Successfully gaining CE Mark & FDA approval in the highly regulated field of dermal fillers and medical treatments/devices for aesthetic indications requires expertly executed clinical trials, highly accurate data collection and analysis, and a thorough understanding of the application process.
For more than 30 years, HPA has been providing consulting expertise to the end-to-end process of bringing innovative new medical devices and biologics for aesthetic indications to market in both the US and Europe. HPA brings an unmatched breadth of expertise guiding medical and biotechnology manufacturers through the end-to-end product development process of products for aesthetic indications, with specific expertise in dermal fillers, facial sutures, lasers, and neurotoxins and other injectables.
Guiding the end-to-end development of products for aesthetic indications through FDA approval
HPA’s expertise in the end-to-end process of bringing innovative new medical devices and biologics, including hyaluronic acid-based (HA) dermal fillers or injectables for aesthetic indications in the US market includes:
- Initial documentation/data gap assessment for FDA readiness.
- Preparing and leading clients through FDA PMA general and plastic surgery panel meetings.
- Guiding dozens of IDE, 510(k), and PMA applications through the general and plastic surgery branch of FDA.
- Executing numerous trials including CRF design, database build, site training, monitoring, data analysis and report writing for a wide variety of indications including:
- Nasolabial fold (NLF)
- Marionette line correction
- Lip augmentation
- Glabellar correction
- Dorsum of hand correction
- Peri-orbital/infraorbital hollow
- Designing customized electronic clinical databases for multiple dermal filler indications.
- Designing, hosting and analyzing results of Independent Photo Reviews.
- Conducting mock audits and training site staff in preparation for FDA inspections, resulting in ‘no findings’ inspections for KOLs.
- Successfully submitting SAS coding and analysis for several indications to FDA, focusing on validated effectiveness scales.
- Training and qualifying of reviewers for quality results with high intra- and inter-rater kappa scores.
HPA’s Capabilities for CE Mark Approval of Aesthetic Technologies
HPA brings extensive experience to the end-to-end process of developing new products for aesthetic indications in Europe.
Dermal Filler CE Mark experience includes:
- Positioned CE Mark approval for US-based dermal filler company (under active NDA) for multiple applications.
- Positioned CE Mark approval for OUS-based dermal filler company (under active NDA).
- Lead author in multiple CE Mark submissions currently pending approval.
Overall CE Mark expertise includes:
- Initial documentation/data gap assessment for CE Mark readiness.
- Identification of applicable CE Mark Directives
- Devising strategies for assessing and selecting Notified Bodies
- Assessment and assignment of appropriate device classifications
- Full-service support for compiling and submitting a CE Mark design dossier/technical file
- Design/implementation of a compliant Quality Management System (QMS) consistent with ISO 13485:2016
- Preparation/review/editing of QMS documentation/SOP’s, user manuals and labelling
- Identification of applicable standards and testing requirements/strategies
- Full-service CRO for clinical trials in support of CE Mark approval and Post-Market Clinical Follow-up (PMCF) studies
- Implementation or assessment of Post Market Surveillance (PMS) activities, including PMS SOP, device-specific PMS Plans, and preparation of Clinical Evaluation Reports (CERs).
- Preparation for Notified Body audits
- Responses to audit or technical file non-conformances issues by Notified Bodies
- Biostatistical expertise with dermal filler
- In-house SAS programmers