Gang Peng Email and Phone Number

• Review the work of over 30 employees to always meeting PDUFA and MDUFA timelines for various submissions(510k, PMA, IDE, QSub, EUA, combination products BLA, IND, NDA and postmarked recalls, fraud) • Provide final regulatory and policy decisions on safety and effectiveness and act as point of contact and resource for all reviewer regulatory and review questions• Identify inefficiencies and shortcomings of team and present solutions such as creating new review practices and templates• Manage short and conflicting deadlines with the available human capital to consistently complete submissions early• Coordinate with other division review teams and subject matter experts Liaison Positions:AAMI DPC WG10 - NeedleAAMI DPC WG11 - SyringeAAMI ID - Infusion Device Committee AAMI IP - Implantable Infusion Pump committee

• Consistently meet or beat all deadlines as lead reviewer and consulting reviewer on submissions(510k, PMA, IDE, QSub, De Novo, EUA), combination products consults(BLA, IND, NDA, CBE30, quality systems) and post market activities(recall, complaint, allegation, signal management)• Division engineer, biocompatibility and chemistry subject matter expert, resolving controversial issues, such as firm appeals, as well create various guidance/templates/division training• Individually mentor multiple hires for a variety of roles(lead reviewer, chemistry reviewer, biocompatibility reviewer), which includes weekly meetings, assignment of files based on learning difficulty, review of completed assignments for feedback and reporting updates to upper management• Trusted interviewer and reviewer of qualifications for potential hiring candidates for various roles• Develop and modify multiple standards and internal practices(ISO 10993-12, ISO 10993-18, ISO 10993-17, ISO 10993-23, syringe/pumps, combination products, nasal spray biocompatibility, etc)• Recipient of multiple awards for industry work completed(Service Award for COVID 19, Quarterly Incentive Award, Honor Awards, Performance Award, etc)

• Collaborate with six commercial laboratories to analysis of ISO 10993 extraction methods, including sample preparation and chemical analysis• Create chemical analysis methods(GC/MS,LC/MS,ICP/MS) subject to the limit of detection and quantification in order to accurately characterize each sample• Process chemical characterization data to quantify and qualify extracted material• Summarize findings and difficulties to reveal possible issues arising from the ISO guidelines • Make suggestions on standards and methods to other groups

Evaluation of Sample Preparation Methods in ISO 10993-12: Impacts of Extraction Conditions• Evaluation of current recommendations of biocompatibility methods for medical device and device materials, especially for extractable and leachable testing • Develop criteria, guidelines, and protocols to generate scientific data to determine the accuracy and completeness of biocompatibility testing in ISO 10993-12:- Cytotoxicity bioassays (MTT, Neutral Red, Alamar Blue, etc.)- Chemical data analysis (i.e. LC/MS, GC/MS) with extractables • Review scientific and technical data for past device applications to understand regulatory requirements and determine the efficacy and safety of a medical device• Present reviews and recommendations to biocompatibility review experts:- Compose recommendations and research paper regarding the acceptance or technical deficiencies of a medical device, Recommendation to ISO 10993:12 (ISO/TC 194/WG 12)- Prepare manuscript to publish findings on biocompatibility testing of medical devices for regulatory and industry use • Deliver presentation on issues found with guidelines on sample preparation methods recommend in ISO 10993 standards- FDA CDRH Center wide presentation- SOT meeting poster • Collaborate with scientists from other offices (office of device evaluation) to exchange information, suggest methodology, and present solutions