Posted: 25 Jan 2018 08:29 PM PST
The title of this blog post should tell you everything you need to know about the proposed appeal regulations announced last week by CDRH (found here). On January 17, CDRH proposed regulations specific to the device appeal process for both 517A decisions as well as non-517A decisions. The notice announcing the proposed regulations states that they are intended to “provide transparency and clarity for internal and external stakeholders” on the device appeal process. However, in our view, the proposed regulations add nothing to the existing guidance available to industry and the Agency regarding the device appeal process.
By way of background, as we have previously posted on (here, here, and here), the device appeal process was significantly modified in the Food and Drug Administration Safety and Innovation Act (FDASIA), which created Section 517A of the Federal Food, Drug, and Cosmetic Act (FDC Act). Section 517A defined certain decisions by CDRH (e.g., 510(k) NSE, PMA denial and not-approvable decisions) that were subject to specific timeframes (i.e., appeal must be received by CDRH within 30 days from the decision and date) and bound CDRH to responding to such appeals:
The 21st Century Cures Act (Cures Act) expanded the list of Agency decisions subject to Section 517A procedures by adding decisions on breakthrough designation requests. In September 2017, CDRH revised its Q&A Guidance to include such decisions on the list of 517A decisions, resulting in the following list of decisions subject to the 517A requirements:
These lists obviously do not cover all FDA decisions. Most notably, de novo submissions are not included. Since FDASIA and the Cures Act (the statutes establishing and revising the device appeal process), de novo submissions have become subject to significant user fees (in excess of $90,000). When CDRH announced its proposed regulations addressing appeals, we hoped FDA would include de novo submissions in the list of 517A decisions, although not required by statute. Certainly given the new price tag, applicants should have the certainty associated with the appeal process for other significant premarket submissions. And, given the increased popularity of de novo applications, more companies are interested in that certainty.
The proposed regulations also do not include any Agency procedures (e.g., timing) for review of non-517A decisions. The notice announcing the proposed regulations does, however, discuss at length the naming of non-517A decisions. Section 517A of the FDC Act pertains to “significant decisions.” In its earlier guidance, FDA used this same terminology referring to 517A decisions as “significant decisions.” FDA stated that it did not want to refer to non-517A decisions as “insignificant decisions” (as may be implied by referring to 517A decisions as “significant”) because they are still important even though not expressly identified in Section 517A. Regardless, however, of what the regulations call these decisions, the lack of Agency procedures for their review highlights their insignificance when it comes to the appeal process and leaves appeals of these decisions at a significant disadvantage as compared to 517A decisions.
Much to our disappointment, the proposed regulations did not address either of these major issues. As indicated at the outset, the proposed regulations simply regurgitate the statutory timeframes and submission types for 517A decisions. With regard to non-517A decisions, the proposed regulations simply state that appeals must be filed by the applicant within 60 days of the decision. There are no requirements for the Agency with regard to reviewing or responding to such appeals. We find the lack of additional clarity and procedures in the proposed guidance somewhat astonishing given that industry and the Agency already understood these procedures and timeframes based on existing guidance. FDA is accepting comments on the proposed regulations through April 17, 2018. We strongly recommend those interested in the appeals process comment. These seemingly arcane procedural elements can help determine the outcome of a submission.
By way of background, as we have previously posted on (here, here, and here), the device appeal process was significantly modified in the Food and Drug Administration Safety and Innovation Act (FDASIA), which created Section 517A of the Federal Food, Drug, and Cosmetic Act (FDC Act). Section 517A defined certain decisions by CDRH (e.g., 510(k) NSE, PMA denial and not-approvable decisions) that were subject to specific timeframes (i.e., appeal must be received by CDRH within 30 days from the decision and date) and bound CDRH to responding to such appeals:
- within 45 days from receipt if an appeal meeting is not requested; or
- within 30 days from an appeal meeting, if requested, and such meeting must be held within 30 days of receipt of the appeal letter.
The 21st Century Cures Act (Cures Act) expanded the list of Agency decisions subject to Section 517A procedures by adding decisions on breakthrough designation requests. In September 2017, CDRH revised its Q&A Guidance to include such decisions on the list of 517A decisions, resulting in the following list of decisions subject to the 517A requirements:
- 510(k): Not Substantially Equivalent; Substantially Equivalent
- PMA/HDE: Not Approvable; Approvable; Approval; Denial
- Breakthrough Devices: Granting; Denial
- IDE: Disapproval; Approval
- Failure to Reach Agreement on a Protocol under Section 520(g)(7) of the FD&C Act
- “Clinical Hold” Determinations under Section 520(g)(8) of the FD&C Act
- 510(k) Requests for Additional Information
- PMA Major Deficiency Letter
- 510(k) and PMA Refuse to Accept Letters
- Postmarket Surveillance Orders under Section 522 of the FD&C Act
- CLIA Waiver Decisions
- Warning Letters
- Response Letter to a Request for Information under Section 513(g) of the FD&C Act
These lists obviously do not cover all FDA decisions. Most notably, de novo submissions are not included. Since FDASIA and the Cures Act (the statutes establishing and revising the device appeal process), de novo submissions have become subject to significant user fees (in excess of $90,000). When CDRH announced its proposed regulations addressing appeals, we hoped FDA would include de novo submissions in the list of 517A decisions, although not required by statute. Certainly given the new price tag, applicants should have the certainty associated with the appeal process for other significant premarket submissions. And, given the increased popularity of de novo applications, more companies are interested in that certainty.
The proposed regulations also do not include any Agency procedures (e.g., timing) for review of non-517A decisions. The notice announcing the proposed regulations does, however, discuss at length the naming of non-517A decisions. Section 517A of the FDC Act pertains to “significant decisions.” In its earlier guidance, FDA used this same terminology referring to 517A decisions as “significant decisions.” FDA stated that it did not want to refer to non-517A decisions as “insignificant decisions” (as may be implied by referring to 517A decisions as “significant”) because they are still important even though not expressly identified in Section 517A. Regardless, however, of what the regulations call these decisions, the lack of Agency procedures for their review highlights their insignificance when it comes to the appeal process and leaves appeals of these decisions at a significant disadvantage as compared to 517A decisions.
Much to our disappointment, the proposed regulations did not address either of these major issues. As indicated at the outset, the proposed regulations simply regurgitate the statutory timeframes and submission types for 517A decisions. With regard to non-517A decisions, the proposed regulations simply state that appeals must be filed by the applicant within 60 days of the decision. There are no requirements for the Agency with regard to reviewing or responding to such appeals. We find the lack of additional clarity and procedures in the proposed guidance somewhat astonishing given that industry and the Agency already understood these procedures and timeframes based on existing guidance. FDA is accepting comments on the proposed regulations through April 17, 2018. We strongly recommend those interested in the appeals process comment. These seemingly arcane procedural elements can help determine the outcome of a submission.
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