The medical device approval process can be a churning sea of regulations and reviews. We are experienced navigators.
The Arent Fox Food and Drug practice handles a wide variety of matters involving Food and Drug Administration regulation of medical devices, including product development, counseling, and other matters.
In the area of product development, we regularly advise clients when there is a need to submit a 510(k) pre-market notification for a particular type of device and, if necessary, then prepare and submit 510(k) notifications. In addition, we advise clients on Pre-market Approval Application (PMA) requirements and assist clients with the preparation of PMAs and Investigational Device Exemptions (IDE). We assist clients with their product development plans, and are involved in the entire process of product development, including coordination with investigators, institutions and Contract Research Organizations; drafting research and license agreements; representing companies before the FDA on IDEs, 510(k)s and PMAs; appearing before advisory committees; advising on pre-market approval inspections by FDA; performing pre-FDA inspection audits; and all other areas of product development.
Recent product development-related activities of attorneys in our group include:
- Advising clients on the regulatory status and availability of patent protection of testing modalities
- Obtaining 510(k) notification “substantial equivalence” letters for a wide variety of products, including bioresorbable pins used in periodontal and other surgery, bone filling augmentation materials, a personal lubricant, condoms, ophthalmic surgery products, sunlamps, surgical gloves, medical stockings, telemedicine devices, menstrual cups, dental floss, cardiac products, dental cements, periodontal membranes, and other diverse products
- Advising clients on a variety of products and providing assurance that FDA pre-market notification was or was not necessary – including telemedicine products, dental porcelain, a breath gas analyzer, and other dental devices
- Preparing and filing IDEs for periodontal surgery devices, orthopedic products, and other diverse products
- Advising a client on a biologic skin product that the FDA is regulating as a medical device
- Conducting a pre-FDA approval audit of a foreign contract sterilizer named in a pending 510(k) notification
- Preparing numerous agreements with institutions and investigators for development of medical device products and coordinating with Contract Research Organizations in development of cardiac and dental products
In the area of regulatory counseling, we advise clients on all aspects of regulatory issues involving marketed medical device products. We regularly review and advise clients on proposed advertising, labeling, and promotional materials, including websites. We are involved in responding to warning letters and Notice of Violation letters involving various types of alleged violations of the Federal Food, Drug and Cosmetic Act, including advertising issues, manufacturing issues, adverse event reporting issues, and the like. We are also involved in handling recalls of medical devices; advising on the Quality System Regulation (QSR); conducting regulatory, compliance and due diligence audits of facilities where medical devices are produced; advising clients on pending rulemaking and filing comments thereon; advising clients on reporting of adverse events concerning medical device products, and on device malfunctions; and assisting with registration and listing compliance. We also regularly appear before the FDA on these types of matters.
Recent regulatory-related activities of attorneys in our group include:
- Drafting and reviewing standard operating procedures involving blood borne pathogens
- Responding to warning letters and Notice of Violation letters involving advertising of medical device products, including allegedly violative website materials
- Drafting and submitting comments on proposed regulations involving dental devices
- Conducting third-party audits of medical device facilities
- Conducting a nationwide audit of a major device distributor, including on-site audits of eight facilities and document audits of another 20 locations
- Appearing before the FDA on the possible reclassification of a dental device product
- Representing a client who received a warning letter alleging that it was marketing an unapproved medical device
- Advising financial entities on FDA-related issues involving publicly traded medical device companies
- Conducting pre-FDA QSR inspections, for inspections that resulted in no 483 observations
