Worldwide Medical Device Regulatory Updates

As medical device quality assurance and regulatory affairs professionals, it can be challenging to stay on top of changes happening in our industry. Few people have the time to read lengthy articles these days and although many online newsletters exist, they are often packed with PR releases, ads or unrelated information. That\'s why we started this blog for QA/RA professionals in the medical device and IVD industry. The idea is to give you short updates on quality and regulatory topics that may be of interest to you. No fluff, just straight to the point. We hope you\'ll enjoy the content.

CDRH Issues Additional Import Entry Review Process Recommendations

The US FDA’s Center for Devices and Radiological Health (CDRH) has issued an update to its Letter to Industry about Import Entry Review Process from March 2011 specifying which Affirmation if Compliance (AofC) codes to use for radiation-emitting medical devices imported into the US market.

Using correct AofC codes can help ensure that medical device imports are not held up for further FDA entry review prior to distribution, marketing and sales in the US, according to the new CDRH letter. Medical device manufacturers as well as their importing and distribution partners shipping radiation-emitting electronic medical devices should adjust their processes accordingly to avoid US market entry delays.

Radiation-emitting electronic products, many of which have medical technology applications, are subject to US federal performance standards and regulated by CDRH, 21 CFR Parts 1000-1005 and US Customs and Border Protection (CBP) regulations 19 CFR 12.91. Such products include video display monitors using cathode ray tubes, diagnostic x-ray systems and components, laser products and ultrasonic therapy systems.

Importers of any radiation-emitting electrical products subject to federal performance standards must submit information for each shipment to both the FDA and CBP, and affirm whether their products comply with performance standards.

Radiation-emitting electronic medical devices subject to federal performance standards must submit appropriate AofC codes listed in the FDA’s March 24, 2011 letter as well as AofC codes applicable to both medical devices and radiation-emitting electrical products provided in the new notice:

Medical Device AofC Codes	Electronic Product Radiation Control AofC Codes
• Device Foreign Manufacturer (DEV) or Device Foreign Exporter (DFE)	• EPRC Accession Number (ACC) or EPRC Annual Report Number (ANC)
• Device Listing (LST)	• EPRC Model Number (MDL)
• Device Initial Importer (DII)	• Affirmation code from Form FDA-2877
• Premarket Application (PMA), Premarket Notification Number (PMN) or Investigational Device Exemption (IDE)

Questions regarding AofC codes and the US import entry review process should be addressed to the CDRH Office of Compliance Import/Export Safety Staff: cdrhocimport [at] fda [dot] hhs [dot] gov, with the subject line “EPRC Inquiries.”

Markets: USATags: aofc, CDRH, FDA, import entry review, medical device

Author: Stewart EisenhartDate: September 9, 2011

CDRH Updates Import Entry Review Process for Medical Devices

The US FDA’s Center for Devices and Radiological Health (CDRH) has issued recommendations to improve medical device import entry review processes to expedite entry of foreign-made products into the US.

In a March 24 Letter to Industry, CDRH director of compliance Steven Silverman noted agency concerns about the number of imported medical devices lacking adequate entry data necessary for timely admission into the US by the FDA.

“These recommendations will directly impact your company’s ability to import medical devices, electronic product components, parts and finished products into the US,” writes Silverman.

The agency is seeking to speed up admittance of submissions with correct Affirmation of Compliance (AofC) data—and persuade more medical device importers to ensure that their shipments adhere to AofC requirements to avoid the need for extended FDA entry reviews.

Failure to provide adequate AofC data, Silverman advises, often results in manual reviews of product entries, causing significant delays.

Accordingly, the FDA has published new and revised AofC codes for use in transmission of medical device import entries. All entries should include AofC codes for Device Foreign Manufacturer (DEV) or Device Foreign Exporter (DFE), Device Listing (DL), Device Initial Importer (DII) and Premarket Application (PMA), which can also be a Humanitarian Device Exemption (HDE), Product Development Protocol (PDP) number, Premarket Notification Number (PMN) or Investigational Device Exemption (IDE).

Although use of the afore-mentioned codes remains voluntary, the CDRH emphasizes that their use will result in more efficient and faster reviews of imported devices.

Silverman also notes that a separate letter addressing import entry filing processes for products subject to both medical device and electronic product radiation requirements is forthcoming from the agency.

The letter advises that questions regarding the FDA’s import entry review process be sent to the CDRH’s Office of Compliance Import/Export Safety Staff at cdrhocimport@fda.hhs.gov.