Legal and Regulatory Sites of Interest to Medical Device Manufacturers
 

KEY LINK

The Regulatory Affairs Professionals Society (RAPS) is an international membership organization of regulatory professionals in the rapidly growing medical device, pharmaceutical and biotechnology sectors. As regulatory professionals, RAPS members perform vital work in all areas of the healthcare product lifecycle, ensuring these products are safe and effective, while driving organizational strategy and sound decision-making. RAPS supports these individuals and the regulatory profession as a whole by providing education and training, certification, professional standards, research, knowledge-sharing, publications, networking and career development opportunities and other valuable resources; and is committed to helping its members continually develop the knowledge and skills they need to excel.


 

ALL LINKS

The Agency for Health Care Policy and Research (AHCPR), a part of the Public Health Service within the U.S. Department of Health and Human Services, is the lead federal agency charged with supporting research designed to improve the quality of healthcare, reduce its cost, and broaden access to essential services. AHCPR sponsors and conducts research that provides evidence-based information on healthcare outcomes, quality, cost, use, and access. The information helps healthcare decision makers—patients and clinicians, health system leaders, and policymakers—make more-informed decisions and improve the quality of healthcare services.

Centers for Medicare and Medicaid Services (CMS) provides health insurance for 75 million elderly, disabled, and low-income Americans through Medicare and Medicaid. As a federal agency within the Department of Health and Human Services, CMS develops coverage policies, regulates laboratory testing, and oversees certification of nursing homes and continuing-care providers.

CenterWatch. A listing of more than 41,000 combined industry- and government-sponsored clinical trials.

ClinicalTrials.gov. A place to search for research studies being conducted by the National Institutes of Health (NIH), other federal government agencies, and pharmaceutical companies.

The Code of Federal Regulations. When you need to check FDA regulations, this site, also from the House of Representatives, allows you to search by title and section number, word, and topic, among other alternatives.

Device Advice, a self-help service from CDRH, is perhaps the best source of information for anyone entering the medical device market. The interactive program takes you step by step through everything you need to know and do to get your product on the market.

Dedicated to improving and preserving the quality of the national and global environment, the Environmental Protection Agency (EPA) works to ensure that federal environmental laws are implemented and enforced effectively. Additionally, the EPA takes steps to ensure that economic development and environmental protection are integrated in U.S. foreign and domestic policy, and that public and private decisions affecting energy, transportation, agriculture, industry, international trade, and natural resources fully integrate considerations of environmental quality.

The Export-Import Bank of the United States is an independent government agency that helps finance the overseas sales of U.S. goods and services. The bank’s mission is to create jobs through exports. It guarantees workingcapital loans for U.S. exporters and the repayment of loans by foreign purchasers of U.S. goods and services. The agency also offers export credit insurance policies to protect against political and commercial risks of a foreign buyer defaulting on payment.

FDA's Center for Devices and Radiological Health. The CDRH site is clearly the first stop for regulatory information. It includes a center overview, recent CDRH federal register notices, blue book memoranda, and much more. Contact information for each department and program area is provided on the CDRH Referral List.

The Food and Drug Administration's Home Page. The parent site of CDRH offers general agency information and access to other FDA centers and to the Office of Regulatory Affairs. And if you need titles and contact information for staff members, you can try searching the Health and Human Services directory.

FDA's Electronic Reading Room contains an index of frequently requested FDA documents (rendered here to cut down on the number of FOI requests the agency gets). Categories include compliance policy guides, enforcement reports, inspectors' technical guides, medical devices reports (MDRs), product approval listings, and warning letters.

The Federal Trade Commission (FTC) promotes business competition in the United States and polices anticompetitive practices. The commission also works to prevent false advertising of consumer products through the regulation of packaging and labeling, and is the primary federal agency responsible for enforcing regulations related to on-line fraud and privacy issues. Its work is divided into the bureaus of Consumer Protection, Competition, and Economics.

National Institutes of Health Clinical Center. A searchable listing of research studies being conducted at the NIH Clinical Center.

The primary goal of the National Institute of Standards and Technology (NIST) is to promote U.S. economic growth by working with industry to develop and apply technology, measurements, and standards. Its major programs are a rigorously competitive Advanced Technology Program that provides cost-shared grants to industry for development of high-risk technologies with significant commercial potential; a grassroots Manufacturing Extension Partnership that helps small and medium-sized companies adopt new technologies; a strong laboratory effort planned and implemented in cooperation with industry and focused on measurements, standards, evaluated data, and test methods; and a highly visible quality outreach program associated with the Malcolm Baldrige National Quality Award.

NSSN: A National Resource for Global Standards provides US, foreign, regional, and international standards and regulatory documents for purchase or free download, when possible. Users can subscribe to the Standards Tracking and Automated Reporting (STAR) service, which notifies them via e-mail whenever a particular standard gets updated or altered.

The U.S. Nuclear Regulatory Commission regulates the civilian use of by-product materials in the United States to protect the public health and safety, the environment, and the common defense and security. The agency reviews and issues licenses for construction and operation of nuclear power plants and other nuclear facilities, and it licenses the possession and use of nuclear materials for research and medical, industrial, and educational purposes.

The Occupational Safety and Health Administration (OSHA) develops and promulgates occupational safety and health standards, develops and issues regulations, conducts investigations and inspections to determine the status of compliance with safety and health standards and regulations, and issues citations and proposes penalties for noncompliance. OSHA enters into partnership agreements to promote workplace safety and health, and engages in training and outreach programs to educate employers and employees.

The Occupational Safety and Health Review Commission, an independent federal agency, decides contests of citations or penalties resulting from OSHA inspections of the workplace. The commission has established procedures for conducting hearings, receiving evidence, and rendering decisions by its administrative law judges.

A primary responsibility of the U.S. Department of Commerce Office of Microelectronics, Medical Equipment, and Instrumentation (OMMI) is to promote exports and increase international competitiveness of the U.S. medical device industry. The office helps firms promote medical products in international markets. Programs include working with industry to develop trade missions, exhibitions, and seminars that promote exports; participating in and supporting trade negotiations to increase U.S. exports and international investments abroad; reducing and eliminating regulatory barriers that impede trade; and preparing industry analysis reports that affect U.S. competitiveness and future trends. OMMI and the Commercial Service organize a significant number of medical device trade events each year.

RegSource features links to regulatory news of interest to medical device manufacturers. A device industry directory offers information ranging from upcoming conferences and meetings to standards and GMPs. Links to FDA's Federal Register and Title 21 of the U.S. Code are also available. A searchable database of Federal Register notices, as well as information on regulatory forms and warning letters, is provided.

The Regulatory Affairs Professionals Society (RAPS) is an international membership organization of regulatory professionals in the rapidly growing medical device, pharmaceutical and biotechnology sectors. As regulatory professionals, RAPS members perform vital work in all areas of the healthcare product lifecycle, ensuring these products are safe and effective, while driving organizational strategy and sound decision-making. RAPS supports these individuals and the regulatory profession as a whole by providing education and training, certification, professional standards, research, knowledge-sharing, publications, networking and career development opportunities and other valuable resources; and is committed to helping its members continually develop the knowledge and skills they need to excel.

The U.S. Small Business Administration (SBA) provides new and established small businesses with financial assistance, management counseling, and training. The administration also licenses and regulates small business investment companies. Special programs have been developed by SBA to expand and promote ownership of businesses by women and minorities.

Thomas: U.S. Legislative Information. This site offers the fully searchable text of House and Senate bills as well as the full text of the Congressional Record.

The United States Code. This browseable version of the U.S. Code from the House of Representatives gopher offers a quick way to find U.S. laws covering the device industry by title and section numbers (you'll generally want Title 21). If you need to do a search by keywords, the Cornell University Law School provides a searchable version.

The U.S. Patent & Trademark Office Database covers the period from January 1, 1976 to the most recent weekly issue date. The database consists of the full text of US patents (including utility, design, reissue, plant and SIR patents). The full text of a patent includes all bibliographic data, such as the inventor's name, the patent's title, and the assignee's name, as well as the abstract, the full description of the invention, and the claims.

Washington Information Source Co., and it's RECORD-RETRIEVE Document Retrieval & Research Service produces four FDA regulatory compliance newsletters-- Warning Letter Bulletin, Food & Drug Inspection Monitor, Validation Times and Adverse Event Reporting News. All subscribers can use RECORD-RETRIEVE to obtain 483s, EIRs, warning letters and responses, 510(k)s, PMA summaries and NDA/BLA review information, plus adverse experience data. WIS also publishes regulatory compliance manuals and research CDs, including directories of FDA personnel and a DVD of warning letters and 510(k)s.