The Do’s and Don’ts of Responding to Deficiencies During FDA Premarket Submission Review
January 22, 2018
The majority of medical device companies that submit FDA premarket submissions, including 510(k)s and premarket approval (PMA) applications, receive deficiency letters requesting additional information in order for FDA to reach a decision to allow a device to be sold in the United States. Navigating through the FDA submission review process can be challenging, time-consuming, and labor- and resource-intensive.
The following do’s and don’ts serve as a starting point to help navigate the medical device submission review process more effectively and efficiently.
How NSF Can Help You
Get in touch to find out how we can help you and your business thrive.
What’s New with NSF
NSF Opens Advanced Water Testing Laboratory in Germany
October 17, 2024European manufacturers gain a competitive edge with local NSF/ANSI/CAN 60 and 61 certification testing.
Read the Story
World Food Day: A Global Call to Action for Food Security and Sustainability
October 16, 2024NSF marks World Food Day – a global call to action to raise awareness about the pressing issues of hunger, food security and the importance of sustainable food systems. Established by the Food and Agriculture Organisation (FAO) of the United Nations, this day reminds us of the need to ensure that everyone, everywhere, has access to enough nutritious food.
Read the Story
NSF Welcomes Mel Cash as Chief Commercial Officer
October 14, 2024Global public health and safety organisation announces new Commercial lead to drive growth and innovation.
Read the Story
NSF Spotlighted in “SDG Leaders” Series on CNBC.com
October 3, 2024The docuseries highlights businesses that are addressing core issues within the 17 United Nations (UN) Sustainable Development Goals (SDGs), offering a glimpse into what people can expect as these organisations strive to tackle existential challenges, embedding the sustainability goals at the heart of their work.
Read the Story