News

January 29, 2020

CPC Comments on FDA’s Identification of Manufacturing Establishments in CBER/CDER Applications Guidance

On January 29, 2020, the CPC submitted comments on FDA’s “Identification of Manufacturing Establishments in Applications Submitted to CBER and CDER Questions and Answers Guidance for Industry,” which was issued on October 22, 2019. While the CPC appreciates the value of this Guidance in providing FDA’s expectations for identification of manufacturing establishments to facilitate FDA’s review and inspection activities, the CPC has some concerns and suggestions for improvement. For example, we recommend that FDA: (1) limit the scope of sites listed on FDA Form 356h and in Module 3 to those involved in the disposition of commercial product; (2) limit inclusion of FEI number, name and title of onsite contact person, contact details, and confirmation of inspection readiness to Form 356h in accordance with least burdensome approach; and (3) clarify that facilities manufacturing device components/sub-assemblies which are separately provided to combination product manufacturers for further modification/assembly/packaging with the drug constituent part are considered device component manufacturing facilities and should not be listed on Form 356h or in Module 3.

December 26, 2019

CPC Comments on FDA’s “Type V DMFs for CDER-Led Combination Products Using Device Constituent Parts With Electronics or Software Guidance for Industry”

On December 26, 2019, the CPC provided comments on FDA’s “Type V DMFs for CDER-Led Combination Products Using Device Constituent Parts With Electronics or Software Guidance for Industry.” The CPC believes regulatory efficiency and consistency can be improved by the approach proposed by the Agency, which can lead to timely access to new combination products for patients.  To ensure utilization of this approach, however, the CPC strongly recommends that the Draft Guidance better clarify how the rapid, iterative nature of software updates are considered in the process, submissions and amendments for Type V DMFs that contain electronics or software.  In addition, the CPC believes that the Draft Guidance should clarify that the proposed Type V DMF submission approach should be available to all types of platform device constituent parts, not just those containing electronics or software.

December 20, 2019

CPC Provides Comments on FDA’s Reproposed “Clinical Decision Support Software: Draft Guidance for Industry and FDA Staff”

On December 20, 2019, the CPC submitted comments on FDA’s Reproposed “Clinical Decision Support Software: Draft Guidance for Industry and FDA Staff,” which was originally proposed on December 8, 2017. While we appreciate that this reproposed CDS guidance draft moves toward a risk-based approach, we believe it does not go far enough. In particular, the Agency should: (i) apply the same regulatory framework to software regardless of the legal manufacturer, (ii) exclude more software from regulation as low risk; (iii) not try to limit the scope of the Cures Act’s transparency exclusion to only software which, in the IMDRF terminology, merely informs or provides options regarding clinical management of patients; (iv) not limit its enforcement discretion to only patient-directed software that informs clinical management for non-serious situations or conditions; and (v) clarify, with more explicit discussion and specific examples, the level of software description needed to allow intended users to independently evaluate the basis for the software’s recommendation.

August 28, 2019

CPC Comments on FDA’s “Instructions for Use—Patient Labeling for Human Prescription Drug and Biological Products and Drug-Device and Biologic-Device Combination Products—Content and Format: Draft Guidance for Industry”

On August 28, 2019, the CPC submitted comments on FDA’s “Instructions for Use—Patient Labeling for Human Prescription Drug and Biological Products and Drug-Device and Biologic-Device Combination Products—Content and Format: Draft Guidance for Industry.” While the CPC appreciates the value of this Draft Guidance in providing FDA’s expectations for IFUs to ensure a more consistent review experience, especially for combination products, the CPC has some concerns and suggestions for improvement. Specifically, we recommend that FDA revise the document to: (1) clarify that the final layout and content of an IFU should be based on outcomes of the human factors (“HF”) process and the expertise of instructional design professionals, and that the content and layout proposed within the Draft Guidance are suggested, but not required; (2) provide clearer guidance on the criteria by which a manufacturer decides whether a product requires an IFU; (3) clarify the scope of the Draft Guidance; and (4) provide additional guidance on how and when IFUs are to be submitted for review.

August 26, 2019

CPC Comments on FDA’s “New Drugs Regulatory Program Modernization: Improving Approval Package Documentation and Communication”

On August 26, 2019, the CPC filed a comment letter regarding FDA’s “New Drugs Regulatory Program Modernization: Improving Approval Package Documentation and Communication,” and specifically, the proposed new integrated review template. While the CPC supports the integrated review template and acknowledges the value of implementing a system that effectively communicates the basis for new drug approvals, CPC is concerned that the proposed integrated review template will lack the level of detail currently provided in the discipline-specific review memos.  CPC strongly requests that, as FDA implements the integrated review document, the discipline-specific review memos remain publicly available to ensure full transparency and understanding of the Agency’s current thinking with respect to combination product requirements.

May 31, 2019

CPC Comments on FDA’s “Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) – Discussion Paper and Request for Feedback”

On May 31, 2019, CPC filed comments on FDA’s “Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) – Discussion Paper and Request for Feedback” (“Discussion Paper”). While the CPC believes FDA’s proposed approach on AI/ML is well-constructed, we asked that the Agency consider certain general comments/requests, including that FDA: (i) compose any future discussion papers on AI/ML to consider broader and more pressing issues around AI/ML, including use of AI/ML in interpreting real-world and well-controlled clinical data as well as human understanding and interpretation of AI/ML algorithms; (ii) address the critical question of when a continuously adaptive AI/ML may require a premarket submission, as the proposed framework currently addresses only incremental learning algorithms with gating mechanisms for updates; and (iii) provide clarity on what least burdensome AI/ML submissions from industry look like throughout the product lifecycle. We also provided specific responses to the questions posed by FDA in the Discussion Paper.

May 6, 2019

CPC Submits Comments on FDA’s Premarket Pathways Draft Guidance

On May 6, 2019, CPC provided comments on FDA’s “Principles of Premarket Pathways for Combination Products: Draft Guidance for Industry and FDA Staff.” Although the document helps clarify certain FDA expectations, among other feedback, the CPC recommends that FDA: (i) include additional guidance on considerations for cross-labeled combination products with respect to the one v. multiple application determination; (ii) provide additional guidance on when the data and information needed to obtain marketing authorization for a non-lead constituent part either differs or does not differ from that needed as a stand-alone product; and (iii) provide further guidance on how to effectively utilize prior FDA findings of safety or effectiveness or substantial equivalence of an approved or cleared constituent part.

April 9, 2019

CPC Comments on CDER’s Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality Draft Guidance

On April 9, 2019, CPC provided comments on FDA’s proposed CDER Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality. Our comment letter asks FDA to provide a number of clarifications in the Draft Guidance, including: (1) confirming that the scope of the Draft Guidance includes combination products under CDER jurisdiction; (2) clarifying how the proposed CDER Program will align with the CDRH Standards and Conformity Assessment Program for the device constituent(s) of combination products under CDER jurisdiction; (3) clarifying how the informal nature of the CDER Program will ensure predictability and consistency across CDER for the same device constituent and the same standard; and (4) clarifying the type of standards that are expected to be a part of the CDER Program.

March 7, 2019

CPC Provides Comments on FDA’s Proposed Rule for the Medical Device De Novo Classification Process

On March 7, 2019, CPC provided feedback on the proposed rule for the Medical Device De Novo Classification Process. As part of this feedback, CPC notes that it concurs with and supports the applicability of the De Novo process to the device constituent of what are commonly referred to as “cross-labeled” combination products, and asks FDA to consider including “co-packaged” combination products (per 21 C.F.R. § 3.2(e)(2)) that are designated as device mode of action in the De Novo process, as such products would also benefit from the application of least burdensome provisions and potentially classification as Class II devices.

January 22, 2019

CPC Comments on FDA’s Proposed Framework for Regulating Software Intended for Use with Prescription Drugs

On January 22, 2019, CPC provided input on the Federal Register Notice entitled “Prescription Drug-Use-Related Software; Establishment of a Public Docket; Request for Comments.” While the CPC applauds the Agency’s efforts to develop a proposed framework to address the ever-increasing array of digital innovations associated with pharmaceuticals, the CPC has certain concerns regarding the proposed framework, as discussed within the comment letter.

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