Medical devices are part of our everyday lives; they include simple items such as tongue depressors to complex imaging technology. All devices must be approved by the FDA’s Center for Devices and Radiological Health (CDRH) before they can be sold in the United States; and they are regulated under 21 CFR Part 820. Devices are classified as Class I, II, or III and the regulatory requirements vary for each class.
Medical devices can also be combined with drug products and/or biological products to create Combination Products. The products can be regulated by various divisions of the FDA [Center for Biologics Evaluation and Research (CBER), the Center for Drug Evaluation and Research (CDER), and the Center for Devices and Radiological Health (CDRH)] depending on what components are in the product. Combination products must comply with the regulations outlined in 21 CFR Part 4. The various regulatory pathways can create unique challenges for companies wishing to bring a combination product to market. Examples of combination products are metered dose inhalers, pre-filled syringes, auto-injector pens, transdermal patches, and nasal sprays.
Jeiven provides comprehensive Quality and Regulatory strategy consulting to medical device, drug/device combination product, and in vitro diagnostic device companies. Additionally, we provide auditing and training to medical device companies. Our team of medical device experts has experience with medical devices, drug/device combination products, in-vitro diagnostics, drug delivery and iontophoretic products across all classes spanning a diverse range of indications including transdermal patches, metered dose inhalers, nasal sprays, auto injector pens, pre-filled syringes, etc.
We can assist with design requirements as well as device regulatory strategies, preparing for and going to FDA meetings, and review of FDA submissions; and all aspects of Quality consulting related to Medical Devices and Combination Products.
Consulting expertise includes:
- Advise on regulatory strategy, timelines, and pathway routes for market entry of new/modified products
- Review product labeling
- Provide support in creation of Design History File (DHF)
- Draft and/or review design control documentation for products, which may include establishment of DDP, DIR, RMP, risk analysis, design verification/validation, human factors testing, etc.
- Review of human factors reports or any required threshold analysis
- Help draft or review relevant sections of NDA (New Drug Application) for combination products
- Audits/qualifications of device and/or combination product related CMOs (contract manufacturing organizations), as needed and possible support related to drafting and/or review of Quality Agreements
- Help in establishment of Quality Systems related to combination product, as needed and help remediate non-compliant Quality systems
- Assist with Quality System Regulations (QSR) Compliance
- Conduct Quality System assessments/Gap Analysis audits
- QA oversight of GMP documentation at CMOs for device and/or combination product
- Provide remediation services after receiving an FDA Form 483, Warning Letter, Consent Decree, or Import Detentions, and implement CAPA plans to remediate internal Quality Systems
- Advise and implement remediation plans: Quality Systems, 483s, Warning Letters, Import Detentions
- Review of Device Master Records (DMRs) and Device History Records (DHRs) (to ensure that batches are produced as per GMPs and identify & resolve potential deviations/ discrepancies prior to approval of batch records
- Review and approve of stability protocols and stability reports as needed for device and/or combination products
- Review and approve change management as it relates to changes to specifications, process, equipment, facility, analytical methods, etc. at CMOs as it relates to device and/or combination products
- Participate in risk analysis (user, design, process) product including review of risk analysis reports
- Author SOPs and review existing SOPs
- Assist with creating procedures and processes to manage world-wide Product Recalls/MDRs/Vigilance/Adverse Event Reporting
- Review and provide strategic advice on domestic and international regulatory submissions:
- 513(g) Request for Information Submissions
- 510(k) (Premarket Approval) Submissions
- CE Marking (technical file/design dossier)
- CLIA Waiver
- FDA Presub
- Canadian Medical Device License
- Investigational Device Exemption (IDE) Submissions
- De Novo Request Submissions
- Import/Export Documents including Certificate to Foreign Government/Certificate to Free Sale, Canada Device Licenses, etc.
- Humanitarian Use Designation (HUD)/Humanitarian Device Exemption (HDE) Submissions
- Provide guidance on clinical protocols, package inserts, risk management reports, etc. for FDA submissions
- Conduct audits of medical device suppliers including Class III
- Provide consulting related to the conduct of clinical trials including:
- Monitor the conduct of medical device/IVD clinical trials including verifying subject safety and site adherence to FDA regulations and ICH/GCP Guidelines and trial protocols
- Ensure Adverse Events are reported appropriately;
- Review Case Report Forms (CRF), Informed Consent documents, Investigator Financial Disclosure forms
- Conduct Qualification, Initiation, Interim, and Closeout monitoring visits
- Please visit our medical device auditing page for more information about audits and our medical device training page for information about our customized training offerings