The call by the FDA to supply safety and effectiveness data on 25 types of medical devices sold before 1976 is receiving favorable industry support.

The FDA will make a more thorough review of components — including metal hip joints, spinal screws, and dental implants — which had been sold before 1976 without agency approval and evaluation. The move comes after criticism from the Government Accountability Office in January.

Consumer groups say it is critical for older products to be thoroughly tested because companies use them as the basis to bring updated technology to the market. Manufacturers can sometimes sell newer devices if they are proven “substantially equivalent” to a previous product.

The Advanced Medical Technology Association (AdvaMed) supports the FDA’s move to complete the assessment of the older products.

“However, it needs to be clearly understood that the device types subject to the FDA notice have already been thoroughly reviewed by the agency involving the submission and evaluation of relevant technological and performance data, and in some cases, clinical data,” says Janet Trunzo, an executive vice president at AdvaMed.

Under the FDA's order, manufacturers must provide descriptions of the devices and how they are used, summaries on safety and effectiveness, and other information. The data must be supplied within 120 days. Companies should already have the information and will not be required to run new studies.

The FDA classifies medical devices based on the level of risk to patients. After review, the agency will decide if the products can be categorized as less risky, or if they need to go through the highest level of review to win approval. “Class III” are the most risky and are subject to the most rigorous level of review.

If the agency determines the devices reviewed are Class III, companies can submit clinical data for possible FDA approval, or they may withdraw the product from the market. Those who keep selling products without review may face legal troubles.

Medtronic Inc, a Minneapolis medical device maker, says the review should not hurt its sales, but because new devices are often based off old ones, some products approved as recently as last month may need to be reviewed. Medtronic spokesman Chuck Grothaus says the company is still determining which devices it will need to submit data on, but in most cases it has 30 years of evidence to prove the devices are properly classified under the FDA's guidelines and are safe and effective. Grothaus notes that pulling a product from the market is always an option.