Abstract
You have finally compiled all your data into the appropriate package and submitted it to the FDA. Now what? The FDA will begin their review. However, the journey is not over after the FDA completes their review. This chapter provides a summary of the review process indicating the time points when you should anticipate hearing from the FDA. After the review is finished, you will want to market, advertise and promote your device—there are rules to follow. You also have post-marketing requirements, including safety surveillance, periodic reports due to the FDA and tracking requirements. In addition to all of that, there is always the possibility that your device will need an update (new materials, updated user interface, etc.). In the unlikely event that something “bad” happens after marketing, we have provided information about device recalls, corrections and removals.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
References
MDUFA [Medical Device User Fee Amendments (MDUFA)] Performance Goals and Procedures, Fiscal Years 2018 Through 2022, available online at https://www.fda.gov/downloads/forindustry/userfees/medicaldeviceuserfee/ucm535548.pdf (accessed Aug. 31, 2018).
21 C.F.R. § 814.37.
21 C.F.R. § 814.40.
21 C.F.R. § 814.44.
21 C.F.R. § 814.45.
21 C.F.R. § 314.102.
21 C.F.R. § 314.102(c).
21 C.F.R. § 314.102(d).
Lantzy, J. (2015). FDA’s Module 1 Update: From Ideas to Implementation. DIA eRegulatory and Intelligence Annual Conference. Philadelphia, PA.
Gottlieb, S. FDA Statement: Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to enhance and modernize the FDA’s approach to medical device safety and innovation available online at https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm604672.htm (accessed Aug. 31, 2018).
FDA Draft Guidance, Guidance for Industry Presenting Risk Information in Prescription Drug and Medical Device Promotion available online at https://www.fda.gov/downloads/drugs/guidances/ucm155480.pdf (accessed Aug. 31, 2018).
FDA Draft Guidance, Guidance for Industry Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices, available online at https://www.fda.gov/downloads/drugs/guidances/ucm285145.pdf (accessed Aug. 31, 2018).
FDA Guidance, Medical Product Communications That Are Consistent With the FDA-Required Labeling – Questions and Answers Guidance for Industry, available online at https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm537130.pdf (accessed Aug. 31, 2018).
FDA Guidance, Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities – Questions and Answers Guidance for Industry and Review Staff available online at https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm537347.pdf (accessed Aug. 31, 2018).
21 C.F.R. § 814.82.
U.S. Registration No. 4,765,728. Owner: Abiomed, Inc.
FDA PMA Approval Letter to Abiomed, Inc., available online at https://www.accessdata.fda.gov/cdrh_docs/pdf17/P170011A.pdf (accessed Aug. 31, 2018).
Sharrar, RG and Dieck, GS. Monitoring product safety in the postmarketing environment. Ther Adv Drug Saf. 2013:4(5) 211–219.
21 C.F.R. § 807.
21 C.F.R. § 821.
21 C.F.R. § 820.20.
21 C.F.R. § 820.
21 C.F.R. § 814.39.
21 C.F.R. § 1004.
Author information
Authors and Affiliations
Rights and permissions
Copyright information
© 2019 Springer Nature Switzerland AG
About this chapter
Cite this chapter
Halt, G.B., Donch, J.C., Stiles, A.R., VanLuvanee, L.J., Theiss, B.R., Blue, D.L. (2019). During and After Review. In: FDA and Intellectual Property Strategies for Medical Device Technologies. Springer, Cham. https://doi.org/10.1007/978-3-030-04462-6_5
Download citation
DOI: https://doi.org/10.1007/978-3-030-04462-6_5
Published:
Publisher Name: Springer, Cham
Print ISBN: 978-3-030-04461-9
Online ISBN: 978-3-030-04462-6
eBook Packages: EngineeringEngineering (R0)