THE U.S. MEDICAL DEVICE INDUSTRY ACCOUNTS FOR NEARLY 20% OF THE GLOBAL INDUSTRY
The US is the largest medical device country in the world in both consumption and production. Some of the most innovative and largest medical device companies originate in the US.
The US Food and Drug Administration (FDA) is the regulatory body over medical devices, among other products. In order to receive approval for their medical devices, businesses must submit documentation to the FDA for approval. The type of documentation depends on the device classification, Class I, II or III with Class I being the least risky and Class III being the most risky. Documentation can include reports demonstrating safety and effectiveness, labeling, instructions for use and more. For higher risk devices, clinical data may also be required.
FDA has issued several guidance documents to help manufacturers understand FDA’s current thinking of the topic. These are updated regularly and new Guidance is issued as needed. In 2016, FDA Center for Devices and Radiological Health (CDRH)issued Guidance on Cybersecurity and Human Factors Engineering among other topics. You can view all guidance documents on the FDA site: http://www.fda.gov/RegulatoryInformation/Guidances/
Manufacturers of approved medical devices are required to comply with Quality System Requirements (QSR) and subject to an FDA Inspection. This is typically unscheduled and if deficiencies are noted may result in penalties.
In addition to FDA, depending on the technology and materials used, medical devices may also be required to get approvals from other agencies, such as UL, FCC, CDRH (X-ray) and more.
Once you get approval from FDA, in order to generate revenue, unless the device is expected to be paid for by the patient, the company will need to convince the private health insurance companies, and government healthcare programs to cover the device and/or the procedures.
August 2, 2016: Guidance Document: Determining Donor Eligibility for Autologous Donors of Blood and Blood Components Intended Solely for Autologous Use – Compliance Policy
August 3, 2016: Draft Guidance: Medical X-Ray Imaging Devices Conformance with IEC Standards
August 8, 2016: Draft Guidance: Deciding When to Submit a 510(k) for a Change to an Existing Device
August 8, 2016: Draft Guidance: Deciding When to Submit a 510(k) for a Software Change to an Existing Device
August 15, 2016: Guidance Document: Premarket Notifications [510(k)] Submissions for Bipolar Electrosurgical Vessel Sealers for General Surgery
August 15, 2016: Guidance Document: Premarket Notification [510(k)] Submissions for Electrosurgical Devices for General Surgery
August 16, 2016: Guidance Document: FY 2017 Medical Device User Fee Small Business Qualification and Certification
August 24, 2016: Guidance Document: Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications
September 12, 2016: Draft Guidance Document: 510(k) Third Party Review Program
October 12, 2016: Rule: Medical Devices; Custom Devices; Technical Amendment
October 14, 2016: Draft Guidance: Software as a Medical Device (SaMD): Clinical Evaluation
October 17, 2016: Proposed Rule: Electronic Submission of Labeling for Certain Home-Use Medical Devices
November 8, 2016: Guidance Document: Medical Device Reporting for Manufacturers
December 27, 2016: Guidance Document: Factors to Consider Regarding Benefit-Risk in Medical Devices Product Availability, Compliance, and Enforcement Decisions
December 28, 2016: Guidance Document: Postmarket Management of Cybersecurity in Medical Devices
December 30, 2016: Guidance Document: Medical Device Accessories – Describing Accessories and Classification Pathway for New Accessory Types
January 9, 2017: NIST Releases Update to Cybersecurity Framework
January 13, 2017: FDA released draft guidance on human factors studies pertaining to generic drug-device combination products
January 1, 2017: Act 137 SLH 2016 – Durable Medical Equipment Supplier Licensing
June 28, 2016: Senate Bill: Senate Bill No. 794: An Act to repeal section 144.030, Rsmo, and to enact in lieu thereof one new section relating to a sales tax exemption on parts and accessories for medical equipment.
December 13, 2016: Public Law No. 114-255: 21st Century Cures Act
January 1, 2017: Rule: Chapter 2246-226 WAC, Radiation Protection – Computed Tomography