A Medical Device Daily

The Securities and Exchange Commission (SEC) last week unveiled the successor to the agency's 1980s-era EDGAR database, which dates back to the 1980s.

SEC said the new IDEA system — short for Interactive Data Electronic Applications — will give investors "far faster and easier access to key financial information about public companies and mutual funds."

IDEA is based on a completely new architecture being built from the ground up. It will at first supplement and then eventually replace the EDGAR system.

The decision to replace EDGAR marks the SEC's transition from collecting forms and documents to making the information itself freely available to investors to give them better and more up-to-date financial disclosure in a form they can readily use.

"IDEA will ensure that the SEC continues to stay ahead of the needs of investors," said agency Chairman Christopher Cox. "This new SEC resource powered by interactive data will give investors far faster, more accurate, and more meaningful information about the companies and mutual funds they own."

He added, "IDEA's launch represents a fundamental change in the way the SEC collects and publishes company and fund information – and in the way that investors will be able to use it."

Most SEC filings currently are available only in government-prescribed forms through EDGAR. Investors looking for information must sift through one form at a time, and then re-keyboard the information.

The agency said that with IDEA, investors will be able to "instantly" collate information from thousands of companies and forms, and create reports and analysis in any way they choose.

The SEC said that IDEA will ensure that both the agency and the investors who rely upon the financial reporting it demands are ready for the new world of financial disclosure that will arrive when financial information is presented in interactive data format.

The agency has formally proposed requiring U.S. companies to provide financial information using interactive data beginning as early as next year, and separately has proposed requiring mutual funds to submit their public filings using interactive data.

The SEC noted that Interactive data relies on computer "tags," similar in function to bar codes, which identify individual items in a company's financial disclosures.

With every number on an income statement or balance sheet individually labeled, information about thousands of companies contained on thousands of forms could be easily searched on the Internet, downloaded into spreadsheets, reorganized in databases, and put to any number of other comparative and analytical uses by investors, analysts, journalists, and financial intermediaries.

The ease with which interactive data will make financial information available is expected to generate many new web-based services and products for investors.

When he unveiled the new IDEA platform at a Washington news conference last week, Cox said that the IDEA logo will begin to appear immediately on the SEC's web site as the agency transitions to making it the new primary source for all SEC filings.

Companies' interactive data filings are expected to be available through IDEA beginning late this year.

Those who use EDGAR will be able to continue doing so for the indefinite future. During the transition to IDEA, new interactive, IDEA-like features will be grafted onto EDGAR in the short run to make it possible for investors to tap IDEA's advanced search capabilities, and to use the information from EDGAR within spreadsheets and analytical software, which never was possible with EDGAR.

The EDGAR database will continue to be available as an archive of company filings for past years.

AdvaMed hails payment code plans

Advanced Medical Technology Association (AdvaMed; Washington) President/CEO Stephen Ubl had praise for the U.S. Department of Health and Human Services' proposed adoption of ICD-10 code sets.

"AdvaMed is very pleased that Secretary Michael Leavitt has released proposed regulations that will help modernize America's healthcare system by implementing the ICD-10 classification system," Ubl said. "The new system will improve the accuracy of the data used by CMS and private insurers for quality and public health reporting."

He added, "The new set of payment codes also will better identify and describe new medical procedures and technologies and play a critical role in the movement toward a national electronic health information system, helping to eliminate inefficiencies in the healthcare system."

Ubl said AdvaMed will continue to review the proposed regulations and plans to provide comments during the public comment period.

Routine amendments made by FDA

FDA said it is amending a regulatory hearing process regulation to correct an inaccurate citation, and regulations pertaining to biological products to correct two typographical errors.

The agency said it also is amending certain medical device regulations to include references to and mailing address information for the Center for Biologics Evaluation and Research (CBER), Center for Drug Evaluation and Research (CDER), and Center for Devices and Radiological Health (CDRH).

FDA is amending 21 CFR 16.1 to correct an inaccurate citation and is amending 21 CFR 610.51 and 21 CFR 640.53 to correct typographical errors.

The agency said it also is amending its medical device regulations in 21 CFR 812, 814, and 860 to include references to and mailing addresses for CBER and CDER, and 21 CFR 822.8 to correct an inadvertent omission of the mailing address for CDRH.

It noted that submissions regarding a medical device must be sent to the address of the appropriate center that has regulatory responsibility for the device, so it is updating the regulations to include address information for the appropriate centers.