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FDAMap

Each year FDA receives about 3000 applications for new devices via the 510k process, and about 60% of them are rejected either for poor quality application that cannot even be reviewed or for other technical reasons. Submissions to the FDA that are poorly organized, do not follow current practices, contain inconsistencies between documents, have missing or incomplete content, or poor structure will result in significant delays in the clearance process. With multiple review cycles, up to 90 days each, rejections by FDA could stretch the 510k clearance time-lines to 8 months or more. Most of the refuse-to-accept deficiencies are due to the inexperience of the 510k writers, who ignore the FDA rules. Writing and assembling a complete and well structured 510(k) submission will certainly improve the likelihood of FDA clearance on the first round.

FDA, 510(k) Submissions, FDA Regulations, FDA Compliance

Legislation in der Medizin und Pharmakologie,    Translationale Medizin, Klinische Studien

CHI

Join a global community of thought leaders and innovators shaping the future of bioprocessing. Dive into cutting-edge research, share insights with industry experts, and tackle the challenges of bioprocess R&D, scale-up, quality, and analytics.

Tel.: [781.972.5400];     Email: chi@healthtech.com

CHI

In its 23rd year Discovery on Target is the premier event highlighting “hot” drug targets and emerging modalities, technologies and strategies for pursuing those targets. The numerous conferences, symposia, courses and training seminars offer key insights for the successful discovery and development of novel therapeutics, from small molecules to biologics to chimeras and conjugates. The 4 day event covers innovations in target identification and lead generation, which includes cancer therapies, protein degradation, induced proximity, AI/machine learning, membrane proteins, translational models, synthetic biology and other relevant topics. New this year is an increased coverage of GLP-1, MASH and obesity, ADCs and bispecifics and on small molecules targeting DNA.

Tel.: [781.972.5400];     Email: chi@healthtech.com

Onkologie,    Biotechnologie

Magnus Group

Prepare to immerse yourself in the 5th Edition of the International Vaccines Congress (IVC 2025), taking place from October 23-25, 2025, in the vibrant city of Orlando, Florida, USA! This highly anticipated International Vaccines Congress 2025 will offer a unique hybrid format, seamlessly blending onsite and online experiences to maximize global reach and participation. Dive deep into the latest advancements and transformative trends in vaccine science under the theme: From Discovery to Distribution: The Path of Vaccines.

Tel.: [17029882320];     Email: vaccines@magnusconference.com