Regulatory, Compliance, and Quality System Support Contract
Blueprint MedTech awarded a contract (75N95022D00020) to PPD, a contract research organization (CRO), to provide regulatory affairs services and resources to participating Blueprint MedTech grantees in support of regulatory documentation and regulatory compliance for supporting medical device development projects from pre-clinical through clinical phases. This contractor will provide support for regulatory consulting advice, preparation and submission of regulatory documents including Q-submissions, Investigational Device Exemption (IDE), 510(k), De Novo, Pre-market Approval (PMA), Humanitarian Device Exemption (HDE), and post-approval studies, interaction with US FDA, establishment of a Quality System, setup of a regulatory compliance program, and assistance with market/user research and commercialization strategy and with evaluating and obtaining reimbursement/payer coverage.
Areas for Regulatory Advising:
1: Preparation of Medical Device Pre-Submissions and 513(g) Request for Information
The Contractor shall provide services related to the preparation of all necessary pre-market regulatory submissions for medical devices including traditional pre-submissions, breakthrough device designation requests, study risk determination requests, and 513(g) Request for Information. Anticipated activities under this area include but are not limited to:
- Obtaining and reviewing preclinical and clinical information needed for the submission.
- Preparing, drafting, reviewing, and/or submitting the pre-submission meeting request and briefing package and other supporting documentation as needed.
- Managing post-meeting responses and communications.
- Conducting a debriefing meeting.
2: Preparation and Filing of Investigational Device Exemption (IDE) Submissions
The Contractor shall provide services related to the preparation and filing of an IDE. Anticipated activities under this area include but are not limited to:
- Conducting IDE kick-off meeting.
- Defining IDE filing strategy, scope, timeline, and responsibilities.
- Preparing all modules of the IDE, which includes tasks such as:
a. Collecting all study reports, summaries, synopses, and other required documentation.
b. Drafting and writing regulatory documents of the submission.
c. Preparing all forms necessary for submission.
- Providing post-IDE filing support, including formal responses and maintenance activities as needed.
3: Regulatory Services for Clinical Studies
The Contractor shall provide regulatory services related to clinical studies. Such studies may be clinical trials, natural history studies, patient finding studies, or others. Anticipated activities under this area include but are not limited to:
- Planning, requesting, and preparing materials for additional types of informal and formal meetings.
- Tracking and managing study-related regulatory documentation (e.g., protocol amendments, severe adverse event [SAE] reporting).
- Supporting clinical protocol(s) and clinical trial(s) to ensure compliance with Good Clinical Practice (GCP). This may include tasks such as reviewing study regulatory files and subject specific documents such as informed consent, case report forms, medical records, and communication with the regulatory agency and Investigational Review Board (IRB).
4: Regulatory Support for Medical Device Marketing Submissions
The Contractor shall provide services related to marketing submissions including 510(k), DeNovo, PMA, HDE, Q-submissions, and post-approval studies. Anticipated activities under this area include but are not limited to:
- Determining the regulatory requirements.
- Preparing, drafting, reviewing, and/or submitting documentation to the appropriate regulatory body (e.g., FDA/CDRH).
- Providing post-submission filing support including communications, responses, and maintenance activities as needed.
- Providing technical guidance and subject matter expertise, which may include tasks such as reviewing data, overseeing studies at CROs, and preparing and reviewing study reports and summaries.
5: Regulatory Support for Establishing a Quality System
The contractor shall provide regulatory services related to establishment of a Quality System. Anticipated activities under this area may include but are not limited to:
- Creation / establishment of Quality System.
- Improvement of existing Quality System.
- Quality System software validation.
- Audit and Inspection preparation.
- Design change support.
6: Establishing a Regulatory Compliance Program
The contractor shall provide regulatory services related to establishment of a regulatory compliance program. Anticipated activities under this area may include but are not limited to:
- Development of compliance program.
- Compliance and ethics training for staff.
- Conflict of Interest management.
- Preparation for audits and investigations.
- Establishing a compliance manual.
- Assisting with compliance management outsourcing, if applicable.
7: Assistance with market/user research and commercialization strategy
The contractor shall provide assistance with market and user research and commercialization strategy for the medical device product. Anticipated activities under this area include but are not limited to:
- Market analysis, including market size, market drivers and barriers to entry.
- Competitive landscape analysis.
- Clinical adoption analysis.
- Commercialization/marketing strategy.
8: Assistance with evaluating and obtaining reimbursement/payor coverage.
The contractor shall provide assistance with assessing strategies for reimbursement and payor coverage of the medical device. Anticipated activities under this area include but are not limited to:
- Engaging with CMS and private payors to obtain necessary information about the organization’s needs for coverage decisions.
- Developing evidence generation plan to support payor coverage.
- Establishing medical coverage codes.