary may rely on evidence from clinical experience for the purposes described in subsection (a)(1) or (a)(2) – Not later than 36 months after the date of enactment of this section, issue draft guidance for industry; not later than 48 months after the date of enactment of this section, after providing an opportunity for public comment on the draft guidance, issue final guidance
  7. Guidance for industry on the appropriate standards and methodologies for collection and analysis of evidence from clinical experience submitted for such purposes – Not later than 36 months after the date of enactment of this section, issue draft guidance for industry; not later than 48 months after the date of enactment of this section, after providing an opportunity for public comment on the draft guidance, issue final guidance
  8. Issue final guidance for implementation of the streamlined data review program established under section 505H of the Federal Food, Drug, and Cosmetic Act, and include in such guidance the process for expanding the types of indications to be subject to the streamlined data review program, as authorized by section 505H(c)(1)(B) of such Act – Not later than 24 months after the date of enactment of this Act
  9. Finalizing draft guidance on expanded access; shall clearly define how the Secretary of Health and Human Services interprets and uses adverse drug event data reported by investigators in the case of data reported from use under a request submitted under section 561(b) of the Federal Food, Drug, and Cosmetic Act – Not later than 12 months after the date of enactment of this Act, the Secretary of Health and Human Services shall finalize the draft guidance entitled “Expanded Access to Investigational Drugs for Treatment Use—Qs & As” and dated May 2013.
  10. Guidance on facilitating the responsible dissemination of truthful and non-misleading scientific and medical information not included in the approved labeling of drugs and devices – Not later than 18 months after the date of enactment of this Act
  11. Guidance describing criteria, process, and other general considerations for demonstrating the safety and effectiveness of antibacterial and antifungal drugs to be approved for use in a limited population in accordance with section 505(z) of the Federal Food, Drug, and Cosmetic Act, as added by subsection (b) – Not later than 18 months after the date of enactment of this Act
  12. Final guidance that describes the responsibilities of each agency center regarding its review of combination products. The Secretary shall, after soliciting public comment, review and update the guidance periodically – Not later than 18 months after the date of the enactment of the 21st Century Cures Act
  13. Priority review guidance – Prior to finalizing the guidance under paragraph (1), the Secretary shall propose such guidance for public comment
  14. Criteria for quality system certification – third party quality system assessment program – Draft guidance not later than 12 months after the enactment of the 21st Century Cures Act; and final guidance not later than 12 months after issuance of the draft guidance
  15. DRAFT guidance document updating the October 4, 2002, guidance document entitled ‘The Least Burdensome Provision of the FDA Modernization Act of 1997: Concept and Principles; Final Guidance for FDA and Industry’ – Not later than 12 months after the date of enactment of the 21st Century Cures Act
  16. DRAFT guidance identifying the principles for recognizing standards, to consider the experience with, and reliance on, a standard by other Federal regulatory authorities and the device industry; and whether recognition of a standard will promote harmonization among regulatory authorities in the regulation of devices – Not later than 12 months after the date of the enactment of the 21st Century Cures Act; final guidance not later than 12 months after the close of the public comment period for the draft guidance under clause
  17. Guidance document that defines the criteria for establishing “probable benefit” as that term is used in section 520(m)(2)(C) of the Federal Food, Drug, and Cosmetic Act – Not later than 18 months after the date of enactment of this Act
  18. Draft guidance that revises “Section V. Demonstrating Insignificant Risk of an Erroneous Result ‘Accuracy’” of the guidance entitled “Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices” and dated January 30, 2008 – Not later than 12 months after the date of the enactment of this Act; and Final revised guidance not later than 12 months after the comment period for such draft guidance closes
  19. Regulations and guidance to facilitate the broader use of single, central, or lead institutional review boards – Not later than 36 months after the date of enactment of this Act
  20. Guidance with respect to the implementation of section 3010 of the Public Health Service Act, as added by paragraph (1), including with respect to defining and providing examples of authorized use under applicable State or Federal law of health information – Not later than January 1, 2017
  21. Guidance to clarify the relationship of the provisions of the HIPAA privacy and security law, as defined in section 3009(a)(2) to information blocking – Not later than January 1, 2017
  22. Guidance to further the voluntary transition of health care providers between different certified EHR technology (as defined in section 3000(1) of the Public Health Service Act by removing disincentives to such transition, which may include applying to instances of such a transition the hardship exemption authority under section 1848(a)(7) of the Social Security Act and other provisions of law in existence as of the date of the enactment of this Act. In developing such guidance, the Secretary may consult with the relevant Federal agencies – Not later than January 1, 2018
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    John Van Hoven, MS

    I started this blog to document my thoughts on working in the medical product regulatory field, in particular my experiences working with the FDA.  I hope you find it somewhat helpful. 

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