CLSA Applauds Introduction of New Bill to Improve Medical Device Inspections
April 24, 2017
CLSA is proud to endorse bipartisan legislation introduced on March 27 by Representatives Larry Bucshon (R-Ind.), Scott Peters (D-San Diego), Susan Brooks (R-Ind.) and G.K. Butterfield (D-N.C.) to improve the process for FDA inspections of medical device establishments and granting export certifications. California is home to over 1,700 medical device companies, providing approximately 75,000 jobs in vibrant medical technology clusters up and down the state.
CLSA strongly supports H.R. 1736, which will improve transparency, predictability, efficiency, and consistency around inspections of California’s medical device manufacturers and ensure timely patient access to life-saving medical devices. The bill, H.R. 1736, proposes four key improvements:
- Risk-based inspections: Establishes a risk-based schedule for inspections to focus limited federal resources on the more significant risks to public health while reducing the burden on establishments with a strong history of compliance.
- Improvements to inspections process: Standardizes and enhances processes associated with communications prior to, during, and after inspections. Also, proposes enhanced training opportunities for investigators to improve consistency and efficiency of the device inspection process.
- Guidance: Requires the development of a draft guidance document that details the implementation process and requirements imposed by the legislation.
- Export Certificates for Foreign Governments: Ensures devices that are lawfully marketed for United States patients will no longer be denied certification for marketing in other countries by requiring written justification for denial and summary of deficiencies if FDA refuses to issue an export certificate.
Working in collaboration with our member companies and our national trade association partner, AdvaMed, CLSA supported the inclusion of key elements of the legislation and secured California Representative Scott Peters, a member of the critical House Energy & Commerce Committee, as an original lead sponsor. We are working to secure additional cosponsors of the bill, and advocating for swift action on this legislation this year. A copy of our letter of endorsement of H.R. 1736 is available here.
Questions? Please contact Jenny Carey, CLSA’s Vice President of Federal Government Relations and Alliance Development (firstname.lastname@example.org).