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FDA’s 2019 Medical Device Regulation Agenda: Are You Prepared
The CDRH issued two lists of planned final and draft guidances for 2019 — an A-list of guidances it intends to publish and a B-list of guidance it will publish “as resources permit.”
A-list final guidance topics that CDRH plans to issue include unique device identification and compliance dates for Class I and unclassified devices. The A-list draft guidance topics that CDRH plans to publish include premarket submissions for cybersecurity; labeling recommendations for surgical staplers and staples; nonbinding feedback after FDA inspections; lifecycle regulatory requirements for medical device servicing; computer software assurance; content of premarket submissions for software contained in medical devices; and accreditation schemes for device conformity assessments.
Topics for the B-list include: testing considerations for implanted brain-computer interface devices for patients with paralysis or amputations; UDI for convenience kits; and medical x-ray imaging devices conformance with IEC standards.
Jessica Ringel — Counsel, King & Spalding, Washington, D.C. — will discuss how CDRH will prioritize digital health, advance device safety and security, offer more flexibility and options for premarket submissions, sustain high-quality servicing, provide efficient oversight, handle uncertainty in devices and engage patients. You’ll learn about:
Understanding the FDA guidance… programs… and policies that may be on the horizon, as well as those that have been recently announced, will help you prepare for changes in regulatory policy, and utilize advantageous programs.
Jessica Ringel, Counsel, King & Spalding, Washington, D.C.
Jessica Ringel is Counsel in the Washington, D.C., office of King & Spalding and a member of the FDA and Life Sciences practice. Jessica advises medical device and pharmaceutical companies on a wide variety of matters involving FDA regulation, both pre- and post-market. She specializes in post-market matters, including inspections, responses to FDA-483s and Warning Letters, recalls, and other enforcement actions. Jessica also regularly conducts due diligence reviews for manufacturers, private equity firms, and lenders in connection with mergers, acquisitions, investments, and other financial transactions.
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